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Han X, Wang C, Zhang Q, Guan B, Zhang H, Yu Y, Tang J, Gao X, Meng J, Li C, Zhou H, Huang X, Shi H, Bian T, Hu G, Jiang Q, Li H, Li L, Li X, Lin C, Liu D, Liu J, Ma H, Tan G, Wan L, Xia J, Xiao S, Xie J, Xing Z, Qu S, Zhao C, Zhu L, Zhang Y, Zhang L. Efficacy and safety of azelastine hydrochloride and fluticasone propionate nasal spray in treating allergic rhinitis: A randomized controlled trial. Asia Pac Allergy 2025; 15:7-14. [PMID: 40051423 PMCID: PMC11882219 DOI: 10.5415/apallergy.0000000000000161] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/15/2024] [Accepted: 08/30/2024] [Indexed: 03/09/2025] Open
Abstract
Background MP-AzeFlu (Dymista; Meda Pharma GmbH & Co., KG), a formulation combining azelastine hydrochloride and fluticasone propionate in a single spray, is superior to fluticasone propionate alone in relieving symptoms and improving the quality of life of patients with allergic rhinitis. Objectives In this study, we evaluated whether the effect of AzeFlu, a generic drug manufactured from China, is equivalent to that of MP-AzeFlu. Methods In total, 679 patients were recruited for a multicentre, randomized, double-blind, original drug-controlled, and parallel-group clinical trial. Overall, 339 and 340 patients were administered with AzeFlu and MP-AzeFlu, respectively. Efficacy was assessed by changes in the reflective total nasal symptom score, the area under the curve of reflective total nasal symptom score changes over time, changes from baseline in individual nasal symptom scores, and the Rhinoconjunctivitis Quality of Life Questionnaire. In addition, a safety evaluation was simultaneously performed. Results AzeFlu and MP-AzeFlu reduced the reflective total nasal symptom score from baseline (AzeFlu -6.7 [standard deviation, 2.59]; MP-AzeFlu -6.7 [standard deviation, 2.76]; P = 0.905) and improved nasal symptoms and quality of life (AzeFlu -62.3 [standard deviation, 33.59]; MP-AzeFlu -64.7 [standard deviation, 33.73]; P = 0.394) in patients with allergic rhinitis. Significant differences were not observed between groups. Conclusion AzeFlu showed effects equivalent to those of MP-AzeFlu in this clinical trial and may benefit Chinese patients with allergic rhinitis.Registration number: CTR20190189 (chinadrugtrials.org.cn/index.html).
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Affiliation(s)
- Xinling Han
- Department of Allergy, Beijing TongRen Hospital, Capital Medical University, Beijing, People’s Republic of China
- Beijing Key Laboratory of Nasal Diseases, Beijing Institute of Otolaryngology, Beijing, People’s Republic of China
- Department of Otolaryngology Head and Neck Surgery, Beijing TongRen Hospital, Capital Medical University, Beijing, People’s Republic of China
- Research Unit of Diagnosis and Treatment of Chronic Nasal Disease, Chinese Academy of Medical Sciences, Beijing, People’s Republic of China
| | - Chengshuo Wang
- Department of Allergy, Beijing TongRen Hospital, Capital Medical University, Beijing, People’s Republic of China
- Beijing Key Laboratory of Nasal Diseases, Beijing Institute of Otolaryngology, Beijing, People’s Republic of China
- Department of Otolaryngology Head and Neck Surgery, Beijing TongRen Hospital, Capital Medical University, Beijing, People’s Republic of China
- Research Unit of Diagnosis and Treatment of Chronic Nasal Disease, Chinese Academy of Medical Sciences, Beijing, People’s Republic of China
| | - Qinna Zhang
- Department of Otolaryngology, First Hospital of Shanxi Medical University, Taiyuan (Shanxi), People’s Republic of China
| | - Bing Guan
- Department of Otolaryngology, Northern Jiangsu People’s Hospital, Yangzhou (Jiangsu), People’s Republic of China
| | - Hua Zhang
- Department of Otolaryngology, Xinjiang Medical University Affiliated First Hospital, Urumchi (the Xinjiang Uygur Autonomous Region), People’s Republic of China
| | - Yafeng Yu
- Department of Otolaryngology, The First Affiliated Hospital of Soochow University, Suzhou, Jiangsu, People’s Republic of China
| | - Jinyong Tang
- Department of Otolaryngology Head and Neck Surgery, Chenzhou First People’s Hospital, Chenzhou, Sichuan, People’s Republic of China
| | - Xiaoping Gao
- Department of Otolaryngology Head and Neck Surgery, General Hospital of Ningxia Medical University, Yinchuan (Ningxia), China
| | - Juan Meng
- Department of Otolaryngology, West China Hospital of Sichuan University, Chengdu, Sichuan, People’s Republic of China
| | - Chao Li
- Department of Otolaryngology, The Second Hospital of Tianjin Medical University, Tianjin, People’s Republic of China
| | - Huifang Zhou
- Department of Otolaryngology, Tianjin Medical University General Hospital, Tianjin, People’s Republic of China
| | - Xinsheng Huang
- Department of Otolaryngology, Zhongshan Hospital, Fudan University, Shanghai, People’s Republic of China
| | - Haiyun Shi
- Department of Allergy, Beijing Shijitan Hospital, Capital Medical University, Beijing, People’s Republic of China
| | - Tao Bian
- Department of Respiratory Medicine, Wuxi People’s Hospital, Wuxi, Jiangsu, People’s Republic of China
| | - Guohua Hu
- Department of Otolaryngology, The First Affiliated Hospital of Chongqing Medical University, Chongqing, China
| | - Qingshan Jiang
- Department of Otolaryngology, The First Affiliated Hospital of University of South China, Hengyang, Hunan, People’s Republic of China
| | - Huabin Li
- Department of Otolaryngology, The Eye and Ent Hospital of Fudan University, Shanghai, People’s Republic of China
| | - Lingbo Li
- Department of Otolaryngology, Liuzhou Worker’s Hospital, Liuzhou, Guangxi, People’s Republic of China
| | - Xianhua Li
- Department of Otolaryngology, Affiliated Zhongshan Hospital of Dalian University, Dalian, Liaoning, People’s Republic of China
| | - Chang Lin
- Department of Otolaryngology, First Affiliated Hospital of Fujian Medical University, Fuzhou, Fujian, People’s Republic of China
| | - Dingrong Liu
- Department of Otolaryngology Head and Neck Surgery, The Second People’s Hospital of Neijiang, Neijiang, Sichuan, People’s Republic of China
| | - Jixiang Liu
- Department of Otolaryngology, Tianjin People’s Hospital, Tianjin, People’s Republic of China
| | - Huaan Ma
- Department of Otolaryngology, Jiangsu Province Hospital of Chinese Medicine, Nanjing, Jiangsu, People’s Republic of China
| | - Guolin Tan
- Department of Otolaryngology, Central South University Third Xiangya Hospital, Changsha, Hunan, People’s Republic of China
| | - Lijia Wan
- Department of Otolaryngology, Jingzhou Central Hospital, Jingzhou, Hubei, People’s Republic of China
| | - Jiao Xia
- Department of Otolaryngology Head and Neck Surgery, Beijing Friendship Hospital, Capital Medical University, Beijing, People’s Republic of China
| | - Shuifang Xiao
- Department of Otolaryngology, Peking University First Hospital, Beijing, People’s Republic of China
| | - Jinghua Xie
- Department of Otolaryngology Head and Neck Surgery, Guangzhou First People’s Hospital, Guangzhou, Guangdong, People’s Republic of China
| | - Zhimin Xing
- Department of Otolaryngology, Peking University People’s Hospital, Beijing, People’s Republic of China
| | - Shenhong Qu
- Department of Otolaryngology Head and Neck Surgery, The People’s Hospital of Guangxi Zhuang Autonomous Region, Nanning, Guangxi, People’s Republic of China
| | - Changqing Zhao
- Department of Otolaryngology Head and Neck Surgery, Second Hospital of Shanxi Medical University, Taiyuan, Shanxi, People’s Republic of China
| | - Li Zhu
- Department of Otolaryngology, Peking University Third Hospital, Beijing, People’s Republic of China
| | - Yuan Zhang
- Department of Allergy, Beijing TongRen Hospital, Capital Medical University, Beijing, People’s Republic of China
- Beijing Key Laboratory of Nasal Diseases, Beijing Institute of Otolaryngology, Beijing, People’s Republic of China
- Department of Otolaryngology Head and Neck Surgery, Beijing TongRen Hospital, Capital Medical University, Beijing, People’s Republic of China
- Research Unit of Diagnosis and Treatment of Chronic Nasal Disease, Chinese Academy of Medical Sciences, Beijing, People’s Republic of China
| | - Luo Zhang
- Department of Allergy, Beijing TongRen Hospital, Capital Medical University, Beijing, People’s Republic of China
- Beijing Key Laboratory of Nasal Diseases, Beijing Institute of Otolaryngology, Beijing, People’s Republic of China
- Department of Otolaryngology Head and Neck Surgery, Beijing TongRen Hospital, Capital Medical University, Beijing, People’s Republic of China
- Research Unit of Diagnosis and Treatment of Chronic Nasal Disease, Chinese Academy of Medical Sciences, Beijing, People’s Republic of China
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Solé D, Kuschnir FC, Pastorino AC, Constantino CF, Galvão C, Chong E Silva DC, Baptistella E, Goudouris ES, Sakano E, Ejzenbaum F, Matsumoto FY, Mizoguchi FM, Aarestrup FM, Wandalsen GF, Chong Neto HJ, Brito de Oliveira JV, Lubianca Neto JF, Rizzo MCV, Silva Chavarria MLF, Urrutia-Pereira M, Filho NAR, de Paula Motta Rubini N, Mion O, Piltcher OB, Ramos RT, Francesco RD, Roithmann R, Anselmo-Lima WT, Romano FR, de Mello Júnior JF. V Brazilian Consensus on Rhinitis - 2024. Braz J Otorhinolaryngol 2025; 91:101500. [PMID: 39388827 PMCID: PMC11497470 DOI: 10.1016/j.bjorl.2024.101500] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/14/2024] [Accepted: 08/17/2024] [Indexed: 10/12/2024] Open
Abstract
Since we published the "IV Brazilian Consensus on Rhinitis", in2017, several advances have been achieved and have enabled a further understanding of the different aspects of "Rhinitis". This new guideline, developed jointly by ASBAI, SBP and SBORL, represents a relevant milestone in the updated and integrated management of the different forms of the disease, and it aims to unify evidence-based approaches to improve the diagnosis and treatment of this common and often underestimated condition. The document covers a wide range of topics, including clear definitions of the different phenotypes and endotypes of rhinitis, risk factors, updated diagnostic criteria, and recommended methods for clinical and laboratory investigation. We stress the importance of detailed clinical history and objective assessment, as well as tools for control and assessing severity tools an accurate diagnostic approach to the disease. Regarding treatment, it emphasizes the treatment customization, considering the severity of symptoms, the presence of comorbidities and the impact on the patient's quality of life. We discuss different drug treatment, in addition to non-pharmacological measures, such as environmental control and specific immunotherapy; and the possible role of immunobiological agents. Furthermore, the consensus addresses issues related to patient education, prevention and management of special situations, such as rhinitis in children, in pregnant women and in the elderly. In short, the "V Brazilian Consensus on Rhinitis" represents a comprehensive and updated guide for healthcare professionals involved in the diagnosis and management of rhinitis, aiming to improve patients' quality of life through an integrated and evidence-based approach.
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Affiliation(s)
- Dirceu Solé
- Universidade Federal de São Paulo, Escola Paulista de Medicina, São Paulo, SP, Brazil; Sociedade Brasileira de Pediatria, Rio de Janeiro, RJ, Brazil
| | - Fábio Chigres Kuschnir
- Associação Brasileira de Alergia e Imunologia, São Paulo, SP, Brazil; Universidade do Estado do Rio de Janeiro, Rio de Janeiro, RJ, Brazil
| | - Antônio Carlos Pastorino
- Sociedade Brasileira de Pediatria, Rio de Janeiro, RJ, Brazil; Universidade de São Paulo, São Paulo, SP, Brazil
| | - Clóvis F Constantino
- Sociedade Brasileira de Pediatria, Rio de Janeiro, RJ, Brazil; Universidade de Santo Amaro, São Paulo, SP, Brazil
| | - Clóvis Galvão
- Associação Brasileira de Alergia e Imunologia, São Paulo, SP, Brazil; Universidade de São Paulo, São Paulo, SP, Brazil
| | - Débora Carla Chong E Silva
- Sociedade Brasileira de Pediatria, Rio de Janeiro, RJ, Brazil; Universidade Federal do Paraná́, Curitiba, PR, Brazil
| | - Eduardo Baptistella
- Associação Brasileira de Otorrinolaringologia e Cirurgia Cérvico-Facial, São Paulo, SP, Brazil
| | - Ekaterini Simões Goudouris
- Sociedade Brasileira de Pediatria, Rio de Janeiro, RJ, Brazil; Universidade Federal do Rio de Janeiro, Rio de Janeiro, RJ, Brazil
| | - Eulália Sakano
- Associação Brasileira de Otorrinolaringologia e Cirurgia Cérvico-Facial, São Paulo, SP, Brazil; Universidade Estadual de Campinas, Campinas, SP, Brazil
| | - Fábio Ejzenbaum
- Sociedade Brasileira de Pediatria, Rio de Janeiro, RJ, Brazil; Faculdade de Ciências Médicas da Santa Casa de São Paulo, São Paulo, SP, Brazil
| | - Fausto Yoshio Matsumoto
- Universidade Federal de São Paulo, Escola Paulista de Medicina, São Paulo, SP, Brazil; Sociedade Brasileira de Pediatria, Rio de Janeiro, RJ, Brazil
| | - Flavio Massao Mizoguchi
- Associação Brasileira de Otorrinolaringologia e Cirurgia Cérvico-Facial, São Paulo, SP, Brazil
| | - Fernando Monteiro Aarestrup
- Associação Brasileira de Alergia e Imunologia, São Paulo, SP, Brazil; Universidade Federal de Juiz de Fora, Juiz de Fora, MG, Brazil
| | - Gustavo F Wandalsen
- Universidade Federal de São Paulo, Escola Paulista de Medicina, São Paulo, SP, Brazil; Sociedade Brasileira de Pediatria, Rio de Janeiro, RJ, Brazil
| | - Herberto José Chong Neto
- Sociedade Brasileira de Pediatria, Rio de Janeiro, RJ, Brazil; Universidade Federal do Paraná́, Curitiba, PR, Brazil
| | | | - José Faibes Lubianca Neto
- Sociedade Brasileira de Pediatria, Rio de Janeiro, RJ, Brazil; Fundação Universidade Federal de Ciências da Saúde de Porto Alegre, Porto Alegre, RS, Brazil
| | | | | | - Marilyn Urrutia-Pereira
- Associação Brasileira de Alergia e Imunologia, São Paulo, SP, Brazil; Universidade Federal do Pampa, Uruguaiana, RS, Brazil
| | - Nelson Augusto Rosário Filho
- Associação Brasileira de Alergia e Imunologia, São Paulo, SP, Brazil; Universidade Federal do Paraná́, Curitiba, PR, Brazil
| | - Norma de Paula Motta Rubini
- Associação Brasileira de Alergia e Imunologia, São Paulo, SP, Brazil; Universidade Federal do Estado do Rio de Janeiro, Rio de Janeiro, RJ, Brazil
| | - Olavo Mion
- Universidade de São Paulo, São Paulo, SP, Brazil; Associação Brasileira de Otorrinolaringologia e Cirurgia Cérvico-Facial, São Paulo, SP, Brazil
| | - Otávio Bejzman Piltcher
- Associação Brasileira de Otorrinolaringologia e Cirurgia Cérvico-Facial, São Paulo, SP, Brazil; Universidade Federal do Rio Grande do Sul, Porto Alegre, RS, Brazi
| | - Regina Terse Ramos
- Sociedade Brasileira de Pediatria, Rio de Janeiro, RJ, Brazil; Universidade Federal da Bahia, Salvador, BA, Brazil
| | - Renata Di Francesco
- Sociedade Brasileira de Pediatria, Rio de Janeiro, RJ, Brazil; Universidade de São Paulo, São Paulo, SP, Brazil
| | - Renato Roithmann
- Associação Brasileira de Otorrinolaringologia e Cirurgia Cérvico-Facial, São Paulo, SP, Brazil; Universidade Luterana do Brasil, Canos, RS, Brazil
| | - Wilma Terezinha Anselmo-Lima
- Associação Brasileira de Otorrinolaringologia e Cirurgia Cérvico-Facial, São Paulo, SP, Brazil; Universidade de São Paulo, Faculdade de Medicina de Ribeirão Preto, Ribeirão Preto, SP, Brazil
| | - Fabrizio Ricci Romano
- Universidade de São Paulo, São Paulo, SP, Brazil; Associação Brasileira de Otorrinolaringologia e Cirurgia Cérvico-Facial, São Paulo, SP, Brazil
| | - João Ferreira de Mello Júnior
- Universidade de São Paulo, São Paulo, SP, Brazil; Associação Brasileira de Otorrinolaringologia e Cirurgia Cérvico-Facial, São Paulo, SP, Brazil.
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Rosenfield L, Keith PK, Quirt J, Small P, Ellis AK. Allergic rhinitis. ALLERGY, ASTHMA, AND CLINICAL IMMUNOLOGY : OFFICIAL JOURNAL OF THE CANADIAN SOCIETY OF ALLERGY AND CLINICAL IMMUNOLOGY 2024; 20:74. [PMID: 39731198 DOI: 10.1186/s13223-024-00923-6] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Subscribe] [Scholar Register] [Received: 09/16/2024] [Accepted: 11/13/2024] [Indexed: 12/29/2024]
Abstract
Allergic rhinitis (AR) is a common disorder that is strongly linked to asthma and conjunctivitis. Classic symptoms include nasal congestion, nasal itch, rhinorrhea and sneezing. A thorough history, physical examination and assessment of allergen sensitization are important for establishing the diagnosis of AR. Intranasal corticosteroids and second-generation antihistamines are the mainstay of treatment. Allergen immunotherapy is an effective immune-modulating treatment for use in addition to or as an alternative to pharmacologic therapy. This article provides an overview on the pathophysiology, diagnosis, and appropriate management of AR.
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Affiliation(s)
- Lana Rosenfield
- Department of Internal Medicine, University of Manitoba, Winnipeg, MB, Canada.
| | - Paul K Keith
- Division of Clinical Immunology and Allergy, Department of Medicine, McMaster University, Hamilton, ON, Canada
| | - Jaclyn Quirt
- Division of Clinical Immunology and Allergy, Department of Medicine, McMaster University, Hamilton, ON, Canada
| | - Peter Small
- Jewish General Hospital, Montreal, QC, Canada
| | - Anne K Ellis
- Division of Allergy & Immunology, Department of Medicine, Queen's University, Kingston, ON, Canada
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Qin JY, Huang G, Pan ZH, Liao LF, Hu HF. Different medications for seasonal allergic rhinitis in adults: A systematic review and meta-analysis. World J Meta-Anal 2024; 12:98508. [DOI: 10.13105/wjma.v12.i4.98508] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 06/28/2024] [Revised: 10/13/2024] [Accepted: 11/12/2024] [Indexed: 12/12/2024] Open
Abstract
BACKGROUND While the efficacy of medications such as fluticasone furoate (FF), fluticasone propionate (FP), and azelastine-fluticasone (AF) has been substantiated in comparison to their respective placebo controls, uncertainties persist regarding the comparative effectiveness of different intranasal agents.
AIM To evaluate the efficacy of FP, FF, and AF in the treatment of adult patients with seasonal allergic rhinitis (SAR) using a meta-analytic approach.
METHODS A computer search was conducted in Cochrane Library, PubMed, and EMBASE databases to identify randomized controlled trials assessing the effectiveness and safety of FF, FP, and AF in treating SAR. Data on treatment safety and efficacy were extracted and analyzed through meta-analysis.
RESULTS A total of 20 studies were included, comprising 10590 participants. The results of the direct meta-analysis indicated that, compared to placebo, both relative Total Nasal Symptom Score (rTNSS) and relative Total Ocular Symptom Score (rTOSS) significantly decreased post-intervention [mean difference (MD) = -1.48, 95% confidence interval (CI): -1.73 to -1.22; MD = -0.66, 95%CI: -0.82 to -0.49], with similar findings observed across the FF, FP, and AF subgroups. The network meta-analysis results showed that for improving rTNSS and rTOSS, the SUCRA values ranking from highest to lowest were AF, FP, FF, and placebo. Improvements in rTNSS and rTOSS with FP, FF, and AF were all significantly greater than those observed with placebo, with AF demonstrating superior efficacy compared to both FP and FF. No statistically significant difference in rTNSS improvement was found between FP and FF, although FP exhibited significantly greater improvement in rTOSS compared to FF.
CONCLUSION In adult patients with SAR, the combination of azelastine and fluticasone shows a significant effect in improving nasal and ocular symptoms, with FP demonstrating marked improvement in ocular symptoms compared to FF.
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Affiliation(s)
- Jiang-Yuan Qin
- The Third Department of Surgery, Guangxi Armed Police Corps Hospital, Nanning 530021, Guangxi Zhuang Autonomous Region, China
| | - Geng Huang
- Department of Health, Guangxi Armed Police Corps, Nanning 530021, Guangxi Zhuang Autonomous Region, China
| | - Zhi-Hui Pan
- The Third Department of Surgery, Guangxi Armed Police Corps Hospital, Nanning 530021, Guangxi Zhuang Autonomous Region, China
| | - Lan-Fang Liao
- The Third Department of Surgery, Guangxi Armed Police Corps Hospital, Nanning 530021, Guangxi Zhuang Autonomous Region, China
| | - Heng-Fen Hu
- Medical School, Hunan Vocational and Technical College of Environmental Biology, Hengyang 421005, Hunan Province, China
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Sousa-Pinto B, Vieira RJ, Brozek J, Cardoso-Fernandes A, Lourenço-Silva N, Ferreira-da-Silva R, Ferreira A, Gil-Mata S, Bedbrook A, Klimek L, Fonseca JA, Zuberbier T, Schünemann HJ, Bousquet J. Intranasal antihistamines and corticosteroids in allergic rhinitis: A systematic review and meta-analysis. J Allergy Clin Immunol 2024; 154:340-354. [PMID: 38685482 DOI: 10.1016/j.jaci.2024.04.016] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/06/2023] [Revised: 04/08/2024] [Accepted: 04/16/2024] [Indexed: 05/02/2024]
Abstract
BACKGROUND There is insufficient systematized evidence on the effectiveness of individual intranasal medications in allergic rhinitis (AR). OBJECTIVES We sought to perform a systematic review to compare the efficacy of individual intranasal corticosteroids and antihistamines against placebo in improving the nasal and ocular symptoms and the rhinoconjunctivitis-related quality of life of patients with perennial or seasonal AR. METHODS The investigators searched 4 electronic bibliographic databases and 3 clinical trials databases for randomized controlled trials (1) assessing adult patients with seasonal or perennial AR and (2) comparing the use of intranasal corticosteroids or antihistamines versus placebo. Assessed outcomes included the Total Nasal Symptom Score, the Total Ocular Symptom Score, and the Rhinoconjunctivitis Quality-of-Life Questionnaire. The investigators performed random-effects meta-analyses of mean differences for each medication and outcome. The investigators assessed evidence certainty using the GRADE (Grading of Recommendations, Assessment, Development and Evaluation) approach. RESULTS This review included 151 primary studies, most of which assessed patients with seasonal AR and displayed unclear or high risk of bias. Both in perennial and seasonal AR, most assessed treatments were more effective than placebo. In seasonal AR, azelastine-fluticasone, fluticasone furoate, and fluticasone propionate were the medications with the highest probability of resulting in moderate or large improvements in the Total Nasal Symptom Score and Rhinoconjunctivitis Quality-of-Life Questionnaire. Azelastine-fluticasone displayed the highest probability of resulting in moderate or large improvements of Total Ocular Symptom Score. Overall, evidence certainty was considered "high" in 6 of 46 analyses, "moderate" in 23 of 46 analyses, and "low"/"very low" in 17 of 46 analyses. CONCLUSIONS Most intranasal medications are effective in improving rhinitis symptoms and quality of life. However, there are relevant differences in the associated evidence certainty.
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Affiliation(s)
- Bernardo Sousa-Pinto
- CINTESIS@RISE, Centre for Health Technology and Services Research, Health Research Network, Faculty of Medicine, University of Porto, Porto, Portugal; MEDCIDS, Department of Community Medicine, Information and Health Decision Sciences, Faculty of Medicine, University of Porto, Porto, Portugal
| | - Rafael José Vieira
- CINTESIS@RISE, Centre for Health Technology and Services Research, Health Research Network, Faculty of Medicine, University of Porto, Porto, Portugal; MEDCIDS, Department of Community Medicine, Information and Health Decision Sciences, Faculty of Medicine, University of Porto, Porto, Portugal
| | - Jan Brozek
- Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada; Department of Medicine, McMaster University, Hamilton, Ontario, Canada
| | - António Cardoso-Fernandes
- CINTESIS@RISE, Centre for Health Technology and Services Research, Health Research Network, Faculty of Medicine, University of Porto, Porto, Portugal; MEDCIDS, Department of Community Medicine, Information and Health Decision Sciences, Faculty of Medicine, University of Porto, Porto, Portugal
| | - Nuno Lourenço-Silva
- CINTESIS@RISE, Centre for Health Technology and Services Research, Health Research Network, Faculty of Medicine, University of Porto, Porto, Portugal; MEDCIDS, Department of Community Medicine, Information and Health Decision Sciences, Faculty of Medicine, University of Porto, Porto, Portugal
| | - Renato Ferreira-da-Silva
- CINTESIS@RISE, Centre for Health Technology and Services Research, Health Research Network, Faculty of Medicine, University of Porto, Porto, Portugal; MEDCIDS, Department of Community Medicine, Information and Health Decision Sciences, Faculty of Medicine, University of Porto, Porto, Portugal
| | - André Ferreira
- MEDCIDS, Department of Community Medicine, Information and Health Decision Sciences, Faculty of Medicine, University of Porto, Porto, Portugal; Unit of Anatomy, Department of Biomedicine, Faculty of Medicine, University of Porto, Porto, Portugal; Department of Ophthalmology, Centro Hospitalar Universitário do Porto, Porto, Portugal
| | - Sara Gil-Mata
- CINTESIS@RISE, Centre for Health Technology and Services Research, Health Research Network, Faculty of Medicine, University of Porto, Porto, Portugal; MEDCIDS, Department of Community Medicine, Information and Health Decision Sciences, Faculty of Medicine, University of Porto, Porto, Portugal
| | | | - Ludger Klimek
- Department of Otolaryngology, Head and Neck Surgery, Universitätsmedizin Mainz, Mainz, Germany; Center for Rhinology and Allergology, Wiesbaden, Germany
| | - João A Fonseca
- CINTESIS@RISE, Centre for Health Technology and Services Research, Health Research Network, Faculty of Medicine, University of Porto, Porto, Portugal; MEDCIDS, Department of Community Medicine, Information and Health Decision Sciences, Faculty of Medicine, University of Porto, Porto, Portugal
| | - Torsten Zuberbier
- Institute of Allergology, Charité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany; Fraunhofer Institute for Translational Medicine and Pharmacology, Immunology, and Allergology, Berlin, Germany
| | - Holger J Schünemann
- Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada; Department of Medicine, McMaster University, Hamilton, Ontario, Canada
| | - Jean Bousquet
- ARIA, Montpellier, France; Institute of Allergology, Charité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany; Fraunhofer Institute for Translational Medicine and Pharmacology, Immunology, and Allergology, Berlin, Germany.
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Tantilipikorn P, Kirtsreesakul V, Bunnag C, Vangveeravong M, Thanaviratananich S, Chusakul S. The Use of Azelastine Hydrochloride/Fluticasone Propionate in the Management of Allergic Rhinitis in Asia: A Review. J Asthma Allergy 2024; 17:667-679. [PMID: 39045291 PMCID: PMC11264124 DOI: 10.2147/jaa.s451733] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Download PDF] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/25/2023] [Accepted: 05/13/2024] [Indexed: 07/25/2024] Open
Abstract
The incidence of allergic rhinitis (AR) in Asia and the world is steadily rising. Patients experience incomplete symptom relief despite existing treatment options, which warrants the need for new therapeutic regimes. Azelastine hydrochloride/fluticasone propionate (MP-AzeFlu), a novel intranasal formulation of azelastine hydrochloride and fluticasone propionate has been indicated in the treatment of AR. The current review discusses the effects of MP-AzeFlu versus conventional therapies in achieving superior clinical improvement with a very rapid onset of action (5 minutes). The superiority of MP-AzeFlu in offering complete symptom control with sustained relief in patients with AR compared to the existing therapeutic options is also discussed. MP-AzeFlu has been shown to improve the quality of life for patients with AR, thereby enhancing patient adherence to therapy and establishing its preference for the treatment of AR. Currently, the Allergic Rhinitis and its Impact on Asthma (ARIA) guidelines recommend the use of a combination of intranasal corticosteroids and intranasal antihistamines as first-line treatment in patients with persistent AR with visual analog scores ≥5 or when prior treatment with single agents has been ineffective. Widely published data on the efficacy and safety of its prolonged use in adults and children have validated that effective treatment of AR can be achieved with MP-AzeFlu.
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Affiliation(s)
- Pongsakorn Tantilipikorn
- Center of Research Excellence in Allergy & Immunology, Faculty of Medicine Siriraj Hospital, Bangkok, Thailand
| | - Virat Kirtsreesakul
- Department of Otolaryngology, Faculty of Medicine, Prince of Songkla University, Hat Yai, Songkhla, Thailand
| | - Chaweewan Bunnag
- Department of Otorhinolaryngology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand
| | | | | | - Supinda Chusakul
- Department of Otolaryngology, Chulalongkorn University, Bangkok, Thailand
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Klimek L, Mullol J, Ellis AK, Izquierdo-Domínguez A, Hagemann J, Casper I, Davis A, Becker S. Current Management of Allergic Rhinitis. THE JOURNAL OF ALLERGY AND CLINICAL IMMUNOLOGY. IN PRACTICE 2024; 12:1399-1412. [PMID: 38851250 DOI: 10.1016/j.jaip.2024.03.023] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Subscribe] [Scholar Register] [Received: 12/20/2023] [Revised: 03/08/2024] [Accepted: 03/08/2024] [Indexed: 06/10/2024]
Abstract
Allergic rhinitis (AR) is the most common allergic disease worldwide and one of the most common chronic diseases in general. Allergic rhinitis is caused by inhalant allergens from outdoor and indoor environments with varying significance of different allergens in global regions. We provide options for the current management for AR including pharmacological treatments and nonpharmacological options and allergen immunotherapy (AIT). A literature review has been conducted in Medline, Pubmed, as well as the national and international study (ClinicalTrials.gov) and guideline registers and the Cochrane Library. Human studies published on the topic in the period up to and including November 2023 were taken into account. Allergen avoidance measures, pharmacotherapy, and AIT are the cornerstones of AR treatment. Nonpharmacological measures and behavioral recommendations should be adequately added. Tools of precision medicine are already playing a significant role and will be part of the diagnostic and therapeutic standard in the future. Patients benefit most in a network of different pharmacological and nonpharmacological treatment measures including AIT. Application of precision medicine tools for diagnosis and treatment will improve standards of care.
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Affiliation(s)
- Ludger Klimek
- Center for Rhinology and Allergology, Wiesbaden, Germany.
| | - Joaquim Mullol
- Department of Otorhinolaryngology, Hospital Clínic Barcelona, FRCB-IDIBAPS, CIBERES, University of Barcelona, Barcelona, Catalonia, Spain
| | - Anne K Ellis
- Department of Medicine and Department of Biomedical and Molecular Sciences, Queen's University Kingston, Kingston, Ontario, Canada
| | | | - Jan Hagemann
- Center for Rhinology and Allergology, Wiesbaden, Germany
| | - Ingrid Casper
- Center for Rhinology and Allergology, Wiesbaden, Germany
| | - Abbie Davis
- Department of Medicine and Department of Biomedical and Molecular Sciences, Queen's University Kingston, Kingston, Ontario, Canada
| | - Sven Becker
- Department for Otorhinolaryngology, Head and Neck Surgery, University of Tuebingen, Germany
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Marth K, Renner A, Langmayr G, Pohl W, Nguyen DT, Kuhl HC. An Observational Study to Determine the Real-Life Effectiveness of MP-AzeFlu ® in Austrian Patients with Persistent Allergic Rhinitis. Drugs Real World Outcomes 2024; 11:231-240. [PMID: 38351402 PMCID: PMC11176283 DOI: 10.1007/s40801-023-00412-z] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Accepted: 12/07/2023] [Indexed: 06/15/2024] Open
Abstract
BACKGROUND Many patients with allergic rhinitis (AR) have moderate-to-severe persistent AR. Meda Pharma's AzeFlu (MP-AzeFlu®) is an intranasal AR treatment comprising a novel formulation of azelastine hydrochloride and fluticasone propionate in a single device. METHODS This prospective observational study of 214 adults and adolescents in Austria with moderate-to-severe persistent AR assessed the effectiveness of MP-AzeFlu (one spray/nostril twice daily; daily doses: azelastine hydrochloride 548 μg; and fluticasone propionate 200 μg) for AR control in clinical practice using the visual analog scale. Symptom severity was reported on days 0, 1, 3, 7, 14, 21, 28, 35, and 42. Patient demographics, AR phenotype, allergen sensitization, symptomatology, AR treatments in the previous year, and the reason for the MP-AzeFlu prescription were recorded. RESULTS MP-AzeFlu treatment was associated with a rapid and statistically significant reduction in the visual analog scale score from baseline to each timepoint measured, including day 1 (all p < 0.0001). Mean (standard deviation) visual analog scale score was 53.5 mm (26.3) at baseline, 25.3 mm (21.0) on day 28, and 19.6 mm (17.4) on day 42, a mean overall reduction from baseline of 41.4 (23.9) mm for completers. Results were consistent irrespective of patient age, gender, severity, or traditional AR phenotype. Prior to MP-AzeFlu prescription, congestion was considered the most bothersome symptom. The majority of patients reported using at least two AR therapies in the past year, including oral antihistamines, intranasal corticosteroids, and intranasal antihistamines. CONCLUSIONS Many patients in Austria live with uncontrolled persistent AR despite treatment. MP-AzeFlu provides effective and rapid control of persistent AR in a real-world Austrian setting.
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Affiliation(s)
- Katharina Marth
- Department of Pulmonology, Karl Landsteiner Institute for Experimental and Clinical Pneumology, Hietzing Hospital, 1130, Vienna, Austria.
| | - Andreas Renner
- Department of Pulmonology, Karl Landsteiner Institute for Experimental and Clinical Pneumology, Hietzing Hospital, 1130, Vienna, Austria
| | | | - Wolfgang Pohl
- Department of Pulmonology, Karl Landsteiner Institute for Experimental and Clinical Pneumology, Hietzing Hospital, 1130, Vienna, Austria
| | - Duc Tung Nguyen
- Meda Pharma GmbH & Co. KG (A Mylan Company, now Viatris), Bad Homburg, Germany
| | - Hans Christian Kuhl
- Meda Pharma GmbH & Co. KG (A Mylan Company, now Viatris), Bad Homburg, Germany
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Asadi G, Feizollahi P, Rajabinejad M, Falahi S, Rezaei Varmaziar F, Faryadi E, Gorgin Karaji A, Salari F, Rezaiemanesh A. Comparison of the efficacy of combined budesonide and fexofenadine versus combined fluticasone propionate and fexofenadine on the expression of class-4 semaphorins and their receptors in the peripheral blood cells of patients with allergic rhinitis. Heliyon 2024; 10:e22924. [PMID: 38148815 PMCID: PMC10750067 DOI: 10.1016/j.heliyon.2023.e22924] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/16/2023] [Revised: 11/18/2023] [Accepted: 11/22/2023] [Indexed: 12/28/2023] Open
Abstract
Background Allergic rhinitis (AR) is a common immunoglobulin (Ig) E-mediated disease. This study aimed to evaluate the gene expression levels of class 4 semaphorins and their receptors in AR patients before and after treatment with budesonide and fexofenadine (B/F) compared to fluticasone propionate and fexofenadine (FP/F). Methods In this study, 29 AR patients (age 34.4 ± 1.2 years, 18 men and 11 women) were treated with B/F, and 24 AR patients (age 32.8 ± 1.9 years, 15 men and 9 women) were treated with FP/F for one month. Before and after treatment, peripheral blood samples were taken from patients. The expression levels of SEMA4A, SEMA4C, SEMA4D, Plexin-B2, and Plexin-D1 genes were measured using the qPCR method. In addition, the serum levels of IgE were measured using an enzyme-linked immunosorbent assay (ELISA). Results The expression levels of SEMA4A (P = 0.011), 4C (P = 0.017), Plexin-B2 (P = 0.0005), and Plexin-D1 (P = 0.008) remarkably increased in AR patients treated with B/F. Our results show a significant reduction in the gene expression levels of SEMA4A (P = 0.002), 4C (P = 0.014), 4D (P = 0.003), Plexin-B2 (P = 0.033), and Plexin-D1 (P = 0.035) after treatment with FP/F. The serum levels of IgE increased in FP/F treated group (P = 0.017) and conversely decreased in the treated group with B/F (P = 0.019). Moreover, the percentages of eosinophils were reduced in both FP/F and B/F groups (P = 0.015 and P = 0.0001, respectively). Conclusion In conclusion, concomitant use of fexofenadine and fluticasone propionate reduced SEMA4A, 4C, 4D, Plexin-B2, and Plexin-D1, while the SEMA4A, 4C, Plexin-B2, and Plexin-D1 gene expression levels were increased in the patient group treated with B/F.
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Affiliation(s)
- Gelayol Asadi
- Student Research Committee, School of Medicine, Kermanshah University of Medical Sciences, Kermanshah, Iran
- Department of Immunology, School of Medicine, Kermanshah University of Medical Sciences, Kermanshah, Iran
| | - Parisa Feizollahi
- Department of Immunology, School of Medicine, Kermanshah University of Medical Sciences, Kermanshah, Iran
| | - Misagh Rajabinejad
- Department of Immunology, School of Medicine, Mazandaran University of Medical Sciences, Sari, Iran
- Student Research Committee, School of Medicine, Mazandaran University of Medical Sciences, Sari, Iran
| | - Sara Falahi
- Student Research Committee, School of Medicine, Kermanshah University of Medical Sciences, Kermanshah, Iran
- Department of Immunology, School of Medicine, Kermanshah University of Medical Sciences, Kermanshah, Iran
| | - Fatemeh Rezaei Varmaziar
- Student Research Committee, School of Medicine, Kermanshah University of Medical Sciences, Kermanshah, Iran
- Department of Immunology, School of Medicine, Kermanshah University of Medical Sciences, Kermanshah, Iran
| | - Elham Faryadi
- Student Research Committee, School of Medicine, Kermanshah University of Medical Sciences, Kermanshah, Iran
- Department of Immunology, School of Medicine, Kermanshah University of Medical Sciences, Kermanshah, Iran
| | - Ali Gorgin Karaji
- Department of Immunology, School of Medicine, Kermanshah University of Medical Sciences, Kermanshah, Iran
| | - Farhad Salari
- Department of Immunology, School of Medicine, Kermanshah University of Medical Sciences, Kermanshah, Iran
| | - Alireza Rezaiemanesh
- Department of Immunology, School of Medicine, Kermanshah University of Medical Sciences, Kermanshah, Iran
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Klimek L, Werminghaus P, Casper I, Cuevas M. The pharmacotherapeutic management of allergic rhinitis in people with asthma. Expert Opin Pharmacother 2024; 25:101-111. [PMID: 38281139 DOI: 10.1080/14656566.2024.2307476] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/26/2023] [Accepted: 01/16/2024] [Indexed: 01/30/2024]
Abstract
INTRODUCTION Up to 90% of asthmatic patients have comorbid allergic rhinitis (AR). Although appropriate therapy of AR can improve asthma symptoms and management, AR is often underdiagnosed and under-treated in asthmatics.A non-systematic literature research was conducted on AR as a comorbidity and risk factor of asthma. Latest international publications in medical databases, international guidelines, and the Internet were reviewed. AREAS COVERED Based on the conducted literature research there is proved evidence of the necessity of diagnosis and treatment of AR in patients with asthma because it affects health care utilization. Therefore, it is recommended in national and global guidelines. EXPERT OPINION AR increases the risk of asthma development and contributes to the severity of an existing asthma. Early treatment of AR with drugs as intranasal steroids, antihistamines, leukotriene receptor antagonists, and especially allergen-specific immunotherapy can reduce the risk of asthma development and the concomitant medication use in addition to severity of symptoms in AR and asthma.
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Affiliation(s)
- Ludger Klimek
- Center for Rhinology and Allergology Wiesbaden, Wiesbaden, Germany
| | | | - Ingrid Casper
- Center for Rhinology and Allergology Wiesbaden, Wiesbaden, Germany
| | - Mandy Cuevas
- Clinic and Policlinic of Otorhinolaryngology, Head and Neck Surgery, University Clinic Carl Gustav Carus, Technical University of Dresden, Dresden, Germany
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Hagen M, Clark K, Kalita P, Serra G, Sanchez E, Varbiro G, Albasser MM. A real-world study of quality of life following treatment with xylometazoline hydrochloride in individuals with common cold. Ther Adv Respir Dis 2024; 18:17534666241228927. [PMID: 38372128 PMCID: PMC10878222 DOI: 10.1177/17534666241228927] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/18/2023] [Accepted: 01/11/2024] [Indexed: 02/20/2024] Open
Abstract
BACKGROUND The common cold is a frequent, acute, and mild upper respiratory human disease. Nasal congestion has been considered the most bothersome symptom in the common cold, impacting quality of life (QoL). Topical decongestants containing steroids benefit QoL in allergic rhinitis, but no published research has assessed the impact of topical decongestants on QoL in the common cold. OBJECTIVE To evaluate the effects of xylometazoline hydrochloride 0.1% (Otrivin, GSK Consumer Healthcare SARL, Switzerland) for up to 7 days on QoL in participants with nasal congestion associated with the common cold. DESIGN This was a decentralized, longitudinal, open-label study. METHODS The study enrolled 136 participants (⩾18 years) with early symptoms of the common cold, of which 102 were included in the modified intention-to-treat (mITT) population. Within 24 h of study product receipt, participants confirmed a 'plugged nose' and ⩾1 other common cold symptom. Primary endpoints were Wisconsin Upper Respiratory Symptom Survey-21 (WURSS-21) total score, total and individual symptom scores, and total QoL score. Secondary endpoints were additional QoL scores. Exploratory and post hoc analyses included median days to resolution for each QoL factor and analyses of five QoL categories. RESULTS Consistent improvements in symptoms and QoL were seen in the mITT population. From day 1, improvements were seen in the 'plugged nose' symptom (p = 0.0023), WURSS-21 total QoL score, and all individual QoL scores (p < 0.0001 for all). After the last dose needed, significant improvements were seen in sleep quality (73%), vitality (76%), physical activity (71%), social activity (80%), and sensation (81%). No serious or unexpected adverse events were reported. CONCLUSION This study is the first to demonstrate in a real-life setting that treating nasal congestion in adults with xylometazoline hydrochloride 0.1% during the common cold positively impacts QoL factors relevant to daily living [Otrivin: Quality of Life (QoL) Impact in a Real-World Setting; https://clinicaltrials.gov/study/NCT05556148].
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Affiliation(s)
- Martina Hagen
- Haleon CH SARL, Route de l’Etraz 2, Nyon 1279, 1260, Switzerland
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Linton S, Hossenbaccus L, Ellis AK. Evidence-based use of antihistamines for treatment of allergic conditions. Ann Allergy Asthma Immunol 2023; 131:412-420. [PMID: 37517656 DOI: 10.1016/j.anai.2023.07.019] [Citation(s) in RCA: 13] [Impact Index Per Article: 6.5] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/08/2023] [Revised: 07/10/2023] [Accepted: 07/13/2023] [Indexed: 08/01/2023]
Abstract
Available since the 1940s, H1 antihistamines are mainstay treatments for allergic conditions such as allergic rhinitis and urticaria. They function as inverse agonists that bind to the H1 receptor to inhibit histamine-induced inflammation. The older, first-generation drugs are no longer recommended for patient use because of their well-documented negative adverse effect profile. Evidence has been accumulating to support a newer generation of H1 antihistamines in oral and intranasal formulations, including in combination with intranasal corticosteroids. The literature is replete with large meta-analyses and systematic reviews establishing the safety and efficacy of second-generation H1 antihistamines in adult and pediatric allergic rhinitis populations, including combination nasal spray agents (eg, MP29-02 or MP-AzeFlu). Although intraclass differences do exist, patient preference, access, and costs should be the priority. Robust data on the regular, not as needed use of H1 antihistamines for urticaria have been published, including in the management of children and pregnant or lactating women. In addition, H1 antihistamines can be used in other related allergic conditions, such as the secondary symptoms of anaphylaxis, to provide patients with greater comfort, including in allergic asthma, depending on the individual.
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Affiliation(s)
- Sophia Linton
- Department of Medicine, Queen's University, Kingston, Ontario, Canada; Kingston General Health Research Institute-Allergy Research Unit, Kingston, Ontario, Canada
| | - Lubnaa Hossenbaccus
- Department of Medicine, Queen's University, Kingston, Ontario, Canada; Kingston General Health Research Institute-Allergy Research Unit, Kingston, Ontario, Canada
| | - Anne K Ellis
- Department of Medicine, Queen's University, Kingston, Ontario, Canada; Kingston General Health Research Institute-Allergy Research Unit, Kingston, Ontario, Canada.
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Zhou B, Cheng L, Pan J, Wang H, Jin Y, Zhao C, Lin P, Tan G, Fang H, Zhang H, Zhou H, Dong Y, Kuhl HC, Ramalingam RK, Nguyen DT. A Clinical Study to Assess the Efficacy and Safety of MP-AzeFlu Nasal Spray in Comparison to Commercially Available Azelastine Hydrochloride and Fluticasone Propionate Nasal Sprays in Chinese Volunteers with Allergic Rhinitis. Pulm Ther 2023; 9:411-427. [PMID: 37580498 PMCID: PMC10447793 DOI: 10.1007/s41030-023-00238-8] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/25/2023] [Accepted: 07/07/2023] [Indexed: 08/16/2023] Open
Abstract
INTRODUCTION The objective of the present study was to evaluate the efficacy and safety of MP-AzeFlu nasal spray in comparison to commercially available azelastine hydrochloride and fluticasone propionate sprays in Chinese patients with moderate-to-severe allergic rhinitis (AR). METHODS We conducted a 14-day multicenter, randomized, double-blind, active controlled prospective clinical study in adult and adolescent patients with AR, who had moderate-to-severe symptoms. The primary efficacy endpoint was the change from baseline in combined 12-h reflective total nasal symptom score (rTNSS) (morning [AM] + afternoon [PM]). The safety profile of the study medications was assessed through the recording, reporting, and analysis of baseline medical conditions, adverse events (AEs), vital signs, and focused nasal examination. Three hundred patients per treatment group were randomized, which led to a total sample size estimation of 900 patients. RESULTS MP-AzeFlu group showed significantly higher symptom reduction for the entire 2-week treatment period in rTNSS when compared with the AZE group (LS mean difference: - 1.96; 95% CI: - 2.53, - 1.39; p < 0.0001), or the FLU group (LS mean difference: - 0.98; 95% CI: - 1.55, - 0.41; p = 0.0007). The results of adult RQLQ showed improvement in QoL in all treatment groups. Except for dysgeusia (bitter taste) that was reported by more patients (13 [4.3%]) in the MP-AzeFlu group, the incidence of all other TEAEs in the MP-AzeFlu group was comparable or even lower than in other treatment groups. CONCLUSIONS MP-AzeFlu, when administered as one spray per nostril twice daily for 14 days, alleviated AR symptoms in Chinese patients with moderate-to-severe AR. TRIAL REGISTRATION Clinicaltrials.gov; NCT03599791, Registered June 29, 2018, retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT03599791 .
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Affiliation(s)
- Bing Zhou
- Department of Otolaryngology Head and Neck Surgery, Beijing TongRen Hospital, Capital Medical University, Beijing, 100051, China.
| | - Lei Cheng
- Department of Otorhinolaryngology & Clinical Allergy Center, The First Affiliated Hospital, Nanjing Medical University, Nanjing, 210029, China
- International Centre for Allergy Research, Nanjing Medical University, Nanjing, 210029, China
| | - Jing Pan
- Department of Otolaryngology Head and Neck Surgery, Tianjing Renmin Hospital, Nankai University, Tianjing, China
| | - Huizhong Wang
- Department of Otolaryngology Head and Neck Surgery, Zibo Central Hospital, Zibo, China
| | - Yongde Jin
- Department of Otolaryngology Head and Neck Surgery, Yanbian University Hospital, Yanji, China
| | - Changqing Zhao
- Departments of Otolaryngology Head and Neck Surgery, Second Affiliated Hospital, Shanxi Medical University, Taiyuan, China
| | - Peng Lin
- Department of Otolaryngology Head Neck Surgery, Tianjin First Central Hospital, Tianjin Medical University, Tianjin, China
| | - Guolin Tan
- Department of Otolaryngology Head Neck Surgery, Third Xiangya Hospital, Central South University, Changsha, China
| | - Hongyan Fang
- Department of Otolaryngology Head Neck Surgery, Chongqing General Hospital, Chongqing, China
| | - Hua Zhang
- Department of Otolaryngology Head Neck Surgery, The first affiliated Hospital of Xinjiang Medical University, Wulumuqi, China
| | - Huifang Zhou
- Department of Otolaryngology Head Neck Surgery, Tianjin Medical University General Hospital, Tianjin, China
| | - Yaowu Dong
- Department of Otolaryngology Head Neck Surgery, Tonghua Central Hospital, Tonghua, China
| | - Hans Christian Kuhl
- Biometrics, MEDA Pharma GmbH & Co. KG (A Viatris Company), Bad Homburg, Germany
| | | | - Duc Tung Nguyen
- Global Clinical Sciences, MEDA Pharma GmbH & Co. KG (A Viatris Company), Bad Homburg, Germany
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Marko M, Pawliczak R. Pharmacotherapy and immunotherapy of allergic rhinitis induced by house dust mite, grass, and birch pollen allergens: a meta-analysis of randomized clinical trials. Expert Rev Respir Med 2023; 17:607-621. [PMID: 37489655 DOI: 10.1080/17476348.2023.2241364] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/06/2023] [Accepted: 07/24/2023] [Indexed: 07/26/2023]
Abstract
BACKGROUND The aim of this study was to assess the efficacy and safety of oral antihistamines (AHs), intranasal antihistamines (INAH) intranasal glucocorticosteroids (INCS), subcutaneous immunotherapy (SCIT), and sublingual immunotherapy (SLIT) in the management of allergic rhinitis (AR). The authors focused on the division into selected AR's triggers: house dust mites (HDMs), grass pollen, and birch pollen. METHODS For each drug and allergen class, a meta-analysis of the efficacy and adverse events (AEs) was performed. The obtained results were presented as a therapeutic index (TIX-Score). RESULTS Twenty-seven randomized clinical trials (RCTs) were included. The best total efficacy was observed for: HDMs for INCS and grass pollen for combination of INCS with INAH in a single device and for INAH. Considering the data that was obtained for birch pollen, SLIT showed statistically significant total efficacy. Summation scores for efficacy and AEs showed highest TIX-Score for combination of INCS and INAH in a single device in grass pollen. CONCLUSIONS Treatment methods selected for this review may serve as an effective and safe treatment in reducing perennial and seasonal AR's symptoms. However, due to high heterogeneity probably associated with potential confounders existence in control in some cases, results should be interpreted with caution.
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Affiliation(s)
- Monika Marko
- Department of Immunopathology, Faculty of Medicine, Division of Biomedical Science, Medical University of Lodz, Lodz, Poland
| | - Rafał Pawliczak
- Department of Immunopathology, Faculty of Medicine, Division of Biomedical Science, Medical University of Lodz, Lodz, Poland
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15
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Wise SK, Damask C, Roland LT, Ebert C, Levy JM, Lin S, Luong A, Rodriguez K, Sedaghat AR, Toskala E, Villwock J, Abdullah B, Akdis C, Alt JA, Ansotegui IJ, Azar A, Baroody F, Benninger MS, Bernstein J, Brook C, Campbell R, Casale T, Chaaban MR, Chew FT, Chambliss J, Cianferoni A, Custovic A, Davis EM, DelGaudio JM, Ellis AK, Flanagan C, Fokkens WJ, Franzese C, Greenhawt M, Gill A, Halderman A, Hohlfeld JM, Incorvaia C, Joe SA, Joshi S, Kuruvilla ME, Kim J, Klein AM, Krouse HJ, Kuan EC, Lang D, Larenas-Linnemann D, Laury AM, Lechner M, Lee SE, Lee VS, Loftus P, Marcus S, Marzouk H, Mattos J, McCoul E, Melen E, Mims JW, Mullol J, Nayak JV, Oppenheimer J, Orlandi RR, Phillips K, Platt M, Ramanathan M, Raymond M, Rhee CS, Reitsma S, Ryan M, Sastre J, Schlosser RJ, Schuman TA, Shaker MS, Sheikh A, Smith KA, Soyka MB, Takashima M, Tang M, Tantilipikorn P, Taw MB, Tversky J, Tyler MA, Veling MC, Wallace D, Wang DY, White A, Zhang L. International consensus statement on allergy and rhinology: Allergic rhinitis - 2023. Int Forum Allergy Rhinol 2023; 13:293-859. [PMID: 36878860 DOI: 10.1002/alr.23090] [Citation(s) in RCA: 142] [Impact Index Per Article: 71.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/09/2022] [Revised: 11/11/2022] [Accepted: 09/13/2022] [Indexed: 03/08/2023]
Abstract
BACKGROUND In the 5 years that have passed since the publication of the 2018 International Consensus Statement on Allergy and Rhinology: Allergic Rhinitis (ICAR-Allergic Rhinitis 2018), the literature has expanded substantially. The ICAR-Allergic Rhinitis 2023 update presents 144 individual topics on allergic rhinitis (AR), expanded by over 40 topics from the 2018 document. Originally presented topics from 2018 have also been reviewed and updated. The executive summary highlights key evidence-based findings and recommendation from the full document. METHODS ICAR-Allergic Rhinitis 2023 employed established evidence-based review with recommendation (EBRR) methodology to individually evaluate each topic. Stepwise iterative peer review and consensus was performed for each topic. The final document was then collated and includes the results of this work. RESULTS ICAR-Allergic Rhinitis 2023 includes 10 major content areas and 144 individual topics related to AR. For a substantial proportion of topics included, an aggregate grade of evidence is presented, which is determined by collating the levels of evidence for each available study identified in the literature. For topics in which a diagnostic or therapeutic intervention is considered, a recommendation summary is presented, which considers the aggregate grade of evidence, benefit, harm, and cost. CONCLUSION The ICAR-Allergic Rhinitis 2023 update provides a comprehensive evaluation of AR and the currently available evidence. It is this evidence that contributes to our current knowledge base and recommendations for patient evaluation and treatment.
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Affiliation(s)
- Sarah K Wise
- Otolaryngology-HNS, Emory University, Atlanta, Georgia, USA
| | - Cecelia Damask
- Otolaryngology-HNS, Private Practice, University of Central Florida, Lake Mary, Florida, USA
| | - Lauren T Roland
- Otolaryngology-HNS, Washington University, St. Louis, Missouri, USA
| | - Charles Ebert
- Otolaryngology-HNS, University of North Carolina, Chapel Hill, North Carolina, USA
| | - Joshua M Levy
- Otolaryngology-HNS, Emory University, Atlanta, Georgia, USA
| | - Sandra Lin
- Otolaryngology-HNS, University of Wisconsin, Madison, Wisconsin, USA
| | - Amber Luong
- Otolaryngology-HNS, McGovern Medical School of the University of Texas, Houston, Texas, USA
| | - Kenneth Rodriguez
- Otolaryngology-HNS, University Hospitals Cleveland Medical Center, Cleveland, Ohio, USA
| | - Ahmad R Sedaghat
- Otolaryngology-HNS, University of Cincinnati, Cincinnati, Ohio, USA
| | - Elina Toskala
- Otolaryngology-HNS, Thomas Jefferson University, Philadelphia, Pennsylvania, USA
| | | | - Baharudin Abdullah
- Otolaryngology-HNS, Universiti Sains Malaysia, Kubang, Kerian, Kelantan, Malaysia
| | - Cezmi Akdis
- Immunology, Infectious Diseases, Swiss Institute of Allergy and Asthma Research, Davos, Switzerland
| | - Jeremiah A Alt
- Otolaryngology-HNS, University of Utah, Salt Lake City, Utah, USA
| | | | - Antoine Azar
- Allergy/Immunology, Johns Hopkins University, Baltimore, Maryland, USA
| | - Fuad Baroody
- Otolaryngology-HNS, University of Chicago, Chicago, Illinois, USA
| | | | | | - Christopher Brook
- Otolaryngology-HNS, Harvard University, Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA
| | - Raewyn Campbell
- Otolaryngology-HNS, Macquarie University, Sydney, NSW, Australia
| | - Thomas Casale
- Allergy/Immunology, University of South Florida College of Medicine, Tampa, Florida, USA
| | - Mohamad R Chaaban
- Otolaryngology-HNS, Cleveland Clinic, Case Western Reserve University, Cleveland, Ohio, USA
| | - Fook Tim Chew
- Allergy/Immunology, Genetics, National University of Singapore, Singapore, Singapore
| | - Jeffrey Chambliss
- Allergy/Immunology, University of Texas Southwestern, Dallas, Texas, USA
| | - Antonella Cianferoni
- Allergy/Immunology, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, USA
| | | | | | | | - Anne K Ellis
- Allergy/Immunology, Queens University, Kingston, ON, Canada
| | | | - Wytske J Fokkens
- Otorhinolaryngology, Amsterdam University Medical Centres, Amsterdam, Netherlands
| | | | - Matthew Greenhawt
- Allergy/Immunology, Pediatrics, University of Colorado, Children's Hospital Colorado, Aurora, Colorado, USA
| | - Amarbir Gill
- Otolaryngology-HNS, University of Michigan, Ann Arbor, Michigan, USA
| | - Ashleigh Halderman
- Otolaryngology-HNS, University of Texas Southwestern, Dallas, Texas, USA
| | - Jens M Hohlfeld
- Respiratory Medicine, Fraunhofer Institute for Toxicology and Experimental Medicine ITEM, Hannover Medical School, German Center for Lung Research, Hannover, Germany
| | | | - Stephanie A Joe
- Otolaryngology-HNS, University of Illinois Chicago, Chicago, Illinois, USA
| | - Shyam Joshi
- Allergy/Immunology, Oregon Health and Science University, Portland, Oregon, USA
| | | | - Jean Kim
- Otolaryngology-HNS, Johns Hopkins University, Baltimore, Maryland, USA
| | - Adam M Klein
- Otolaryngology-HNS, Emory University, Atlanta, Georgia, USA
| | - Helene J Krouse
- Otorhinolaryngology Nursing, University of Texas Rio Grande Valley, Edinburg, Texas, USA
| | - Edward C Kuan
- Otolaryngology-HNS, University of California Irvine, Orange, California, USA
| | - David Lang
- Allergy/Immunology, Cleveland Clinic, Cleveland, Ohio, USA
| | | | | | - Matt Lechner
- Otolaryngology-HNS, University College London, Barts Health NHS Trust, London, UK
| | - Stella E Lee
- Otolaryngology-HNS, Brigham and Women's Hospital, Boston, Massachusetts, USA
| | - Victoria S Lee
- Otolaryngology-HNS, University of Illinois Chicago, Chicago, Illinois, USA
| | - Patricia Loftus
- Otolaryngology-HNS, University of California San Francisco, San Francisco, California, USA
| | - Sonya Marcus
- Otolaryngology-HNS, Stony Brook University, Stony Brook, New York, USA
| | - Haidy Marzouk
- Otolaryngology-HNS, State University of New York Upstate, Syracuse, New York, USA
| | - Jose Mattos
- Otolaryngology-HNS, University of Virginia, Charlottesville, Virginia, USA
| | - Edward McCoul
- Otolaryngology-HNS, Ochsner Clinic, New Orleans, Louisiana, USA
| | - Erik Melen
- Pediatric Allergy, Karolinska Institutet, Stockholm, Sweden
| | - James W Mims
- Otolaryngology-HNS, Wake Forest University, Winston Salem, North Carolina, USA
| | - Joaquim Mullol
- Otorhinolaryngology, Hospital Clinic Barcelona, Barcelona, Spain
| | - Jayakar V Nayak
- Otolaryngology-HNS, Stanford University, Palo Alto, California, USA
| | - John Oppenheimer
- Allergy/Immunology, Rutgers, State University of New Jersey, Newark, New Jersey, USA
| | | | - Katie Phillips
- Otolaryngology-HNS, University of Cincinnati, Cincinnati, Ohio, USA
| | - Michael Platt
- Otolaryngology-HNS, Boston University, Boston, Massachusetts, USA
| | | | | | - Chae-Seo Rhee
- Rhinology/Allergy, Seoul National University Hospital and College of Medicine, Seoul, Korea
| | - Sietze Reitsma
- Otolaryngology-HNS, University of Amsterdam, Amsterdam, Netherlands
| | - Matthew Ryan
- Otolaryngology-HNS, University of Texas Southwestern, Dallas, Texas, USA
| | - Joaquin Sastre
- Allergy, Fundacion Jiminez Diaz, University Autonoma de Madrid, Madrid, Spain
| | - Rodney J Schlosser
- Otolaryngology-HNS, Medical University of South Carolina, Charleston, South Carolina, USA
| | - Theodore A Schuman
- Otolaryngology-HNS, Virginia Commonwealth University, Richmond, Virginia, USA
| | - Marcus S Shaker
- Allergy/Immunology, Dartmouth Geisel School of Medicine, Lebanon, New Hampshire, USA
| | - Aziz Sheikh
- Primary Care, University of Edinburgh, Edinburgh, Scotland
| | - Kristine A Smith
- Otolaryngology-HNS, University of Utah, Salt Lake City, Utah, USA
| | - Michael B Soyka
- Otolaryngology-HNS, University of Zurich, University Hospital of Zurich, Zurich, Switzerland
| | - Masayoshi Takashima
- Otolaryngology-HNS, Houston Methodist Academic Institute, Houston, Texas, USA
| | - Monica Tang
- Allergy/Immunology, University of California San Francisco, San Francisco, California, USA
| | | | - Malcolm B Taw
- Integrative East-West Medicine, University of California Los Angeles, Westlake Village, California, USA
| | - Jody Tversky
- Allergy/Immunology, Johns Hopkins University, Baltimore, Maryland, USA
| | - Matthew A Tyler
- Otolaryngology-HNS, University of Minnesota, Minneapolis, Minnesota, USA
| | - Maria C Veling
- Otolaryngology-HNS, University of Texas Southwestern, Dallas, Texas, USA
| | - Dana Wallace
- Allergy/Immunology, Nova Southeastern University, Ft. Lauderdale, Florida, USA
| | - De Yun Wang
- Otolaryngology-HNS, National University of Singapore, Singapore, Singapore
| | - Andrew White
- Allergy/Immunology, Scripps Clinic, San Diego, California, USA
| | - Luo Zhang
- Otolaryngology-HNS, Beijing Tongren Hospital, Beijing, China
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A Synopsis of Guidance for Allergic Rhinitis Diagnosis and Management From ICAR 2023. THE JOURNAL OF ALLERGY AND CLINICAL IMMUNOLOGY. IN PRACTICE 2023; 11:773-796. [PMID: 36894277 DOI: 10.1016/j.jaip.2023.01.007] [Citation(s) in RCA: 15] [Impact Index Per Article: 7.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Subscribe] [Scholar Register] [Received: 12/28/2022] [Revised: 01/09/2023] [Accepted: 01/10/2023] [Indexed: 03/09/2023]
Abstract
An updated edition of the International Consensus Statement on Allergy and Rhinology: Allergic Rhinitis (ICAR:AR) has recently been published. This consensus document, which included the participation of 87 primary authors and 40 additional consultant authors, who critically appraised evidence on 144 individual topics concerning allergic rhinitis, provides guidance for health care providers using the evidence-based review with recommendations (EBRR) methodology. This synopsis highlights topical areas including pathophysiology, epidemiology, disease burden, risk and protective factors, evaluation and diagnosis, aeroallergen avoidance and environmental controls, single and combination pharmacotherapy options, allergen immunotherapy (subcutaneous, sublingual, rush, cluster), pediatric considerations, alternative and emerging therapies, and unmet needs. Based on the EBRR methodology, ICAR:AR includes strong recommendations for the treatment of allergic rhinitis: (1) for the use of newer generation antihistamines compared with first-generation alternatives, intranasal corticosteroid, intranasal saline, combination therapy with intranasal corticosteroid plus intranasal antihistamine for patients not responding to monotherapy, and subcutaneous immunotherapy and sublingual tablet immunotherapy in properly selected patients; (2) against the use of oral decongestant monotherapy and routine use of oral corticosteroids.
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17
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The add-on effect of an intranasal antihistamine with an intranasal corticosteroid in Japanese cedar pollinosis. Auris Nasus Larynx 2023; 50:81-86. [PMID: 35768286 DOI: 10.1016/j.anl.2022.05.007] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/01/2022] [Revised: 04/12/2022] [Accepted: 05/09/2022] [Indexed: 01/28/2023]
Abstract
OBJECTIVE Combination intranasal drugs with a corticosteroid and antihistamine are available in several countries with better effect than treatments with single agents. However, it remains unclear whether this effect is also seen in Japanese cedar pollinosis (JCP), the most prevalent seasonal allergic rhinitis in Japan. We investigated the effect of an add-on intranasal antihistamine with an intranasal corticosteroid in JCP during the pollen dispersal period. (UMIN000025508) METHODS: We performed a double-blinded, randomized, placebo-controlled trial from March 1 to 14, 2017. Patients (n = 20 per group) received either a mometasone furoate nasal spray (MFNS) plus a levocabastine nasal spray (levocabastine group) or MFNS plus a placebo nasal spray (placebo group). The primary endpoint was the difference in the total nasal symptom score (TNSS) after treatment between the two groups. Differences in the total ocular symptom score, total symptom score, total medication score, total symptom-medication score, and five individual symptoms as well as safety were the secondary endpoints. RESULTS The change in the TNSS from baseline was significantly greater in the levocabastine group than in the placebo group. A significant reduction in the TNSS was observed more than 6 days earlier in the levocabastine group than in the placebo group. Such add-on effects were also seen in the secondary endpoints. Both treatments were well-tolerated. CONCLUSION The intranasal antihistamine provided better control of not only nasal symptoms, but also of ocular symptoms, and decreased the need for rescue medications when added to intranasal corticosteroid treatment in JCP patients.
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18
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Yang SI, Lee IH, Kim M, Ryu G, Kang SY, Kim MA, Lee SM, Kim HJ, Park DY, Lee YJ, Kim DK, Kim SW, Kim DH, Jun YJ, Park SC, Kim BS, Chung SJ, Lee HJ, Kim HB, Choi JH, Choi GS, Yang HJ. KAAACI Allergic Rhinitis Guidelines: Part 1. Update in Pharmacotherapy. ALLERGY, ASTHMA & IMMUNOLOGY RESEARCH 2023; 15:19-31. [PMID: 36693355 PMCID: PMC9880301 DOI: 10.4168/aair.2023.15.1.19] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Subscribe] [Scholar Register] [Received: 11/07/2022] [Revised: 12/30/2022] [Accepted: 01/04/2023] [Indexed: 01/20/2023]
Abstract
The prevalence of allergic rhinitis (AR) and the socioeconomic burden associated with the medical cost and quality of life (QOL) of AR have progressively increased. Therefore, practical guidelines for the appropriate management of AR need to be developed based on scientific evidence while considering the real-world environment, values, and preferences of patients and physicians. The Korean Academy of Asthma, Allergy and Clinical Immunology revised clinical guidelines of AR to address key clinical questions of the management of AR. Part 1 of the revised guideline covers the pharmacological management of patients with AR in Korea. Through a meta-analysis and systematic review, we made 4 recommendations for AR pharmacotherapy, including intranasal corticosteroid (INCS)/intranasal antihistamine (INAH) combination therapy, oral antihistamine/INCS combination therapy, leukotriene receptor antagonist treatment in AR patients with asthma, and prophylactic treatment for patients with pollen-induced AR. However, all recommendations are conditional because of the low or very low evidence of certainty. Well-designed and strictly executed randomized controlled trials are needed to measure and report appropriate outcomes.
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Affiliation(s)
- Song-I Yang
- Department of Pediatrics, Hallym University Sacred Heart Hospital, Hallym University College of Medicine, Anyang, Korea
| | - Il Hwan Lee
- Department of Otorhinolaryngology-Head and Neck Surgery, Chuncheon Sacred Heart Hospital, Hallym University College of Medicine, Chuncheon, Korea
| | - Minji Kim
- Department of Pediatrics, Chungnam National University Sejong Hospital, Sejong, Korea
| | - Gwanghui Ryu
- Department of Otorhinolaryngology-Head and Neck Surgery, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea
| | - Sung-Yoon Kang
- Division of Pulmonology and Allergy, Department of Internal Medicine, Gil Medical Center, Gachon University College of Medicine, Incheon, Korea
| | - Mi-Ae Kim
- Department of Pulmonology, Allergy and Critical Care Medicine, CHA Bundang Medical Center, CHA University, Seongnam, Korea
| | - Sang Min Lee
- Division of Pulmonology and Allergy, Department of Internal Medicine, Gil Medical Center, Gachon University College of Medicine, Incheon, Korea
| | - Hyun-Jung Kim
- Department of Preventive Medicine, College of Medicine, Korea University, Seoul, Korea
| | - Do-Yang Park
- Department of Otolaryngology, Ajou University School of Medicine, Suwon, Korea
| | - Yong Ju Lee
- Department of Pediatrics, Yongin Severance Hospital, Yonsei University College of Medicine, Yongin, Korea
| | - Dong-Kyu Kim
- Department of Otorhinolaryngology-Head and Neck Surgery, Chuncheon Sacred Heart Hospital, Hallym University College of Medicine, Chuncheon, Korea.,Institute of New Frontier Research, Division of Big Data and Artificial Intelligence, Hallym University College of Medicine, Chuncheon, Korea
| | - Soo Whan Kim
- Department of Otolaryngology-Head and Neck Surgery, Seoul St. Mary’s Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea
| | - Do Hyun Kim
- Department of Otolaryngology-Head and Neck Surgery, Seoul St. Mary’s Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea
| | - Young Joon Jun
- Department of Otorhinolaryngology-Head and Neck surgery, Uijeongbu Eulji Medical Center, Eulji University, Uijeongbu, Korea
| | - Sang Chul Park
- Department of Otorhinolaryngology-Head and Neck surgery, Kangnam Sacred Heart Hospital, Hallym University College of Medicine, Seoul, Korea
| | - Bong-Seong Kim
- Department of Pediatrics, Gangneung Asan Hospital, University of Ulsan College of Medicine, Gangneung, Korea
| | - Soo Jie Chung
- Department of Pulmonology and Allergy, Hallym University Dongtan Sacred Heart Hospital, Hwaseong, Korea.,Allergy and Clinical Immunology Research Center, Hallym University College of Medicine, Chuncheon, Korea
| | - Hyun Jong Lee
- Lee and Hong ENT Sleep and Cosmetic Center, Seongnam, Korea
| | - Hyo-Bin Kim
- Department of Pediatrics, Asthma and Allergy Center, Inje University Sanggye Paik Hospital, Seoul, Korea
| | - Jeong-Hee Choi
- Department of Pulmonology and Allergy, Hallym University Dongtan Sacred Heart Hospital, Hwaseong, Korea.,Allergy and Clinical Immunology Research Center, Hallym University College of Medicine, Chuncheon, Korea
| | - Gil-Soon Choi
- Division of Allergy and Clinical Immunology, Department of Internal Medicine, Kosin University College of Medicine, Busan, Korea
| | - Hyeon-Jong Yang
- Department of Pediatrics, Pediatric Allergy and Respiratory Center, Soonchunhyang University College of Medicine, Seoul, Korea
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Stjärne P, Nguyen DT, Kuhl HC. Real-Life Effectiveness of MP-AzeFlu (Dymista ®) in Swedish Patients with Persistent Allergic Rhinitis, Assessed by the Visual Analogue Scale. Pragmat Obs Res 2023; 14:1-11. [PMID: 36628265 PMCID: PMC9826638 DOI: 10.2147/por.s375403] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 06/02/2022] [Accepted: 09/14/2022] [Indexed: 01/05/2023] Open
Abstract
Background Many allergic rhinitis (AR) patients have moderate/severe persistent disease. MP-AzeFlu (Dymista®) comprises intranasal azelastine hydrochloride and fluticasone propionate in a novel formulation delivered in a single device. Objective This prospective, noninterventional study assessed the effectiveness of MP-AzeFlu (one spray/nostril twice daily; azelastine hydrochloride = 548 μg; fluticasone propionate = 200 μg) on relieving AR symptom severity. Methods A visual analogue scale (VAS; 0 mm [not at all bothersome] to 100 mm [very bothersome]) was used during a 42-day MP-AzeFlu treatment period by 161 persistent AR (PER) patients in routine clinical practice in Sweden. Patients also assessed their sleep quality. Results VAS scores decreased from baseline during the treatment period and patients achieved a clinically relevant VAS score cutoff before Day 7, with 89.3% reporting well or partly controlled symptoms on Day 1. VAS score decreased from 61.4 ± 22.4 mm (baseline) to 32.1 ± 24.6 mm on Day 28 and 26.1 ± 24.3 mm on Day 42 (both p < 0.0001), an overall reduction from baseline on Day 42 of 38.1 ± 28.2 mm. The percentage of patients with very good/good sleep quality increased from 3.7%/28.6% on Day 0 to 16.5%/51.5% on Day 42. Conclusion MP-AzeFlu provides effective, rapid control of PER assessed by VAS in a real-world clinical setting in Sweden. Symptom improvement was observed at Day 1, sustained for 42 days, and associated with improved sleep quality. MP-AzeFlu significantly improved the QoL of the patients and was well tolerated.
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Affiliation(s)
- Pär Stjärne
- Department of Otorhinolaryngology, Karolinska Institute, Stockholm, Sweden,Correspondence: Pär Stjärne, Karolinska University Hospital, Department of Otorhinolaryngology, Rhinology, Stockholm, 17176, Sweden, Tel +46707250749, Fax +46 8 774 7907, Email
| | - Duc Tung Nguyen
- Global Clinical Sciences, Meda Pharma GmbH & Co. KG (A Mylan Company, Now Viatris), Bad Homburg, Germany
| | - Hans Christian Kuhl
- Global Clinical Sciences, Meda Pharma GmbH & Co. KG (A Mylan Company, Now Viatris), Bad Homburg, Germany
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20
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Vicens‐Artes S, Roca‐Ferrer J, Tubita V, Fuentes M, Alobid I, Valero A, Kopietz F, Nguyen D, Mullol J. Effect of MP-AzeFlu compared to monotherapy on COX-2, PGE 2 , and EP2 gene expression in upper airway mucosa. Immun Inflamm Dis 2023; 11:e709. [PMID: 36705401 PMCID: PMC9753815 DOI: 10.1002/iid3.709] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/06/2022] [Revised: 08/09/2022] [Accepted: 09/08/2022] [Indexed: 12/23/2022] Open
Abstract
MP-AzeFlu (intranasal fluticasone and azelastine) has been widely studied and has demonstrated efficacy in Allergic rhinitis with a superior effect compared to these drugs administered individually; however, the mechanism by which MP-AzeFlu produces this improved clinical effect has not yet been fully explained. In this study, we investigated the effect of MP-AzeFlu and fluticasone propionate (FP) on arachidonic acid metabolism as measured by changes in regulation of cyclooxygenase (COX) isoforms, prostaglandin (PG) D2 , PGE2 , PGE2 receptor (EP) 2, and EP3. Expression of these key inflammation markers was assessed through an in vitro model of upper airway inflammation using fibroblasts derived from both healthy and inflamed upper airway mucosa. Both MP-AzeFlu and FP inhibited interleukin-1β-induced COX-2 messenger RNA (mRNA) and protein expression and PGE2 secretion in vitro. MP-AzeFlu and FP both upregulated EP2 mRNA expression, though neither upregulated EP2 protein expression. This downregulation of COX-2 and PGE2 coupled with upregulation of EP2 receptor expression reinforces the anti-inflammatory effect of MP-AzeFlu in upper airway inflammation.
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Affiliation(s)
- Sonia Vicens‐Artes
- Clinical and Experimental Respiratory Immunoallergy, IDIBAPSBarcelonaSpain
| | - Jordi Roca‐Ferrer
- Clinical and Experimental Respiratory Immunoallergy, IDIBAPSBarcelonaSpain
- CIBER of Respiratory Diseases (CIBERES)BarcelonaSpain
| | - Valeria Tubita
- Clinical and Experimental Respiratory Immunoallergy, IDIBAPSBarcelonaSpain
- Clinical and Experimental Respiratory ImmunoallergyUniversitat de BarcelonaBarcelonaSpain
| | - Mireya Fuentes
- Clinical and Experimental Respiratory Immunoallergy, IDIBAPSBarcelonaSpain
- CIBER of Respiratory Diseases (CIBERES)BarcelonaSpain
| | - Isam Alobid
- Clinical and Experimental Respiratory Immunoallergy, IDIBAPSBarcelonaSpain
- CIBER of Respiratory Diseases (CIBERES)BarcelonaSpain
- Clinical and Experimental Respiratory ImmunoallergyUniversitat de BarcelonaBarcelonaSpain
- Rhinology Unit & Smell Clinic, ENT DepartmentHospital Clinic BarcelonaBarcelonaSpain
| | - Antonio Valero
- Clinical and Experimental Respiratory Immunoallergy, IDIBAPSBarcelonaSpain
- CIBER of Respiratory Diseases (CIBERES)BarcelonaSpain
- Allergy SectionPulmonology & Allergy DepartmentBarcelonaSpain
| | | | - DucTung Nguyen
- MEDA Pharma GmbH & Co. KG (A Viatris Company)Bad HomburgGermany
| | - Joaquim Mullol
- Clinical and Experimental Respiratory Immunoallergy, IDIBAPSBarcelonaSpain
- CIBER of Respiratory Diseases (CIBERES)BarcelonaSpain
- Clinical and Experimental Respiratory ImmunoallergyUniversitat de BarcelonaBarcelonaSpain
- Rhinology Unit & Smell Clinic, ENT DepartmentHospital Clinic BarcelonaBarcelonaSpain
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21
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Pharmakotherapie bei allergischer Rhinitis und Asthma bronchiale. ALLERGO JOURNAL 2022. [DOI: 10.1007/s15007-022-5060-5] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/27/2022]
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22
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Chitsuthipakorn W, Hoang MP, Kanjanawasee D, Seresirikachorn K, Snidvongs K. Combined medical therapy in the treatment of allergic rhinitis: Systematic review and meta-analyses. Int Forum Allergy Rhinol 2022; 12:1480-1502. [PMID: 35446512 DOI: 10.1002/alr.23015] [Citation(s) in RCA: 4] [Impact Index Per Article: 1.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/21/2021] [Revised: 03/05/2022] [Accepted: 04/17/2022] [Indexed: 12/19/2022]
Abstract
BACKGROUND Antihistamines (ATH) and intranasal corticosteroids (INCS) are primary treatments for patients with allergic rhinitis (AR). When monotherapy of either primary treatment fails to control symptoms, combined medical therapy is an option. In this meta-analysis we assessed the additional effects of different medical combinations compared with primary treatments. METHODS Systematic searches on PubMed and EMBASE were updated on November 4, 2021. Randomized, controlled trials comparing the effects of combinations with monotherapy were included. There were 7 comparisons: (1) ATH-decongestant vs ATH; (2) ATH-leukotriene receptor antagonist (LTRA) vs ATH; (3) INCS-ATH vs INCS; (4) INCS-LTRA vs INCS; (5) INCS-decongestion vs INCS; (6) INCS-saline irrigation vs INCS; and (7) ATH-saline irrigation vs ATH. Data were pooled for meta-analysis. Outcomes were composite nasal symptom score, composite ocular symptom score, quality of life (QoL), and adverse events. RESULTS Fifty-three studies were included. Compared with ATH alone, the ATH-decongestant combination improved composite nasal symptoms; ATH-LTRA improved nasal symptoms in patients with perennial AR; and ATH-nasal saline improved both symptoms and QoL. Compared with INCS alone, the INCS-intranasal ATH combination improved nasal symptoms, ocular symptoms, and QoL; INCS-LTRA improved ocular symptoms but not nasal symptoms; and INCS-nasal saline improved QoL but not symptoms. There were no additional effects observed from adding oral ATH or topical decongestant to INCS. CONCLUSION After ATH monotherapy fails to control symptoms, addition of decongestant, saline, or LTRA can improve the outcomes. When INCS monotherapy is ineffective, addition of intranasal ATH can improve nasal symptoms; LTRA can improve ocular symptoms, and saline irrigation can improve QoL.
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Affiliation(s)
- Wirach Chitsuthipakorn
- Center of Excellence in Otolaryngology, Head and Neck Surgery, Rajavithi Hospital, Bangkok, Thailand.,College of Medicine, Rangsit University, Bangkok, Thailand
| | - Minh P Hoang
- Department of Otolaryngology, Hue University of Medicine and Pharmacy, Hue University, Hue, Vietnam.,Department of Otolaryngology, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.,Endoscopic Nasal and Sinus Surgery Excellence Center, King Chulalongkorn Memorial Hospital, Bangkok, Thailand
| | - Dichapong Kanjanawasee
- Center of Research Excellence in Allergy and Immunology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.,Biodesign Innovation Center, Department of Parasitology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand
| | - Kachorn Seresirikachorn
- Department of Otolaryngology, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.,Endoscopic Nasal and Sinus Surgery Excellence Center, King Chulalongkorn Memorial Hospital, Bangkok, Thailand
| | - Kornkiat Snidvongs
- Department of Otolaryngology, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.,Endoscopic Nasal and Sinus Surgery Excellence Center, King Chulalongkorn Memorial Hospital, Bangkok, Thailand
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23
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Watts AM, West NP, Smith PK, Zhang P, Cripps AW, Cox AJ. Nasal immune gene expression in response to azelastine and fluticasone propionate combination or monotherapy. Immun Inflamm Dis 2022; 10:e571. [PMID: 34813682 PMCID: PMC8926499 DOI: 10.1002/iid3.571] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/14/2021] [Revised: 10/28/2021] [Accepted: 11/13/2021] [Indexed: 11/30/2022] Open
Abstract
BACKGROUND The combination of the antihistamine azelastine (AZE) with the corticosteroid fluticasone propionate (FP) in a single spray, has been reported to be significantly more effective at reducing allergic rhinitis (AR) symptoms than treatment with either corticosteroid or antihistamine monotherapy. However, the biological basis for enhanced symptom relief is not known. This study aimed to compare gene expression profiles (760 immune genes, performed with the NanoString nCounter) from peripheral blood and nasal brushing/lavage lysate samples in response to nasal spray treatment. METHODS Moderate/severe persistent dust mite AR sufferers received either AZE (125 μg/spray) nasal spray (n = 16), FP (50 μg/spray) nasal spray (n = 14) or combination spray AZE/FP (125 μg AZE and 50 μg FP/spray) (n = 14) for 7 days, twice daily. Self-reported symptom questionnaires were completed daily for the study duration. Gene expression analysis (760 immune genes) was performed with the NanoString nCounter on purified RNA from peripheral blood and nasal brushing/lavage lysate samples. RESULTS In nasal samples, 206 genes were significantly differentially expressed following FP treatment; 182 genes downregulated (-2.57 to -0.45 Log2 fold change [FC]), 24 genes upregulated (0.49-1.40 Log2 FC). In response to AZE/FP, only 16 genes were significantly differentially expressed; 10 genes downregulated (-1.53 to -0.58 Log2 FC), six genes upregulated (1.07-1.62 Log2 FC). Following AZE treatment only five genes were significantly differentially expressed; one gene downregulated (-1.68 Log2 FC), four genes upregulated (0.59-1.19 Log2 FC). Immune gene changes in peripheral blood samples following treatment were minimal. AR symptoms improved under all treatments, but improvements were less pronounced following AZE treatment. CONCLUSION AZE/FP, FP, and AZE had diverse effects on immune gene expression profiles in nasal mucosa samples. The moderate number of genes modulated by AZE/FP indicates alternative pathways in reducing AR symptoms whilst avoiding extensive local immune suppression.
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Affiliation(s)
- Annabelle M. Watts
- School of Medical ScienceGriffith UniversitySouthportQueenslandAustralia
| | - Nicholas P. West
- School of Medical ScienceGriffith UniversitySouthportQueenslandAustralia
- Menzies Health Institute of QueenslandGriffith UniversitySouthportQueenslandAustralia
| | - Peter K. Smith
- Queensland Allergy Services ClinicSouthportQueenslandAustralia
| | - Ping Zhang
- Menzies Health Institute of QueenslandGriffith UniversitySouthportQueenslandAustralia
| | - Allan W. Cripps
- Menzies Health Institute of QueenslandGriffith UniversitySouthportQueenslandAustralia
- School of MedicineGriffith UniversitySouthportQueenslandAustralia
| | - Amanda J. Cox
- School of Medical ScienceGriffith UniversitySouthportQueenslandAustralia
- Menzies Health Institute of QueenslandGriffith UniversitySouthportQueenslandAustralia
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24
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Liu Z, Zhang L, Chen W, Yuan F, Yang Z, Liu S, Le F. miR-195-5p regulates cell proliferation, apoptosis, and invasion of thyroid cancer by targeting telomerase reverse transcriptase. Bioengineered 2021; 12:6201-6209. [PMID: 34482792 PMCID: PMC8806884 DOI: 10.1080/21655979.2021.1963908] [Citation(s) in RCA: 14] [Impact Index Per Article: 3.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 02/09/2023] Open
Abstract
In most human primary cancers, the expression, or telomerase activity, of telomerase reverse transcriptase (TERT) is detectable. However, the mechanism ofTERTactivity within oncogenesis of thyroid cancer remains largely unknown. In this study, we identified miR-195-5p as having involvement in cell proliferation, apoptosis, and invasion in human thyroid cancer. MTT was used to measure cell proliferation, Transwell chamber was used to measure invasion. Western blotting was used to detect the expressions of TERT, PCNA, and Ki67. Target gene prediction software predicted that TERT may be the target gene of miR-195-5p. Luciferase reporting system was used to identify the targeting relationship. A significant increase of in TERT expression was observed by immunohistochemistry compared with normal tissue, however, a decrease in miR-195-5p expression using qRT-PCRand western blot compared with normal cells. Functional analysis demonstrates that miR-195-5p negatively correlated withTERTand inhibitedTERTexpression through its interaction with theTERT3ʹ-untranslatedregion (3ʹ-UTR). Overexpression of miR-195-5p was shown to inhibit proliferation and invasion, and promote apoptosis of CAL-62 thyroid cancer cells. miR-195-5p-mediatedeffects were rescued by the overexpression ofTERT. Altogether, our data demonstrate that miR-195-5p regulates cell proliferation, apoptosis, and invasion in human thyroid cancer viaTERT, providing evidence of a new potential therapeutic target for further investigation.
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Affiliation(s)
- Zhiwen Liu
- Department Of Neonatal Surgery, Jiangxi Provincial Children's Hospital, Nanchang, Jiangxi, China
| | - Li Zhang
- Electrocardiography Room, Jiangxi Provincial Cancer Hospital, Jiangxi Cancer Hospital of Nanchang University ,Jiangxi Provincial Key Laboratory of Translational Medicine and Oncology ,Jiangxi Cancer Center, Nanchang, Jiangxi, China
| | - Wen Chen
- Department Of Breast Surgery, Jiangxi Provincial Cancer Hospital, Jiangxi Cancer Hospital of Nanchang University, Jiangxi Provincial Key Laboratory of Translational Medicine and Oncology, Jiangxi Cancer Center, Nanchang, Jiangxi, China
| | - Fenqian Yuan
- Department Of Head And Neck Surgery, Jiangxi Provincial Cancer Hospital, Jiangxi Cancer Hospital of Nanchang University, Jiangxi Provincial Key Laboratory of Translational Medicine and Oncology, Jiangxi Cancer Center, Nanchang, Jiangxi, China
| | - Zhi Yang
- Department Of Neonatal Surgery, Jiangxi Provincial Children's Hospital, Nanchang, Jiangxi, China
| | - Sheng Liu
- Department Of Thoracic Surgery, The First Affiliated Hospital of Nanchang University, Nanchang, Jiangxi, China
| | - Fei Le
- Department Of Head And Neck Surgery, Jiangxi Provincial Cancer Hospital, Jiangxi Cancer Hospital of Nanchang University, Jiangxi Provincial Key Laboratory of Translational Medicine and Oncology, Jiangxi Cancer Center, Nanchang, Jiangxi, China
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Clinical efficacy and safety of MP-AzeFlu for the treatment of allergic rhinitis: a meta-analysis. Eur Arch Otorhinolaryngol 2021; 279:2457-2464. [PMID: 34415405 DOI: 10.1007/s00405-021-07048-1] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/21/2021] [Accepted: 08/15/2021] [Indexed: 10/20/2022]
Abstract
OBJECTIVE MP-AzeFlu is a novel option for therapy of allergic rhinitis (AR). The purpose of our study was to assess the safety and efficacy of MP-AzeFlu for the treatment of allergic rhinitis, compared to placebo and azelastine monotherapy. METHODS The PubMed, MEDLINE, EMBASE and Cochrane databases were comprehensively searched for all published randomized controlled trials (RCTs) of using MP-AzeFlu nasal spray on July 26, 2019. In these studies, we selected patients with clinical symptom scores. The heterogeneity of the included studies was assessed by I2. RESULTS Among the 336 citations retrieved, 6 articles with over 6000 patients were finally included in the meta-analysis. The results of meta-analysis revealed that MP-AzeFlu was superior to placebo ( - 2.43 [95%CI, - 2.73 to - 2.14], P < 0.00001) and azelastine ( - 1.27 [95% CI, - 1.57 to - 0.97], P < 0.00001) in reflective total nasal symptom score. In the MP-AzeFlu group, the instantaneous total nasal symptom score ( - 2.56 [95% CI, - 3.02 to - 2.10], P < 0.00001) and the reflective total ocular symptom score ( - 1.22 [95% CI, - 1.57 to - 0.87], P < 0.00001) were significantly reduced compared to the placebo group. CONCLUSION MP-AzeFlu is as safe and mild as placebo and azelastine, which also is associated with symptom relief and the improvement of quality of life in AR patients. MP-AzeFlu can provide better clinical benefits than two currently available first-line intranasal therapies. It is an ideal therapy for AR patients.
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Yum HY, Ha EK, Shin YH, Han MY. Prevalence, comorbidities, diagnosis, and treatment of nonallergic rhinitis: real-world comparison with allergic rhinitis. Clin Exp Pediatr 2021; 64:373-383. [PMID: 32777916 PMCID: PMC8342874 DOI: 10.3345/cep.2020.00822] [Citation(s) in RCA: 11] [Impact Index Per Article: 2.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/04/2020] [Revised: 06/15/2020] [Accepted: 07/27/2020] [Indexed: 12/17/2022] Open
Abstract
Rhinitis is among the most common respiratory diseases in children. Nonallergic rhinitis, which involves nasal symptoms without evidence of systemic allergic inflammation or infection, is a heterogeneous entity with diverse manifestations and intensities. Nonallergic rhinitis accounts for 16%-89% of the chronic rhinitis cases, affecting 1%-50% (median 10%) of the total pediatric population. The clinical course of nonallergic rhinitis is generally rather mild and less likely to be associated with allergic comorbidities than allergic rhinitis. Here, we aimed to estimate the rate of coexisting comorbidities of nonallergic rhinitis. Nonallergic rhinitis is more prevalent during the first 2 years of life; however, its underestimation for children with atopic tendencies is likely due to low positive rates of specific allergic tests during early childhood. Local allergic rhinitis is a recently noted phenotype with rates similar to those in adults (median, 44%; range, 4%-67%), among patients previously diagnosed with nonallergic rhinitis. Idiopathic rhinitis, a subtype of nonallergic rhinitis, has been poorly studied in children, and its rates are known to be lower than those in adults. The prevalence of nonallergic rhinitis with eosinophilia syndrome is even lower. A correlation between nonallergic rhinitis and pollution has been suggested owing to the recent increase in nonallergic rhinitis rates in highly developing regions such as some Asian countries, but many aspects remain unknown. Conventional treatments include antihistamines, intranasal corticosteroids, and recent treatments include combination of intranasal corticosteroids with azelastin or decongestants. Here we review the prevalence, diagnosis, comorbidities, and treatment recommendations for nonallergic rhinitis versus allergic rhinitis in children.
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Affiliation(s)
- Hye Yung Yum
- Department of Pediatrics, Seoul Medical Center, Seoul, Korea
| | - Eun Kyo Ha
- Department of Pediatrics, Kangnam Sacred Heart Hospital, Hallym University College of Medicine, Seoul, Korea
| | - Yoon Ho Shin
- Department of Pediatrics, CHA Gangnam Medical Center, CHA University School of Medicine, Seoul, Korea
| | - Man Yong Han
- Department of Pediatrics, CHA Bundang Medical Center, CHA University School of Medicine, Seongnam, Korea
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The Effectiveness of the Bacteria Derived Extremolyte Ectoine for the Treatment of Allergic Rhinitis. BIOMED RESEARCH INTERNATIONAL 2021; 2021:5562623. [PMID: 34159193 PMCID: PMC8187048 DOI: 10.1155/2021/5562623] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Subscribe] [Scholar Register] [Received: 01/28/2021] [Accepted: 05/20/2021] [Indexed: 11/24/2022]
Abstract
Nonpharmacological therapies with a good tolerability and safety profile are of interest to many patients with allergic rhinitis, as a relevant proportion of them have reservations about guideline-concordant pharmacological therapies due to their local irritations and side effects. Ectoine is a bacterial-derived extremolyte with an ability to protect proteins and biological membranes against damage caused by extreme conditions of salinity, drought, irradiation, pH, and temperature. Evidence from preclinical and clinical studies attests its effectiveness in the treatment of several inflammatory diseases, including allergic rhinitis. In this review, we analyzed 14 recent clinical trials investigating ectoine nasal spray in patients with allergic rhinitis and/or conjunctivitis, including sensitive patient groups like children or pregnant women. Some studies investigated monotherapy with ectoine; others investigated combination therapy of ectoine and an antihistamine or a corticosteroid. Analysis of the study results demonstrated that patients with mild-to-moderate symptoms of allergic rhinitis can be successfully treated with ectoine-containing nasal spray. When applied as monotherapy, ectoine exerted noninferior effects compared to first-line therapies such as antihistamines and cromoglicic acid. Using ectoine as an add-on therapy to antihistamines or intranasal glucocorticosteroids accelerated symptom relief by days and improved the level of symptom relief. Importantly, concomitant treatment with ectoine was proven beneficial in a group of difficult-to-treat patients suffering from moderate-to-severe rhinitis symptoms. Taken together, the natural substance ectoine represents a viable alternative for allergic rhinitis and conjunctivitis patients who wish to avoid local reactions and side effects associated with pharmacological therapies.
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Ahsanuddin S, Povolotskiy R, Tayyab R, Nasser W, Barinsky GL, Grube JG, Paskhover B. Adverse Events Associated with Intranasal Sprays: An Analysis of the Food and Drug Administration Database and Literature Review. Ann Otol Rhinol Laryngol 2021; 130:1292-1301. [PMID: 33813873 DOI: 10.1177/00034894211007222] [Citation(s) in RCA: 4] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/16/2022]
Abstract
BACKGROUND Intranasal sprays (INSs) are commonly used medications for the treatment of many rhinologic conditions. Despite their popularity, an analysis of a nationwide reporting database and comparison to the available literature has never been performed. METHODS The Food and Drug Administration Adverse Event Reporting System (FAERS) database was accessed to obtain adverse event (AE) records from 2014 to 2019 for varying INSs, including: 10 corticosteroids, 1 alpha adrenergic, and 3 antihistamines. The Proportional Reporting Ratios (PRR) and Reporting Odds Ratios (ROR) were calculated for dyspnea, anosmia, ageusia/dysgeusia, epistaxis, and headache. A PRR ≥ 2 or ROR ≥ 1 was considered significant. RESULTS Corticosteroids had 98 864 total reported AEs to the database, followed by antihistamines (7011) and alpha adrenergics (2071). In total, dyspnea was reported 5843 times, followed by headache (4230), epistaxis (1205), ageusia/dysgeusia (920), and anosmia (312). Overall, PRR and ROR values for dyspnea ranged from 0.51 to 4.25 and 0.51 to 4.49; for dysgeusia/ageusia from 0.56 to 6.09 and 0.56 to 6.12; and for epistaxis from 1.03 to 27.24 and 1.03 to 30.76, respectively. All medications which listed anosmia within the top AEs had PRR and ROR values exceeding 2 and 1, respectively. The PRR for headache exceeded 2 for 1 medication and the ROR exceeded 1 in 7 medications. CONCLUSION The AEs of dyspnea, anosmia, ageusia/dysgeusia, epistaxis, and headache are reported within the FAERS database for commonly prescribed INSs. When compared against the existing scientific literature, the clinical significance of this reporting tool from the FDA for these classes of medications remains unvalidated.
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Affiliation(s)
- Salma Ahsanuddin
- Department of Otolaryngology-Head and Neck Surgery, Rutgers New Jersey Medical School, Newark, NJ, USA
| | - Roman Povolotskiy
- Department of Otolaryngology-Head and Neck Surgery, Rutgers New Jersey Medical School, Newark, NJ, USA
| | - Rahma Tayyab
- Department of Otolaryngology-Head and Neck Surgery, Rutgers New Jersey Medical School, Newark, NJ, USA
| | - Wissam Nasser
- Department of Otolaryngology-Head and Neck Surgery, Rutgers New Jersey Medical School, Newark, NJ, USA
| | - Gregory L Barinsky
- Department of Otolaryngology-Head and Neck Surgery, Rutgers New Jersey Medical School, Newark, NJ, USA
| | - Jordon G Grube
- Department of Surgery, Division of Otolaryngology/Head and Neck Surgery, Albany Medical Center, Albany, NJ, USA
| | - Boris Paskhover
- Department of Otolaryngology-Head and Neck Surgery, Rutgers New Jersey Medical School, Newark, NJ, USA.,Department of Facial Plastics and Reconstructive Surgery, Rutgers New Jersey Medical School, Newark, NJ, USA
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AeDA überarbeitet Dokumentationsbogen. ALLERGO JOURNAL 2021. [DOI: 10.1007/s15007-021-4780-2] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/26/2022]
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Fowler J, Rotenberg BW, Sowerby LJ. The subtle nuances of intranasal corticosteroids. J Otolaryngol Head Neck Surg 2021; 50:18. [PMID: 33731223 PMCID: PMC7968222 DOI: 10.1186/s40463-020-00480-z] [Citation(s) in RCA: 9] [Impact Index Per Article: 2.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/03/2020] [Accepted: 11/16/2020] [Indexed: 01/31/2024] Open
Abstract
Background In the specialty of Otolaryngology – Head and Neck Surgery, intranasal corticosteroids are the mainstay treatment for inflammatory processes within the nasal cavity. All too often, physician prescribing patterns are based on previous training, personal experience, and interactions with industry. The purpose of this commentary is to review the nuances of each intranasal corticosteroid. Commentary There are nine intranasal corticosteroids approved for use in Canada. Each are discussed in detail, including their indication, bioavailability, effects on intranasal environment, and factors around patient adherence. Off-label use of budesonide irrigations is also discussed and cost information is presented in reference format for all available intranasal corticosteroids. Conclusion Although the efficacy of each intranasal corticosteroid has been shown to be similar, prescribing should be tailored based on bioavailability, intranasal environment, and factors that impact patient adherence such as dosing, cost and tolerability. Graphical abstract ![]()
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Affiliation(s)
- James Fowler
- Department of Otolaryngology - Head and Neck Surgery, Western University, 3St. Joseph's Hospital, 268 Grosvenor Street, London, ON, N6A 4V2, Canada
| | - Brian W Rotenberg
- Department of Otolaryngology - Head and Neck Surgery, Western University, 3St. Joseph's Hospital, 268 Grosvenor Street, London, ON, N6A 4V2, Canada
| | - Leigh J Sowerby
- Department of Otolaryngology - Head and Neck Surgery, Western University, 3St. Joseph's Hospital, 268 Grosvenor Street, London, ON, N6A 4V2, Canada.
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van Weissenbruch R, Klimek L, Gálffy G, Emmeluth M, Koltun A, Kopietz F, Nguyen DT, Kuhl HC, Pohl W, Scadding GK, Price D, Mullol J. MP-AzeFlu Improves the Quality-of-Life of Patients with Allergic Rhinitis. J Asthma Allergy 2020; 13:633-645. [PMID: 33293835 PMCID: PMC7719305 DOI: 10.2147/jaa.s277734] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Abstract] [Key Words] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/29/2020] [Accepted: 10/29/2020] [Indexed: 11/23/2022] Open
Abstract
Purpose Patients with poorly controlled allergic rhinitis (AR) experience nasal symptoms, sleep disturbances, activity impairment, and decreased quality-of-life (QoL). MP-AzeFlu is safe and effective for moderate-to-severe seasonal and perennial AR, but its impact on QoL requires investigation in the real-world, especially among phenotypes of immunoglobulin (Ig)E-mediated AR. This subanalysis of an observational study evaluated response to MP-AzeFlu via assessment of sleep quality and trouble with daily activities. Patients and Methods This multicenter, prospective, non-interventional, real-life study included a convenience sample of patients with a history of moderate-to-severe AR presenting with acute AR symptoms (visual analog scale [VAS] ≥50 mm). Over approximately 14 days of treatment with MP-AzeFlu (137 µg azelastine HCL and 50 µg fluticasone propionate administered via single 0.137-mL spray in each nostril twice daily), changes in sleep quality and trouble with daily work, school, social, and outdoor activities were evaluated using a VAS for the entire study population and for four subgroups based on IgE response phenotype. VAS scores ranged from “not at all troubled” (0 mm) to “extremely troubled” (100 mm). Results Following MP-AzeFlu treatment, mean VAS scores for sleep quality impairment and work or school impairment decreased from 55.2 mm at baseline to 22.1 mm and 57.6 mm at baseline to 23.0 mm, respectively, after ~14 days. Similar results were observed for mean VAS scores for impairment of social activity (55.1 mm to 22.4 mm) and impairment of outdoor activity (64.4 mm to 25.0 mm). For all VAS scores, results were similar across populations, regardless of phenotype of IgE-mediated disease, comorbidity, age, and sex. Conclusion MP-AzeFlu relieves symptoms and improves patient-reported QoL, illustrated by better sleep quality and less impairment of work, school, social, and outdoor activities after 14 days. The QoL benefits of MP-AzeFlu were consistent regardless of the phenotype of IgE-mediated disease. Registration Clinical Trial Registration (CTR) Number: EUPAS23075. Trial Register Date: March 12, 2018. First patient visit; Last patient visit: February 2018; April 2019.
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Affiliation(s)
| | - Ludger Klimek
- Department of Otorhinolaryngology and Head and Neck Plastic Surgery, Zentrum für Rhinologie und Allergologie, Wiesbaden, Germany
| | | | - Melanie Emmeluth
- Global Medical Affairs, MEDA Pharma GmbH & Co. KG (A Mylan Company), Bad Homburg, Germany
| | | | - Ferdinand Kopietz
- Global Medical Affairs, MEDA Pharma GmbH & Co. KG (A Mylan Company), Bad Homburg, Germany
| | - Duc Tung Nguyen
- GBK Clinical Affairs, MEDA Pharma GmbH & Co. KG (A Mylan Company), Bad Homburg, Germany
| | - Hans Christian Kuhl
- Global Medical Affairs, MEDA Pharma GmbH & Co. KG (A Mylan Company), Bad Homburg, Germany
| | - Wolfgang Pohl
- Department of Respiratory and Pulmonary Diseases, Karl Landsteiner Gesellschaft, Institute of Clinical and Experimental Pneumology, Vienna, Austria
| | | | - David Price
- Centre of Academic Primary Care, Division of Applied Health Sciences, University of Aberdeen, Aberdeen, UK.,Observational and Pragmatic Research Institute, Singapore, Singapore
| | - Joaquim Mullol
- Rhinology Unit & Smell Clinic, ENT Department, Hospital Clinic Barcelona IDIBAPS University of Barcelona, CIBERES, Barcelona, Catalonia, Spain
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Passalacqua G, Musarra A, Senna G, Bousquet J, Ferrara C, Lonati C, Canonica GW. Physicians' prescribing behaviour and clinical practice patterns for allergic rhinitis management in Italy. Clin Mol Allergy 2020; 18:20. [PMID: 33292294 PMCID: PMC7640419 DOI: 10.1186/s12948-020-00135-4] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/11/2020] [Accepted: 09/16/2020] [Indexed: 12/19/2022] Open
Abstract
BACKGROUND Despite availability of clinical guidelines, underdiagnosis, undertreatment, and poor adherence are still significant concerns in allergic rhinitis (AR) therapeutic management. We investigated clinical practice patterns and prescribing behavior of Italian healthcare professionals (HCPs) specialized in AR. METHODS One-hundred allergologists, 100 ear, nose and throat (ENT) specialists, and 150 general practitioners (GPs) were recruited. The survey assessed: socio-demographic, work experience, monthly caseload, prescription drivers. Next, HCPs were invited to retrospectively recover patients' clinical data to investigate: AR clinical characteristics, therapy management, prescription patterns, patient adherence. Descriptive statistics, Chi square, One-Way analysis of variance, and Two-Way Analysis of Variance were performed. RESULTS Allergologists visited more AR patients (31% of monthly caseload) than ENTs (21%, p < 0.001), while GPs' caseload was the lowest (6%). Clinical information of 2823 patients were retrieved of whom 1906 (67.5%) suffered from moderate/severe AR (discomfort score: 7.7 ± 1.3) and 917 (32.4%) from mild AR (5.7 ± 1.9). About one-third of mild patients had a discomfort score ≥ 7. Main prescription drivers were "effective on all symptoms" (54.3% patients) and "quick symptom relief" (47.8%), whereas minor drivers were "affordable price" (13.4%) and "refundable" (8.7%). The most prescribed drugs were antihistamines and intranasal corticosteroids (79% and 55% prescriptions), followed by fixed-dose-combination of intranasal azelastine/fluticasone (19%). Polytherapy was the most common treatment strategy (59.6%). HCPs' believe that the majority of the patients was adherent to treatment (88% with score > 7). CONCLUSIONS This survey describes the therapeutic approach adopted by Italian physicians to cope with AR and shows that HCPs underestimated AR severity and had a non-realistic perception of patients' adherence. These findings suggest that further efforts are required to improve AR clinical management in Italy.
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Affiliation(s)
- Giovanni Passalacqua
- Allergy and Respiratory Diseases, IRCCS Policlinico San Martino, University of Genoa, Genoa, Italy
| | - Antonino Musarra
- Allergy Unit, National Healthcare System, Scilla, Reggio Calabria, Italy
| | - Gianenrico Senna
- Unità Operativa di Allergologia-Asma Center-Azienda Ospedaliera, Universitaria Integrata di Verona, Verona, Italy
| | - Jean Bousquet
- Comprehensive Allergy Center, Department of Dermatology and Allergy, Charité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany
- Centre Hospitalier Universitaire de Montpellier, Montpellier, France
- MACVIA-France, Montpellier, France
| | | | - Caterina Lonati
- Center for Preclinical Research, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, via Pace 9, 20122, Milan, Italy.
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Du K, Qing H, Zheng M, Wang X, Zhang L. Intranasal antihistamine is superior to oral H 1 antihistamine as an add-on therapy to intranasal corticosteroid for treating allergic rhinitis. Ann Allergy Asthma Immunol 2020; 125:589-596.e3. [PMID: 32650045 DOI: 10.1016/j.anai.2020.06.038] [Citation(s) in RCA: 13] [Impact Index Per Article: 2.6] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/16/2020] [Revised: 06/12/2020] [Accepted: 06/24/2020] [Indexed: 01/20/2023]
Abstract
BACKGROUND Currently, a combination of intranasal corticosteroid (INCS) plus oral H1 antihistamine (OAH) or intranasal H1 antihistamine (INAH) therapy is frequently used in the treatment of allergic rhinitis (AR). The superiority of the 2 combined treatments needs to be further examined. OBJECTIVE To identify the better of the 2 therapeutic strategies for treating AR. METHODS A literature review was performed on MEDLINE, Cochrane Library, and EMBASE databases. Following the guidelines of the Preferred Reporting Items for Systematic Reviews and Meta-analyses, meta-analyses of the total nasal symptom scores and individual nasal symptom scores were pooled based on studies that compared concomitant H1 antihistamines plus INCS with INCS alone in the treatment of AR. The pooled results were expressed as weighted mean differences between the treatments. For each selected study, we calculated the relative clinical impact based on the total nasal symptom scores as follows: 100 × (ScoreMonotherapy - ScoreCombined therapy) / ScoreMonotherapy. RESULTS A total of 13 publications met our selection criteria, with 5066 patients. The pooled results revealed no significant weighted mean difference on the total nasal symptom scores between concomitant OAH plus INCS and INCS alone. As for the individual symptoms, the most common symptom that revealed remission was rhinorrhea, which was after OAH in combination with INCS. The combination therapy of INAH and INCS was superior to INCS alone. In an indirect comparison, the weighted mean relative clinical impact of INAH plus INCS was significantly higher than that of OAH plus INCS. CONCLUSION Intranasal H1 antihistamines have an add-on effect on intranasal corticosteroids, and the combination of intranasal H1 antihistamines plus intranasal corticosteroid is superior to that of oral H1 antihistamines plus intranasal corticosteroid in improving nasal symptoms for patients with AR.
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Affiliation(s)
- Kun Du
- Department of Otorhinolaryngology Head and Neck Surgery, Beijing Tongren Hospital, Key Laboratory of Otolaryngology Head and Neck Surgery, Capital Medical University, Ministry of Education, Beijing, People's Republic of China
| | - Hui Qing
- Department of Allergy, Beijing Tongren Hospital, Capital Medical University, Beijing, People's Republic of China
| | - Ming Zheng
- Department of Otorhinolaryngology Head and Neck Surgery, Beijing Tongren Hospital, Key Laboratory of Otolaryngology Head and Neck Surgery, Capital Medical University, Ministry of Education, Beijing, People's Republic of China
| | - Xiangdong Wang
- Department of Otorhinolaryngology Head and Neck Surgery, Beijing Tongren Hospital, Key Laboratory of Otolaryngology Head and Neck Surgery, Capital Medical University, Ministry of Education, Beijing, People's Republic of China; Beijing Key Laboratory of Nasal Diseases, Beijing Institute of Otolaryngology, Beijing, People's Republic of China.
| | - Luo Zhang
- Department of Otorhinolaryngology Head and Neck Surgery, Beijing Tongren Hospital, Key Laboratory of Otolaryngology Head and Neck Surgery, Capital Medical University, Ministry of Education, Beijing, People's Republic of China; Department of Allergy, Beijing Tongren Hospital, Capital Medical University, Beijing, People's Republic of China; Beijing Key Laboratory of Nasal Diseases, Beijing Institute of Otolaryngology, Beijing, People's Republic of China.
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Liu X, Wang DY, Charn TC, Koh LT, Teo NW, Ong YK, Thong MK, Bachert C, Pfaar O, Schünemann HJ, Bedbrook A, Czarlewski W, Bousquet J. Next-Generation Allergic Rhinitis Care in Singapore: 2019 ARIA Care Pathways. ANNALS OF THE ACADEMY OF MEDICINE, SINGAPORE 2020; 49:885-896. [PMID: 33381782 DOI: 10.47102/annals-acadmedsg.202076] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 06/12/2023]
Abstract
Allergic rhinitis (AR) is prevalent in Singapore, with a significant disease burden. Afflicting up to 13% of the population, AR impairs quality of life, leads to reduced work productivity and is an independent risk factor for asthma. In the last 2 decades, local studies have identified patient and physician behaviours leading to suboptimal control of the disease. Yet, there is an overall lack of attention to address this important health issue. Allergic Rhinitis and its Impact on Asthma (ARIA) is a European organisation aimed at implementing evidence-based management for AR worldwide. Recent focus in Europe has been directed towards empowering patients for self-management, exploring the complementary role of mobile health, and establishing healthcare system-based integrated care pathways. Consolidation of these ongoing efforts has led to the release of the 2019 ARIA care pathways. This review summarises the ARIA update with particular emphasis on the current status of adult AR in Singapore. In addition, we identify unmet needs and future opportunities for research and clinical care of AR in the local context.
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Affiliation(s)
- Xuandao Liu
- Department of Otolaryngology, Head and Neck Surgery, Sengkang General Hospital, Singapore
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Klimek L, Casper I, Bergmann KC, Biedermann T, Bousquet J, Hellings P, Jung K, Merk H, Olze H, Mösges R, Schlenter W, Gröger M, Ring J, Chaker A, Pfaar O, Wehrmann W, Zuberbier T, Becker S. Die Therapie der allergischen Rhinitis in der Routineversorgung: evidenzbasierte Nutzenbewertung der kombinierten Anwendung mehrerer Wirkstoffe. ALLERGO JOURNAL 2020. [DOI: 10.1007/s15007-020-2551-0] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 10/23/2022]
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Dykewicz MS, Wallace DV, Amrol DJ, Baroody FM, Bernstein JA, Craig TJ, Dinakar C, Ellis AK, Finegold I, Golden DBK, Greenhawt MJ, Hagan JB, Horner CC, Khan DA, Lang DM, Larenas-Linnemann DES, Lieberman JA, Meltzer EO, Oppenheimer JJ, Rank MA, Shaker MS, Shaw JL, Steven GC, Stukus DR, Wang J, Dykewicz MS, Wallace DV, Dinakar C, Ellis AK, Golden DBK, Greenhawt MJ, Horner CC, Khan DA, Lang DM, Lieberman JA, Oppenheimer JJ, Rank MA, Shaker MS, Stukus DR, Wang J, Dykewicz MS, Wallace DV, Amrol DJ, Baroody FM, Bernstein JA, Craig TJ, Finegold I, Hagan JB, Larenas-Linnemann DES, Meltzer EO, Shaw JL, Steven GC. Rhinitis 2020: A practice parameter update. J Allergy Clin Immunol 2020; 146:721-767. [PMID: 32707227 DOI: 10.1016/j.jaci.2020.07.007] [Citation(s) in RCA: 175] [Impact Index Per Article: 35.0] [Reference Citation Analysis] [Abstract] [Key Words] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/06/2020] [Revised: 06/22/2020] [Accepted: 07/01/2020] [Indexed: 12/12/2022]
Abstract
This comprehensive practice parameter for allergic rhinitis (AR) and nonallergic rhinitis (NAR) provides updated guidance on diagnosis, assessment, selection of monotherapy and combination pharmacologic options, and allergen immunotherapy for AR. Newer information about local AR is reviewed. Cough is emphasized as a common symptom in both AR and NAR. Food allergy testing is not recommended in the routine evaluation of rhinitis. Intranasal corticosteroids (INCS) remain the preferred monotherapy for persistent AR, but additional studies support the additive benefit of combination treatment with INCS and intranasal antihistamines in both AR and NAR. Either intranasal antihistamines or INCS may be offered as first-line monotherapy for NAR. Montelukast should only be used for AR if there has been an inadequate response or intolerance to alternative therapies. Depot parenteral corticosteroids are not recommended for treatment of AR due to potential risks. While intranasal decongestants generally should be limited to short-term use to prevent rebound congestion, in limited circumstances, patients receiving regimens that include an INCS may be offered, in addition, an intranasal decongestant for up to 4 weeks. Neither acupuncture nor herbal products have adequate studies to support their use for AR. Oral decongestants should be avoided during the first trimester of pregnancy. Recommendations for use of subcutaneous and sublingual tablet allergen immunotherapy in AR are provided. Algorithms based on a combination of evidence and expert opinion are provided to guide in the selection of pharmacologic options for intermittent and persistent AR and NAR.
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Affiliation(s)
- Mark S Dykewicz
- Section of Allergy and Immunology, Division of Infectious Diseases, Allergy and Immunology, Department of Internal Medicine, School of Medicine, Saint Louis University, St Louis, Mo.
| | - Dana V Wallace
- Department of Medicine, Nova Southeastern Allopathic Medical School, Fort Lauderdale, Fla
| | - David J Amrol
- Department of Internal Medicine, School of Medicine, University of South Carolina, Columbia, SC
| | - Fuad M Baroody
- Department of Otolaryngology-Head and Neck Surgery, Pritzker School of Medicine, University of Chicago, Chicago, Ill
| | - Jonathan A Bernstein
- Allergy Section, Division of Immunology, Department of Internal Medicine, College of Medicine, University of Cincinnati, Cincinnati, Ohio
| | - Timothy J Craig
- Departments of Medicine and Pediatrics, Penn State University, Hershey, Pa
| | - Chitra Dinakar
- Division of Pulmonary, Allergy and Critical Care Medicine, Department of Medicine, School of Medicine, Stanford University, Stanford, Calif
| | - Anne K Ellis
- Division of Allergy and Immunology, Department of Medicine, Queen's University, Kingston, Ontario, Canada
| | - Ira Finegold
- Division of Allergy and Immunology, Department of Medicine, Mount Sinai West, New York, NY
| | - David B K Golden
- Division of Allergy and Clinical Immunology, Department of Medicine, School of Medicine, John Hopkins University, Baltimore, Md
| | - Matthew J Greenhawt
- Section of Allergy and Immunology, Department of Pediatrics, Children's Hospital Colorado, School of Medicine, University of Colorado, Aurora, Colo
| | - John B Hagan
- Division of Allergic Diseases, Mayo Clinic, Rochester, Minn
| | - Caroline C Horner
- Division of Allergy, Immunology and Pulmonary Medicine, Department of Pediatrics, School of Medicine, Washington University, St Louis, Mo
| | - David A Khan
- Division of Allergy and Immunology, Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas, Tex
| | - David M Lang
- Department of Allergy and Clinical Immunology, Respiratory Institute, Cleveland Clinic Lerner College of Medicine at Case Western Reserve University, Cleveland, Ohio
| | | | - Jay A Lieberman
- Division of Pulmonology Allergy and Immunology, Department of Pediatrics, The University of Tennessee Health Science Center, Memphis, Tenn
| | - Eli O Meltzer
- Division of Allergy and Immunology, Department of Pediatrics, School of Medicine, University of California, San Diego, Calif; Allergy and Asthma Medical Group and Research Center, San Diego, Calif
| | - John J Oppenheimer
- Division of Pulmonary & Critical Care Medicine and Allergic & Immunologic Diseases, Department of Internal Medicine, University of Medicine and Dentistry of New Jersey-Rutgers New Jersey Medical School, New Brunswick, NJ; Pulmonary and Allergy Associates, Morristown, NJ
| | - Matthew A Rank
- Division of Allergy, Asthma, and Clinical Immunology, Mayo Clinic in Arizona, Scottsdale, Ariz
| | - Marcus S Shaker
- Department of Pediatrics, Dartmouth-Hitchcock Medical Center, Lebanon, NH
| | | | | | - David R Stukus
- Division of Allergy and Immunology, Nationwide Children's Hospital, Columbus, Ohio; Department of Pediatrics, College of Medicine, The Ohio State University, Columbus, Ohio
| | - Julie Wang
- Division of Allergy and Immunology, Department of Pediatrics, The Elliot and Roslyn Jaffe Food Allergy Institute, Icahn School of Medicine at Mount Sinai, New York, NY
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Zieglmayer P, Schmutz R, Lemell P, Unger-Manhart N, Nakowitsch S, Goessl A, Savli M, Zieglmayer R, Prieschl-Grassauer E. Fast effectiveness of a solubilized low-dose budesonide nasal spray in allergic rhinitis. Clin Exp Allergy 2020; 50:1065-1077. [PMID: 32569395 PMCID: PMC7540702 DOI: 10.1111/cea.13691] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [Key Words] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/01/2020] [Revised: 06/09/2020] [Accepted: 06/14/2020] [Indexed: 12/12/2022]
Abstract
Background Budesonide, a poorly water‐soluble corticosteroid, is currently marketed as a suspension. Budesolv is a novel aqueous formulation containing dissolved budesonide showing increased local availability in preclinical models. Budesolv contains ~85% less corticosteroid than the marketed comparator. Objective The study (EudraCT:2018‐001324‐19) was designed to assess non‐inferiority of Budesolv compared to Rhinocort® Aqua 64 (RA) and early onset of action. Methods In a three‐way cross‐over double‐blinded randomized trial, Budesolv 10 was compared to RA and placebo in grass pollen allergic rhinoconjunctivitis volunteers (n = 83 (ITT); n = 75 (PP)). On day 1, participants entered the Vienna Challenge Chamber (VCC) for 6 hours; first treatment took place at 1:45 hours after entry. Participants treated themselves for further 6 days; on day 8, the last treatment was applied before entering the VCC. Subjective symptom scores, nasal airflow and nasal secretion were measured regularly during allergen challenge. Results Budesolv 10 was equally effective compared to RA with respect to TNSS and nasal airflow after eight days of treatment with a strongly reduced dose (more than 80% reduction). After first dose, only Budesolv 10 showed a significant reduction of nasal and respiratory symptoms starting 90 minutes (P < .05) and 15 minutes (P < .05) after application onwards, respectively, demonstrating an early onset of efficacy. A clinically significant 1 point reduction in nasal symptom score was reached at 195 minutes (P < .05) after application. Conclusions and clinical relevance The novel preservative‐free, aqueous low‐dose budesonide formulation is highly efficacious even after an initial single treatment. Thus, Budesolv 10 appears to be an effective acute treatment for allergic rhinitis as well as for AR comorbidities like mild asthma and conjunctivitis.
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Affiliation(s)
- Petra Zieglmayer
- Power Project GmbH, Vienna Challenge Chamber, Vienna, Austria.,Medical University, Vienna, Austria
| | - René Schmutz
- Power Project GmbH, Vienna Challenge Chamber, Vienna, Austria.,Medical School, Sigmund Freud University, Vienna, Austria
| | - Patrick Lemell
- Power Project GmbH, Vienna Challenge Chamber, Vienna, Austria
| | | | | | | | | | - René Zieglmayer
- Power Project GmbH, Vienna Challenge Chamber, Vienna, Austria
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Berger WE, Bachert C, Allara R, Koltun A, Kopietz F, Maus JG, D'Addio AD. Evaluation of in vitro Penetration of Fluticasone Propionate from MP-AzeFlu and Fluticasone Propionate Nasal Spray Through EpiAirway™606 Tissues Using Vertical Diffusion Cells. J Asthma Allergy 2020; 13:187-192. [PMID: 32547111 PMCID: PMC7266522 DOI: 10.2147/jaa.s238421] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [Abstract] [Key Words] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/23/2022] Open
Abstract
Purpose Most patients with allergic rhinitis (AR) have moderate-to-severe disease, requiring complete and prompt relief when symptoms occur. The time course of fluticasone propionate (FP) penetration into nasal tissues after intranasal administration is not well characterized. The goal of this proof-of-concept study was to evaluate the mucosal penetration of FP from fixed-combination FP-azelastine nasal spray (MP-AzeFlu) compared with an FP-only nasal spray in an in vitro, 3-dimensional human bronchial tissue model. Materials and Methods Absorption of FP from MP-AzeFlu and FP nasal spray was modeled using EpiAirway™606 (MatTek Corporation; Ashland, MA, USA) tissue cultured in vertical diffusion cells. The dosing amount of MP-AzeFlu was optimized in a pilot study. Based on the results of the pilot study, 10 µL of MP-AzeFlu (3.65 µg; n = 8) and 10 µL of FP nasal spray (5.00 µg; n = 8) were evaluated for penetration of tissue. Tissue integrity was monitored with Lucifer yellow. FP in the receiving media was quantified for each sample using liquid chromatography with tandem mass spectrometry. Results MP-AzeFlu and FP nasal spray were associated with similar FP accumulation profiles in the receiving media, but the permeability of FP was greater for MP-AzeFlu during hours 0 to 6, suggesting faster absorption for MP-AzeFlu. No indications of compromised tissue integrity were found in any of the tested cells. Conclusion The higher and more rapid penetration of FP from MP-AzeFlu supports the use of MP-AzeFlu for patients with AR, particularly when prioritizing fast and pronounced symptom relief.
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Affiliation(s)
- William E Berger
- Allergy and Asthma Associates of Southern California, Mission Viejo, CA, USA
| | | | | | | | | | - Joachim G Maus
- Meda Pharma GmbH & Co. KG (a Mylan Company), Bad Homburg, Germany
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Hossenbaccus L, Linton S, Garvey S, Ellis AK. Towards definitive management of allergic rhinitis: best use of new and established therapies. ALLERGY, ASTHMA, AND CLINICAL IMMUNOLOGY : OFFICIAL JOURNAL OF THE CANADIAN SOCIETY OF ALLERGY AND CLINICAL IMMUNOLOGY 2020; 16:39. [PMID: 32508939 PMCID: PMC7251701 DOI: 10.1186/s13223-020-00436-y] [Citation(s) in RCA: 24] [Impact Index Per Article: 4.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Subscribe] [Scholar Register] [Received: 01/22/2020] [Accepted: 05/13/2020] [Indexed: 12/18/2022]
Abstract
BACKGROUND Allergic rhinitis (AR) is an inflammatory disease of the nasal mucosa impacting up to 25% of Canadians. The standard of care for AR includes a treatment plan that takes into account patient preferences, the severity of the disease, and most essentially involves a shared decision-making process between patient and provider. BODY Since their introduction in the 1940s, antihistamines (AHs) have been the most utilized class of medications for the treatment of AR. First-generation AHs are associated with adverse central nervous system (CNS) and anticholinergic side effects. On the market in the 1980s, newer generation AHs have improved safety and efficacy. Compared to antihistamines, intranasal corticosteroids (INCS) have significantly greater efficacy but longer onset of action. Intranasal AH and INCS combinations offer a single medication option that offers broader disease coverage and faster symptom control. However, cost and twice-per-day dosing remain a major limitation. Allergen immunotherapy (AIT) is the only disease-modifying option and can be provided through subcutaneous (SCIT) or sublingual (SLIT) routes. While SCIT has been the definitive management option for many years, SLIT tablets (SLIT-T) have also been proven to be safe and efficacious. CONCLUSION There is a range of available treatment options for AR that reflect the varying disease length and severity. For mild to moderate AR, newer generation AHs should be the first-line treatment, while INCS are mainstay treatments for moderate to severe AR. In patients who do not respond to INCS, a combination of intranasal AH/INCS (AZE/FP) should be considered, assuming that cost is not a limiting factor. While SCIT remains the option with the most available allergens that can be targeted, it has the potential for severe systemic adverse effects and requires weekly visits for administration during the first 4 to 6 months. SLIT-T is a newer approach that provides the ease of being self-administered and presents a reduced risk for systemic reactions. In any case, standard care for AR includes a treatment plan that takes into account disease severity and patient preferences.
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Affiliation(s)
- Lubnaa Hossenbaccus
- Department of Biomedical and Molecular Sciences, Queen’s University, Kingston, Canada
- Allergy Research Unit, Kingston General Health Research Institute, Kingston, Canada
| | - Sophia Linton
- Department of Medicine, Queen’s University, Kingston, Canada
- Allergy Research Unit, Kingston General Health Research Institute, Kingston, Canada
| | - Sarah Garvey
- Allergy Research Unit, Kingston General Health Research Institute, Kingston, Canada
| | - Anne K. Ellis
- Department of Biomedical and Molecular Sciences, Queen’s University, Kingston, Canada
- Department of Medicine, Queen’s University, Kingston, Canada
- Allergy Research Unit, Kingston General Health Research Institute, Kingston, Canada
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Yorgancıoğlu AA, Gemicioğlu B, Cingi C, Kalaycı Ö, Kalyoncu AF, Bachert C, Hellings P, Pfaar O, Schünemann HJ, Wallace D, Bedbrook A, Czarlewski W, Bousquet J. ARIA 2019, Allerjik Rinite Tedavi Yaklaşımı-Türkiye. Turk Thorac J 2020; 21:122-133. [PMID: 32203003 DOI: 10.5152/turkthoracj.2019.19084] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/11/2019] [Accepted: 08/06/2019] [Indexed: 11/22/2022]
Abstract
Gerçek yaşamda, çevresel maruziyetlerin de etkilediği rinit ve astım mültimorbidite durumlarında, dijitalleşmiş ve kişiye odaklanan tedaviler için bütünleştirilmiş tedavi yollarının değerlendirilmesi önerilmektedir. Gerçek yaşamdaki bu durum mültisipliner bir yaklaşımla basamaklandırılıp, rehberilerinde ülkelerdeki gereksinimlere göre değiştilmesini gerektirebilir. Allerjik rinitte hem farmakoterapi hem immünoterapi açısından acil yeni yaklaşımlara ihtiyaç olduğu görülmüştür. 3. Aralık 2018'de Paris'te bir toplantı yapılmış ve iki ayrı belge hazırlanmıştır. Bu yayında bunlara ait bir özet sunulup, ülkeye ve sağlık sistemine uygun kullanımın çerçevesi oluşturulmak istenmiştir.
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Affiliation(s)
| | - Bilun Gemicioğlu
- Department of Chest Diseases, İstanbul University-Cerrahpaşa, Cerrahpasa School of Medicine, İstanbul, Turkey
| | - Cemal Cingi
- Department of Ear Nose Throat, Eskişehir Osmangazi University School of Medicine, Eskişehir, Turkey
| | - Ömer Kalaycı
- Department of Pediatric Allergy, Hacettepe University School of Medicine, Ankara, Turkey
| | - Ali Fuat Kalyoncu
- Department of Chest Diseases, Hacettepe University School of Medicine, Ankara, Turkey
| | - Claus Bachert
- Upper Airways Research Laboratory, ENT Dept, Ghent University Hospital, Ghent, Belgium
| | - Peter Hellings
- Department of Otorhinolaryngology, University Hospitals Leuven, Belgium, and Academic Medical Center, University of Amsterdam, The Netherlands and Euforea, Brussels, Belgium
| | - Oliver Pfaar
- Department of Otorhinolaryngology, Head and Neck Surgery, Section of Rhinology and Allergy, University Hospital Marburg, Phillipps-Universität Marburg, Germany
| | - Holger J Schünemann
- Department of Health Research Methods, Evidence, and Impact, Division of Immunology and Allergy, McMaster University, Hamilton, ON, Canada
| | - Dana Wallace
- Nova Southeastern University, Fort Lauderdale, Florida, USA
| | - Anna Bedbrook
- MACVIA-France, Fondation partenariale FMC VIA-LR, Montpellier, France
| | | | - Jean Bousquet
- MACVIA-France, Fondation partenariale FMC VIA-LR, Montpellier, France
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ARIA guideline 2019: treatment of allergic rhinitis in the German health system. Allergol Select 2019; 3:22-50. [PMID: 32176226 PMCID: PMC7066682 DOI: 10.5414/alx02120e] [Citation(s) in RCA: 57] [Impact Index Per Article: 9.5] [Reference Citation Analysis] [Abstract] [Key Words] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/23/2019] [Accepted: 11/04/2019] [Indexed: 12/14/2022] Open
Abstract
Background: The number of patients affected by allergies is increasing worldwide. The resulting allergic diseases are leading to significant costs for health care and social systems. Integrated care pathways are needed to enable comprehensive care within the national health systems. The ARIA (Allergic Rhinitis and its Impact on Asthma) initiative develops internationally applicable guidelines for allergic respiratory diseases. Methods: ARIA serves to improve the care of patients with allergies and chronic respiratory diseases. In collaboration with other international initiatives, national associations and patient organizations in the field of allergies and respiratory diseases, real-life integrated care pathways have been developed for a digitally assisted, integrative, individualized treatment of allergic rhinitis (AR) with comorbid asthma. In the present work, these integrated care pathways have been adapted to the German situation and health system. Results: The present ICP (integrated care pathway) guideline covers key areas of the care of AR patients with and without asthma. It includes the views of patients and other healthcare providers. Discussion: A comprehensive ICP guideline can reflect real-life care better than traditional guideline models.
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Shao Z, Bernstein JA. Occupational Rhinitis: Classification, Diagnosis, and Therapeutics. Curr Allergy Asthma Rep 2019; 19:54. [PMID: 31776689 DOI: 10.1007/s11882-019-0892-0] [Citation(s) in RCA: 5] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 01/13/2023]
Abstract
PURPOSE OF REVIEW Occupational rhinitis (OR), an inflammatory disease of the nose, refers to any nasal symptoms reported to be work-related. The purpose of this review is to provide a current overview of the classification, diagnosis, and treatment of OR. RECENT FINDINGS Occupational rhinitis (OR) can further be classified into allergic or non-allergic depending on the causative agent(s) and pathogenesis. Presenting symptoms are similar to non-OR including nasal congestion, anterior and posterior rhinorrhea, sneezing, and nasal itching. Despite its high prevalence in a spectrum of workplaces, OR is under reported as it is often considered a nuisance rather than a potential precursor to occupational asthma (OA). The diagnosis of OR is obfuscated as it is difficult to determine if this condition was caused by environmental determinants in or outside the workplace. Furthermore, workers may have a pre-existing history of allergic or non-allergic rhinitis leading the clinician and worker to overlook inciting agents in the workplace. In this case, a diagnosis of OR is still possible depending on the exposures but must be differentiated from work-exacerbated rhinitis. Further complicating the diagnosis of OR is the lack of evidence-based research focused on this condition as it is often trivialized due to the perception that it has an insignificant impact on the worker's health. The reality is that OR can have a significant impact on the worker's quality of life and is associated with a number of comorbidities including occupational asthma, recurrent sinusitis, headaches, eustachian tube dysfunction, and sleep disorders similar to non-occupational rhinitis. However, one significant difference between these disorders is that workers diagnosed with OR are eligible for worker's compensation. Treatment of OR involves avoidance of the inciting agent(s) and medications similar to those used to treat non-OR conditions. This review summarizes recent progresses on the etiology, risk factors, diagnosis, and therapy of OR. In addition, suggested areas of further research with potential targets for modifications in the workplace environment as well as therapeutic interventions will be discussed.
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Affiliation(s)
- Zhisheng Shao
- School of Podiatric Medicine, Temple University, Philadelphia, PA, 19107, USA
| | - Jonathan A Bernstein
- Bernstein Allergy Group, 8444 Winton Road, Cincinnati, OH, 45231, USA.
- Division of Immunology, Allergy and Rheumatology, Department of Internal Medicine, University of Cincinnati, 231 Albert Sabin Way, ML0563, Cincinnati, OH, 45267, USA.
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Klimek L. Die Dokumentation ist entscheidend. ALLERGO JOURNAL 2019. [DOI: 10.1007/s15007-019-1961-3] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 10/25/2022]
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Bousquet J, Pfaar O, Togias A, Schünemann HJ, Ansotegui I, Papadopoulos NG, Tsiligianni I, Agache I, Anto JM, Bachert C, Bedbrook A, Bergmann K, Bosnic‐Anticevich S, Bosse I, Brozek J, Calderon MA, Canonica GW, Caraballo L, Cardona V, Casale T, Cecchi L, Chu D, Costa E, Cruz AA, Czarlewski W, Durham SR, Du Toit G, Dykewicz M, Ebisawa M, Fauquert JL, Fernandez‐Rivas M, Fokkens WJ, Fonseca J, Fontaine J, Gerth van Wijk R, Haahtela T, Halken S, Hellings PW, Ierodiakonou D, Iinuma T, Ivancevich JC, Jacobsen L, Jutel M, Kaidashev I, Khaitov M, Kalayci O, Kleine Tebbe J, Klimek L, Kowalski ML, Kuna P, Kvedariene V, La Grutta S, Larenas‐Linemann D, Lau S, Laune D, Le L, Lodrup Carlsen K, Lourenço O, Malling H, Marien G, Menditto E, Mercier G, Mullol J, Muraro A, O’Hehir R, Okamoto Y, Pajno GB, Park H, Panzner P, Passalacqua G, Pham‐Thi N, Roberts G, Pawankar R, Rolland C, Rosario N, Ryan D, Samolinski B, Sanchez‐Borges M, Scadding G, Shamji MH, Sheikh A, Sturm GJ, Todo Bom A, Toppila‐Salmi S, Valentin‐Rostan M, Valiulis A, Valovirta E, Ventura M, Wahn U, Walker S, Wallace D, Waserman S, Yorgancioglu A, Zuberbier T. 2019 ARIA Care pathways for allergen immunotherapy. Allergy 2019; 74:2087-2102. [PMID: 30955224 DOI: 10.1111/all.13805] [Citation(s) in RCA: 113] [Impact Index Per Article: 18.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/22/2019] [Revised: 02/19/2019] [Accepted: 02/22/2019] [Indexed: 01/02/2023]
Abstract
Allergen immunotherapy (AIT) is a proven therapeutic option for the treatment of allergic rhinitis and/or asthma. Many guidelines or national practice guidelines have been produced but the evidence-based method varies, many are complex and none propose care pathways. This paper reviews care pathways for AIT using strict criteria and provides simple recommendations that can be used by all stakeholders including healthcare professionals. The decision to prescribe AIT for the patient should be individualized and based on the relevance of the allergens, the persistence of symptoms despite appropriate medications according to guidelines as well as the availability of good-quality and efficacious extracts. Allergen extracts cannot be regarded as generics. Immunotherapy is selected by specialists for stratified patients. There are no currently available validated biomarkers that can predict AIT success. In adolescents and adults, AIT should be reserved for patients with moderate/severe rhinitis or for those with moderate asthma who, despite appropriate pharmacotherapy and adherence, continue to exhibit exacerbations that appear to be related to allergen exposure, except in some specific cases. Immunotherapy may be even more advantageous in patients with multimorbidity. In children, AIT may prevent asthma onset in patients with rhinitis. mHealth tools are promising for the stratification and follow-up of patients.
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Affiliation(s)
- Jean Bousquet
- MACVIA‐France, Fondation partenariale FMC VIA‐LR Montpellier France
- INSERM U 1168, VIMA : Ageing and Chronic Diseases Epidemiological and Public Health Approaches Villejuif France
- UMR‐S 1168 Université Versailles St‐Quentin‐en‐Yvelines Montigny le Bretonneux France
- Euforea Brussels Belgium
- Charité‐Universitätsmedizin Berlin, Humboldt‐Universität zu Berlin Berlin Germany
| | - Oliver Pfaar
- Department of Otorhinolaryngology, Head and Neck Surgery, Section of Rhinology and Allergy, University Hospital Marburg Philipps‐Universität Marburg Marburg Germany
| | - Alkis Togias
- Division of Allergy, Immunology, and Transplantation (DAIT) National Institute of Allergy and Infectious Diseases, NIH Bethesda Maryland
| | - Holger J. Schünemann
- Department of Health Research Methods, Evidence and Impact, Division of Immunology and Allergy McMaster University Hamilton Ontario Canada
| | | | - Nikolaos G. Papadopoulos
- Division of Infection, Immunity & Respiratory Medicine, Royal Manchester Children's Hospital University of Manchester Manchester UK
- Allergy Department, 2nd Pediatric Clinic, Athens General Children's Hospital "P&A Kyriakou” University of Athens Athens Greece
| | - Ioanna Tsiligianni
- Department of Social Medicine, Faculty of Medicine University of Crete and International Primary Care Respiratory Group Crete Greece
| | - Ioana Agache
- Faculty of Medicine Transylvania University Brasov Romania
| | - Josep M. Anto
- Centre for Research in Environmental Epidemiology (CREAL) ISGlobAL Barcelona Spain
- IMIM (Hospital del Mar Research Institute) Barcelona Spain
- Universitat Pompeu Fabra (UPF) Barcelona Spain
- CIBER Epidemiología y Salud Pública (CIBERESP) Barcelona Spain
| | - Claus Bachert
- ENT Department, Upper Airways Research Laboratory Ghent University Hospital Ghent Belgium
| | - Anna Bedbrook
- MACVIA‐France, Fondation partenariale FMC VIA‐LR Montpellier France
| | - Karl‐Christian Bergmann
- Department of Dermatology and Allergy Charité ‐ Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Berlin Institute of Health, Comprehensive Allergy Centre, Member of GALEN, Humboldt‐Uniersität zu Berlin Berlin Germany
| | - Sinthia Bosnic‐Anticevich
- Woolcock Institute of Medical Research, Woolcock Emphysema Centre and Local Health District University of Sydney Glebe New South Wales Australia
| | | | - Jan Brozek
- Department of Health Research Methods, Evidence and Impact, Division of Immunology and Allergy McMaster University Hamilton Ontario Canada
| | - Moises A. Calderon
- Imperial College London ‐ National Heart and Lung Institute Royal Brompton Hospital NHS London UK
| | - Giorgio W. Canonica
- Personalized Medicine Clinic Asthma & Allergy, Humanitas Research Hospital Humanitas University Milan Italy
| | - Luigi Caraballo
- Institute for Immunological Research University of Cartagena, Campus de Zaragocilla Cartagena Colombia
- Foundation for the Development of Medical and Biological Sciences (Fundemeb) Cartagena Colombia
| | - Victoria Cardona
- Allergy Section, Department of Internal Medicine Hospital Vall d'Hebron & ARADyAL Research Network Barcelona Spain
| | - Thomas Casale
- Division of Allergy/Immunology University of South Florida Tampa Florida
| | - Lorenzo Cecchi
- SOS Allergology and Clinical Immunology USL Toscana Centro Prato Italy
| | - Derek Chu
- Department of Health Research Methods, Evidence and Impact, Division of Immunology and Allergy McMaster University Hamilton Ontario Canada
| | - Elisio Costa
- UCIBIO, REQUIMTE, Faculty of Pharmacy, and Competence Center on Active and Healthy Ageing of University of Porto (AgeUPNetWork) University of Porto Porto Portugal
| | - Alvaro A. Cruz
- ProAR – Nucleo de Excelencia em Asma Federal University of Bahia Salvador Brazil
- WHO GARD Planning Group Salvador Brazil
| | | | - Stephen R. Durham
- Allergy and Clinical Immunology Section, National Heart and Lung Institute Imperial College London London UK
| | - George Du Toit
- Guy's and st Thomas' NHS Trust, Kings College London London UK
| | - Mark Dykewicz
- Section of Allergy and Immunology Saint Louis University School of Medicine Saint Louis Missouri
| | - Motohiro Ebisawa
- Clinical Research Center for Allergy and Rheumatology Sagamihara National Hospital Sagamihara Japan
| | - Jean Luc Fauquert
- Unité de pneumo‐allergologie de l'enfant, pôle pédiatrique CHU de Clermont‐Ferrand‐Estaing Clermont‐Ferrand France
| | | | - Wytske J. Fokkens
- Department of Otorhinolaryngology Academic Medical Centres Amsterdam The Netherlands
| | - João Fonseca
- CINTESIS, Center for Research in Health Technology and Information Systems Faculdade de Medicina da Universidade do Porto Porto Portugal
- Medida, Lda Porto Portugal
| | | | - Roy Gerth van Wijk
- Department of Internal Medicine, Section of Allergology Erasmus MC Rotterdam The Netherlands
| | - Tari Haahtela
- Skin and Allergy Hospital, Helsinki University Hospital University of Helsinki Helsinki Finland
| | - Susanne Halken
- Hans Christian Andersen Children's Hospital Odense University Hospital Odense Denmark
| | - Peter W. Hellings
- Department of Otorhinolaryngology University Hospitals Leuven Leuven Belgium
- Academic Medical Center University of Amsterdam Amsterdam The Netherlands
| | - Despo Ierodiakonou
- Department of Social Medicine, Faculty of Medicine University of Crete and International Primary Care Respiratory Group Crete Greece
| | - Tomohisa Iinuma
- Department of Otorhinolaryngology Chiba University Hospital Chiba Japan
| | | | | | - Marek Jutel
- Department of Clinical Immunology Wrocław Medical University Wrocław Poland
| | - Igor Kaidashev
- Ukrainian Medical Stomatological Academy Poltava Ukraine
| | - Musa Khaitov
- Institute of Immunology, Federal Medicobiological Agency, Laboratory of Molecular immunology National Research Center Moscow Russian Federation
| | - Omer Kalayci
- Pediatric Allergy and Asthma Unit Hacettepe University School of Medicine Ankara Turkey
| | | | - Ludger Klimek
- Center for Rhinology and Allergology Wiesbaden Germany
| | - Marek L. Kowalski
- Department of Immunology and Allergy, Healthy Ageing Research Center Medical University of Lodz Lodz Poland
- Sach's Children and Youth Hospital, Södersjukhuset Stockholm Sweden
| | - Piotr Kuna
- Division of Internal Medicine, Asthma and Allergy, Barlicki University Hospital Medical University of Lodz Lodz Poland
| | - Violeta Kvedariene
- Department of Pathology, Faculty of Medicine, Institute of Biomedical Sciences Vilnius University Vilnius Lithuania
- Faculty of Medicine, Institute of Clinical medicine, Clinic of Chest diseases and Allergology Vilnius University Vilnius Lithuania
| | - Stefania La Grutta
- Institute of Biomedicine and Molecular Immunology (IBIM) National Research Council (CNR) Palermo Italy
| | - Désirée Larenas‐Linemann
- Center of Excellence in Asthma and Allergy Médica Sur Clinical Foundation and Hospital México City Mexico
| | - Susanne Lau
- Department of Pediatric Pneumology and Immunology Charité Universitätsmedizin Berlin Germany
| | | | - Lan Le
- University of Medicine and Pharmacy Hochiminh City Vietnam
| | - Karin Lodrup Carlsen
- Department of Paediatrics Oslo University Hospital Oslo Norway
- Faculty of Medicine, Institute of Clinical Medicine University of Oslo Oslo Norway
| | - Olga Lourenço
- Faculty of Health Sciences and CICS – UBI, Health Sciences Research Centre University of Beira Interior Covilhã Portugal
| | | | | | - Enrica Menditto
- CIRFF, Center of Pharmacoeconomics University of Naples Federico II Naples Italy
| | - Gregoire Mercier
- Département de l’Information Médicale, Unité Médico‐Economie University Hospital Montpellier France
| | - Joaquim Mullol
- Rhinology Unit & Smell Clinic, ENT Department Hospital Clínic Barcelona Spain
- Clinical & Experimental Respiratory Immunoallergy IDIBAPS, CIBERES, University of Barcelona Barcelona Spain
| | - Antonella Muraro
- Food Allergy Referral Centre Veneto Region, Department of Women and Child Health Padua General University Hospital Padua Italy
| | - Robyn O’Hehir
- Department of Allergy, Immunology and Respiratory Medicine, Alfred Hospital and Central Clinical School Monash University Melbourne Victoria Australia
| | - Yoshitaka Okamoto
- Department of Otorhinolaryngology Chiba University Hospital Chiba Japan
| | - Giovanni B. Pajno
- Department of Pediatrics, Allergy Unit University of Messina Messina Italy
| | - Hae‐Sim Park
- Department of Allergy and Clinical Immunology Ajou University School of Medicine Suwon South Korea
| | - Petr Panzner
- Department of Immunology and Allergology, Faculty of Medicine in Pilsen Charles University in Prague Pilsen Czech Republic
| | - Giovanni Passalacqua
- Allergy and Respiratory Diseases Ospedale Policlino San Martino ‐University of Genoa Genoa Italy
| | | | - Graham Roberts
- David Hide Centre, St Mary's Hospital Isle of Wight and University of Southampton Southampton UK
| | - Ruby Pawankar
- Department of Pediatrics Nippon Medical School Tokyo Japan
| | | | | | - Dermot Ryan
- Allergy and Respiratory Research Group, Medical School, Usher Institute of Population Health Sciences and Informatics University of Edinburgh Edinburgh UK
| | - Bolesław Samolinski
- Department of Prevention of Environmental Hazards and Allergology Medical University of Warsaw Warsaw Poland
| | - Mario Sanchez‐Borges
- Allergy and Clinical Immunology Department Centro Medico‐Docente La Trinidad Caracas Venezuela
| | - Glenis Scadding
- The Royal National TNE Hospital University College London London UK
| | - Mohamed H. Shamji
- Immunomodulation and Tolerance Group Imperial College London London UK
- Allergy and Clinical Immunology Imperial College London London UK
| | - Aziz Sheikh
- The Usher Institute of Population Health Sciences and Informatics The University of Edinburgh Edinburgh UK
| | - Gunter J. Sturm
- Department of Dermatology and Venerology Medical University of Graz Graz Austria
- Outpatient Allergy Clinic Reumannplatz Vienna Austria
| | - Ana Todo Bom
- Imunoalergologia, Centro Hospitalar Universitário de Coimbra and Faculty of Medicine University of Coimbra Coimbra Portugal
| | - Sanna Toppila‐Salmi
- Skin and Allergy Hospital, Helsinki University Hospital University of Helsinki Helsinki Finland
| | | | - Arunas Valiulis
- Clinic of Children's Diseases Vilnius University Institute of Clinical Medicine Vilnius Lithuania
- Department of Public Health Institute of Health Sciences Vilnius Lithuania
- European Academy of Paediatrics (EAP/UEMS‐SP) Brussels Belgium
| | - Erkka Valovirta
- Department of Lung Diseases and Clinical Immunology, Terveystalo Allergy Clinic University of Turku Turku Finland
| | - Maria‐Teresa Ventura
- Unit of Geriatric Immunoallergology University of Bari Medical School Bari Italy
| | - Ulrich Wahn
- Pediatric Department Charité, Berlin Germany
| | | | - Dana Wallace
- Nova Southeastern University Fort Lauderdale Florida
| | - Susan Waserman
- Department of Medicine, Clinical Immunology and Allergy McMaster University Hamilton Ontario
| | - Arzu Yorgancioglu
- Department of Pulmonary Diseases, Faculty of Medicine Celal Bayar University Manisa Turkey
| | - Torsten Zuberbier
- Department of Dermatology and Allergy Charité ‐ Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Berlin Institute of Health, Comprehensive Allergy Centre, Member of GALEN, Humboldt‐Uniersität zu Berlin Berlin Germany
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ARIA-Leitlinie 2019: Behandlung der allergischen Rhinitis im deutschen Gesundheitssystem. ALLERGO JOURNAL 2019. [DOI: 10.1007/s15007-019-1938-2] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 10/25/2022]
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46
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Bousquet J, Schünemann HJ, Togias A, Bachert C, Erhola M, Hellings PW, Klimek L, Pfaar O, Wallace D, Ansotegui I, Agache I, Bedbrook A, Bergmann KC, Bewick M, Bonniaud P, Bosnic-Anticevich S, Bossé I, Bouchard J, Boulet LP, Brozek J, Brusselle G, Calderon MA, Canonica WG, Caraballo L, Cardona V, Casale T, Cecchi L, Chu DK, Costa EM, Cruz AA, Czarlewski W, D'Amato G, Devillier P, Dykewicz M, Ebisawa M, Fauquert JL, Fokkens WJ, Fonseca JA, Fontaine JF, Gemicioglu B, van Wijk RG, Haahtela T, Halken S, Ierodiakonou D, Iinuma T, Ivancevich JC, Jutel M, Kaidashev I, Khaitov M, Kalayci O, Kleine Tebbe J, Kowalski ML, Kuna P, Kvedariene V, La Grutta S, Larenas-Linnemann D, Lau S, Laune D, Le L, Lieberman P, Lodrup Carlsen KC, Lourenço O, Marien G, Carreiro-Martins P, Melén E, Menditto E, Neffen H, Mercier G, Mosgues R, Mullol J, Muraro A, Namazova L, Novellino E, O'Hehir R, Okamoto Y, Ohta K, Park HS, Panzner P, Passalacqua G, Pham-Thi N, Price D, Roberts G, Roche N, Rolland C, Rosario N, Ryan D, Samolinski B, Sanchez-Borges M, Scadding GK, Shamji MH, Sheikh A, Bom AMT, Toppila-Salmi S, Tsiligianni I, Valentin-Rostan M, Valiulis A, Valovirta E, Ventura MT, Walker S, Waserman S, Yorgancioglu A, Zuberbier T. Next-generation Allergic Rhinitis and Its Impact on Asthma (ARIA) guidelines for allergic rhinitis based on Grading of Recommendations Assessment, Development and Evaluation (GRADE) and real-world evidence. J Allergy Clin Immunol 2019; 145:70-80.e3. [PMID: 31627910 DOI: 10.1016/j.jaci.2019.06.049] [Citation(s) in RCA: 272] [Impact Index Per Article: 45.3] [Reference Citation Analysis] [Abstract] [Key Words] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/01/2019] [Revised: 05/07/2019] [Accepted: 06/12/2019] [Indexed: 01/16/2023]
Abstract
The selection of pharmacotherapy for patients with allergic rhinitis aims to control the disease and depends on many factors. Grading of Recommendations Assessment, Development and Evaluation (GRADE) guidelines have considerably improved the treatment of allergic rhinitis. However, there is an increasing trend toward use of real-world evidence to inform clinical practice, especially because randomized controlled trials are often limited with regard to the applicability of results. The Contre les Maladies Chroniques pour un Vieillissement Actif (MACVIA) algorithm has proposed an allergic rhinitis treatment by a consensus group. This simple algorithm can be used to step up or step down allergic rhinitis treatment. Next-generation guidelines for the pharmacologic treatment of allergic rhinitis were developed by using existing GRADE-based guidelines for the disease, real-world evidence provided by mobile technology, and additive studies (allergen chamber studies) to refine the MACVIA algorithm.
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Affiliation(s)
- Jean Bousquet
- MACVIA-France, Fondation Partenariale FMC VIA-LR, Montpellier, France; VIMA, INSERM U 1168, VIMA: Ageing and chronic diseases Epidemiological and public health approaches, Villejuif, France, Université Versailles St-Quentin-en-Yvelines, UMR-S 1168, Montigny le Bretonneux, Euforea, Brussels, Belgium and Charité, Universitätsmedizin Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Comprehensive Allergy Center, Department of Dermatology and Allergy, Berlin, Germany.
| | - Holger J Schünemann
- Department of Health Research Methods, Evidence, and Impact, Division of Immunology and Allergy, McMaster University, Hamilton, Ontario, Canada
| | - Akdis Togias
- Division of Allergy, Immunology, and Transplantation (DAIT), National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Md
| | - Claus Bachert
- Upper Airways Research Laboratory, ENT Department, Ghent University Hospital, Ghent, Belgium
| | - Martina Erhola
- National Institute for Health and Welfare, Helsinki, Finland
| | - Peter W Hellings
- Department of Otorhinolaryngology, University Hospitals Leuven, and Academic Medical Center, University of Amsterdam, The Netherlands, and Euforea, Brussels, Belgium
| | - Ludger Klimek
- Center for Rhinology and Allergology, Wiesbaden, Germany
| | - Oliver Pfaar
- Department of Otorhinolaryngology, Head and Neck Surgery, Section of Rhinology and Allergy, University Hospital Marburg, Philipps-Universität Marburg, Marburg, Germany
| | - Dana Wallace
- Nova Southeastern University, Fort Lauderdale, Fla
| | - Ignacio Ansotegui
- Department of Allergy and Immunology, Hospital Quirónsalud Bizkaia, Erandio, Spain
| | - Ioana Agache
- Faculty of Medicine, Transylvania University, Brasov, Romania
| | - Anna Bedbrook
- MACVIA-France, Fondation Partenariale FMC VIA-LR, Montpellier, France
| | - Karl-Christian Bergmann
- Charité-Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Uniersität zu Berlin and Berlin Institute of Health, Comprehensive Allergy-Centre, Department of Dermatology and Allergy, member of GA(2)LEN, Berlin, Germany
| | | | | | - Sinthia Bosnic-Anticevich
- Woolcock Institute of Medical Research, University of Sydney and Woolcock Emphysema Centre and Sydney Local Health District, Glebe, Australia
| | | | | | | | - Jan Brozek
- Department of Health Research Methods, Evidence, and Impact, Division of Immunology and Allergy, McMaster University, Hamilton, Ontario, Canada
| | - Guy Brusselle
- Department of Respiratory Medicine, Ghent University Hospital, Ghent, Belgium
| | - Moises A Calderon
- Imperial College London-National Heart and Lung Institute, Royal Brompton Hospital NHS, London, United Kingdom
| | - Walter G Canonica
- Personalized Medicine Clinic Asthma & Allergy, Humanitas University, Humanitas Research Hospital, Rozzano, Milan, Italy
| | - Luis Caraballo
- Institute for Immunological Research, University of Cartagena, Campus de Zaragocilla, Edificio Biblioteca Primer Piso, and the Foundation for the Development of Medical and Biological Sciences (Fundemeb), Cartagena, Colombia
| | - Vicky Cardona
- Allergy Section, Department of Internal Medicine, Hospital Vall d'Hebron & ARADyAL research network, Barcelona, Spain
| | - Thomas Casale
- the Division of Allergy/Immunology, University of South Florida, Tampa, Fla
| | - Lorenzo Cecchi
- SOS Allergology and Clinical Immunology, USL Toscana Centro, Prato, Italy
| | - Derek K Chu
- Department of Health Research Methods, Evidence, and Impact, Division of Immunology and Allergy, McMaster University, Hamilton, Ontario, Canada
| | - Elisio M Costa
- UCIBIO, REQUIMTE, Faculty of Pharmacy, and Competence Center on Active and Healthy Ageing of University of Porto (AgeUPNetWork), University of Porto, Porto, Portugal
| | - Alvaro A Cruz
- ProAR-Nucleo de Excelencia em Asma, Federal University of Bahia, and the WHO GARD Planning Group, Bahia, Brazil
| | | | - Gennaro D'Amato
- Division of Respiratory and Allergic Diseases, Hospital "A Cardarelli", University of Naples Federico II, Naples, Italy
| | - Philippe Devillier
- UPRES EA220, Pôle des Maladies des Voies Respiratoires, Hôpital Foch, Université Paris-Saclay, Suresnes, France; Allergy and Clinical Immunology Section, National Heart and Lung Institute, Imperial College London, London, United Kingdom
| | - Mark Dykewicz
- Section of Allergy and Immunology, Saint Louis University School of Medicine, St Louis, Mo
| | - Motohiro Ebisawa
- Clinical Research Center for Allergy and Rheumatology, Sagamihara National Hospital, Sagamihara, Japan
| | - Jean-Louis Fauquert
- Unité de pneumo-allergologie de l'enfant, pôle pédiatrique Pr-Labbé, CHU de Clermont-Ferrand-Estaing, Clermont-Ferrand, France
| | - Wytske J Fokkens
- Department of Otorhinolaryngology, Amsterdam University Medical Centres, AMC, Amsterdam, The Netherlands
| | - Joao A Fonseca
- CINTESIS, Center for Research in Health Technology and Information Systems, Faculdade de Medicina da Universidade do Porto, and Medida, Porto, Portugal
| | | | - Bilun Gemicioglu
- Department of Pulmonary Diseases, Istanbul University-Cerrahpasa, Cerrahpasa Faculty of Medicine, Istanbul, Turkey
| | - Roy Gerth van Wijk
- Department of Internal Medicine, section of Allergology, Erasmus MC, Rotterdam, The Netherlands
| | - Tari Haahtela
- Skin and Allergy Hospital, Helsinki University Hospital, and University of Helsinki, Helsinki, Finland
| | - Susanne Halken
- Hans Christian Andersen Children's Hospital, Odense University Hospital, Odense, Denmark
| | - Despo Ierodiakonou
- Department of Social Medicine, Faculty of Medicine, University of Crete and International Primary Care Respiratory Group, Crete, Greece
| | - Tomohisa Iinuma
- Department of Otorhinolaryngology, Chiba University Hospital, Chiba, Japan
| | | | - Marek Jutel
- Department of Clinical Immunology, Wrocław Medical University, Wroclaw, Poland
| | - Igor Kaidashev
- Ukrainina Medical Stomatological Academy, Poltava, Ukraine
| | - Musa Khaitov
- National Research Center, Institute of Immunology, Federal Medicobiological Agency, Laboratory of Molecular immunology, Moscow, Russia
| | - Omer Kalayci
- Pediatric Allergy and Asthma Unit, Hacettepe University School of Medicine, Ankara, Turkey
| | - Jorg Kleine Tebbe
- Allergy & Asthma Center Westend, Outpatient & Clinical Research Center, Berlin, Germany
| | - Marek L Kowalski
- Department of Immunology and Allergy, Healthy Ageing Research Center, Medical University of Lodz, Lodz, Poland
| | - Piotr Kuna
- Division of Internal Medicine, Asthma and Allergy, Barlicki University Hospital, Medical University of Lodz, Lodz, Poland
| | - Violeta Kvedariene
- Institute of Biomedical Sciences, Department of Pathology, Faculty of Medicine, Vilnius University and Institute of Clinical medicine, Clinic of Chest diseases and Allergology, Faculty of Medicine, Vilnius University, Vilnius, Lithuania
| | - Stefania La Grutta
- Institute of Biomedicine and Molecular Immunology (IBIM), National Research Council (CNR), Palermo, Italy
| | - Désirée Larenas-Linnemann
- Center of Excellence in Asthma and Allergy, Médica Sur Clinical Foundation and Hospital, Mexico City, Mexico
| | - Susanne Lau
- Department of Paediatric Pneumology, Immunology and Intensive Care, Charité Universitätsmedizin, Berlin, Germany
| | | | - Lan Le
- University of Medicine and Pharmacy, Ho Chi Minh City, Vietnam
| | - Philipp Lieberman
- Departments of Internal Medicine and Pediatrics (Divisions of Allergy and Immunology), University of Tennessee College of Medicine, Germantown, Tenn
| | - Karin C Lodrup Carlsen
- Oslo University Hospital, Department of Paediatrics, Oslo, and University of Oslo, Faculty of Medicine, Institute of Clinical Medicine, Oslo, Norway
| | - Olga Lourenço
- Faculty of Health Sciences and CICS-UBI, Health Sciences Research Centre, University of Beira Interior, Covilhã, Portugal
| | | | - Pedro Carreiro-Martins
- Hospital de Dona Estefânia, Centro Hospitalar de Lisboa Central, EPE, Lisbon, and Nova Medical School, CEDOC, Integrated Pathophysiological Mechanisms Research Group, Lisbon, Portugal
| | - Erik Melén
- Sachs' Children and Youth Hospital, Södersjukhuset, Stockholm and Institute of Environmental Medicine, Karolinska Institutet, Stockholm, Sweden
| | - Enrica Menditto
- CIRFF, Center of Pharmacoeconomics, University of Naples Federico II, Naples, Italy
| | - Hugo Neffen
- Center of Allergy, Immunology and Respiratory Diseases, Santa Fe, and the Center for Allergy and Immunology, Santa Fe, Argentina
| | - Gregoire Mercier
- Unité Médico-Economie, Département de l'Information Médicale, University Hospital, Montpellier, France
| | - Ralph Mosgues
- Institute of Medical Statistics, and Computational Biology, Medical Faculty, University of Cologne, and Clinical Research International, Hamburg, Germany
| | - Joaquim Mullol
- Rhinology Unit & Smell Clinic, ENT Department, Hospital Clínic, and Clinical & Experimental Respiratory Immunoallergy, IDIBAPS, CIBERES, University of Barcelona, Barcelona, Spain
| | - Antonella Muraro
- Food Allergy Referral Centre Veneto Region, Department of Women and Child Health, Padua General University Hospital, Padua, Italy
| | - Leyla Namazova
- Scientific Centre of Children's Health under the MoH, Moscow, and Russian National Research Medical University named Pirogov, Moscow, Russia
| | - Ettore Novellino
- Department of Pharmacy of University of Naples Federico II, Naples, Italy
| | - Robyn O'Hehir
- Department of Allergy, Immunology and Respiratory Medicine, Alfred Hospital and Central Clinical School, Monash University, Melbourne, and the Department of Immunology, Monash University, Melbourne, Australia
| | - Yoshitaka Okamoto
- Department of Otorhinolaryngology, Chiba University Hospital, Chiba, Japan
| | - Ken Ohta
- National Hospital Organization, Tokyo National Hospital, Tokyo, Japan
| | - Hae Sim Park
- Department of Allergy and Clinical Immunology, Ajou University School of Medicine, Suwon, South Korea
| | - Petr Panzner
- Department of Immunology and Allergology, Faculty of Medicine in Pilsen, Charles University in Prague, Pilsen, Czech Republic
| | - Giovanni Passalacqua
- Allergy and Respiratory Diseases, Ospedale Policlino San Martino-University of Genoa, Genoa, Italy
| | - Nhan Pham-Thi
- Allergy Department, Pasteur Institute, Paris, France
| | - David Price
- Observational and Pragmatic Research Institute, Singapore
| | - Graham Roberts
- David Hide Centre, St Mary's Hospital, Isle of Wight, and University of Southampton, Southampton, United Kingdom
| | - Nicolas Roche
- Pneumologie et Soins Intensifs Respiratoires, Hôpitaux Universitaires Paris, and Hôpital Cochin, Paris, France
| | | | - Nelson Rosario
- Hospital de Clinicas, University of Parana, Parana, Brazil
| | - Dermot Ryan
- Allergy and Respiratory Research Group, University of Edinburgh, Edinburgh, United Kingdom
| | - Boleslaw Samolinski
- Department of Prevention of Envinronmental Hazards and Allergology, Medical University of Warsaw, Warsaw, Poland
| | - Mario Sanchez-Borges
- Allergy and Clinical Immunology Department, Centro Medico-Docente La Trinidad, Caracas, Venezuela
| | - Glenis K Scadding
- Royal National TNE Hospital, University College London, London, United Kingdom
| | - Mohamed H Shamji
- Immunomodulation and Tolerance Group and Allergy and Clinical Immunology, Imperial College London, London, United Kingdom
| | - Aziz Sheikh
- Usher Institute of Population Health Sciences and Informatics, University of Edinburgh, Edinburgh, United Kingdom
| | - Ana-Maria Todo Bom
- Imunoalergologia, Centro Hospitalar Universitário de Coimbra and Faculty of Medicine, University of Coimbra, Coimbra, Portugal
| | - Sanna Toppila-Salmi
- Skin and Allergy Hospital, Helsinki University Hospital and University of Helsinki, Helsinki, Finland
| | - Ioana Tsiligianni
- Department of Social Medicine, Faculty of Medicine, University of Crete and International Primary Care Respiratory Group, Crete, Greece
| | | | - Arunas Valiulis
- Vilnius University Institute of Clinical Medicine, Clinic of Children's Diseases, and Institute of Health Sciences, Department of Public Health, Vilnius, Mexico, and the European Academy of Paediatrics (EAP/UEMS-SP), Brussels, Belgium
| | - Erkka Valovirta
- Department of Lung Diseases and Clinical Immunology, University of Turku and Terveystalo Allergy Clinic, Turku, Finland
| | - Maria-Teresa Ventura
- University of Bari Medical School, Unit of Geriatric Immunoallergology, Bari, Italy
| | | | - Susan Waserman
- Department of Medicine, Clinical Immunology and Allergy, McMaster University, Hamilton, Ontario, Canada
| | - Arzu Yorgancioglu
- Department of Pulmonary Diseases, Celal Bayar University, Faculty of Medicine, Manisa, Turkey
| | - Torsten Zuberbier
- Charité-Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Uniersität zu Berlin and Berlin Institute of Health, Comprehensive Allergy-Centre, Department of Dermatology and Allergy, member of GA(2)LEN, Berlin, Germany
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Leonardi A, Silva D, Perez Formigo D, Bozkurt B, Sharma V, Allegri P, Rondon C, Calder V, Ryan D, Kowalski ML, Delgado L, Doan S, Fauquert JL. Management of ocular allergy. Allergy 2019; 74:1611-1630. [PMID: 30887530 DOI: 10.1111/all.13786] [Citation(s) in RCA: 59] [Impact Index Per Article: 9.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/27/2019] [Revised: 02/15/2019] [Accepted: 02/20/2019] [Indexed: 12/13/2022]
Abstract
The treatment and management of ocular allergy (OA) remain a major concern for different specialties, including allergists, ophthalmologists, primary care physicians, rhinologists, pediatricians, dermatologists, clinical immunologists, and pharmacists. We performed a systematic review of all relevant publications in MEDLINE, Scopus, and Web Science including systematic reviews and meta-analysis. Publications were considered relevant if they addressed treatments, or management strategies of OA. A further wider systematic literature search was performed if no evidence or good quality evidence was found. There are effective drugs for the treatment of OA; however, there is a lack an optimal treatment for the perennial and severe forms. Topical antihistamines, mast cell stabilizers, or double-action drugs are the first choice of treatment. All of them are effective in reducing signs and symptoms of OA. The safety and optimal dosing regimen of the most effective topical anti-inflammatory drugs, corticosteroids, are still a major concern. Topical calcineurin inhibitors may be used in steroid-dependent/resistant cases of severe allergic keratoconjunctivitis. Allergen-specific immunotherapy may be considered in cases of failure of first-line treatments or to modify the natural course of OA disease. Based on the current wealth of publications and on the collective experience, recommendations on management of OA have been proposed.
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Affiliation(s)
- Andrea Leonardi
- Ophthalmology Unit, Department of Neuroscience University of Padua Padua Italy
| | - Diana Silva
- Basic and Clinical Immunology, Department of Pathology, Faculty of Medicine, Serviço de Imunoalergologia, Centro Hospitalar São João University of Porto, EPE – Porto Porto Portugal
| | - Daniel Perez Formigo
- Department of Ophthalmology Hospital Universitario de Torrejon Madrid Spain
- Faculty of Medicine University of Francisco de Vitoria (UFV) Pozuelo de Alarcon, Madrid Spain
| | - Banu Bozkurt
- Department of Ophthalmology, Faculty of Medicine Selcuk University Konya Turkey
| | - Vibha Sharma
- Department of Paediatric Allergy and Immunology, Royal Manchester Children's Hospital Manchester University NHS Foundation Trust Manchester UK
| | - Pia Allegri
- Allergic Conjunctivitis Unit, Ocular Inflammatory Diseases Referral Center, Rapallo Hospital Ophthalmology DepartmentGenova Italy
| | - Carmen Rondon
- Allergy Unit, Regional University Hospital of Malaga, IBIMA UMA Malaga Spain
| | - Virginia Calder
- Department of Ocular Biology & Therapeutics UCL Institute of Ophthalmology London UK
| | - Dermot Ryan
- Allergy and Respiratory Research Group, Medical School, Usher Institute of Population Health Sciences and Informatics University of Edinburgh Edinburgh UK
| | - Marek L. Kowalski
- Department of Immunology, Rheumatology, and Allergy Medical University of Lodz Lodz Poland
| | - Luis Delgado
- Basic and Clinical Immunology, Department of Pathology, Faculty of Medicine, Serviço de Imunoalergologia, Centro Hospitalar São João University of Porto, EPE – Porto Porto Portugal
| | - Serge Doan
- Service d’Ophtalmologie Hôpital Bichat and Fondation A. de Rothschild Paris France
| | - Jean L. Fauquert
- CHU Estaing Unité d’Allergologie de l’Enfant Clermont‐Ferrand Cedex1 France
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48
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Scadding GK, Kariyawasam HH, Scadding G, Mirakian R, Buckley RJ, Dixon T, Durham SR, Farooque S, Jones N, Leech S, Nasser SM, Powell R, Roberts G, Rotiroti G, Simpson A, Smith H, Clark AT. BSACI guideline for the diagnosis and management of allergic and non-allergic rhinitis (Revised Edition 2017; First edition 2007). Clin Exp Allergy 2019; 47:856-889. [PMID: 30239057 DOI: 10.1111/cea.12953] [Citation(s) in RCA: 155] [Impact Index Per Article: 25.8] [Reference Citation Analysis] [Abstract] [Key Words] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/06/2017] [Revised: 05/01/2017] [Accepted: 05/04/2017] [Indexed: 12/12/2022]
Abstract
This is an updated guideline for the diagnosis and management of allergic and non-allergic rhinitis, first published in 2007. It was produced by the Standards of Care Committee of the British Society of Allergy and Clinical Immunology, using accredited methods. Allergic rhinitis is common and affects 10-15% of children and 26% of adults in the UK, it affects quality of life, school and work attendance, and is a risk factor for development of asthma. Allergic rhinitis is diagnosed by history and examination, supported by specific allergy tests. Topical nasal corticosteroids are the treatment of choice for moderate to severe disease. Combination therapy with intranasal corticosteroid plus intranasal antihistamine is more effective than either alone and provides second line treatment for those with rhinitis poorly controlled on monotherapy. Immunotherapy is highly effective when the specific allergen is the responsible driver for the symptoms. Treatment of rhinitis is associated with benefits for asthma. Non-allergic rhinitis also is a risk factor for the development of asthma and may be eosinophilic and steroid-responsive or neurogenic and non- inflammatory. Non-allergic rhinitis may be a presenting complaint for systemic disorders such as granulomatous or eosinophilic polyangiitis, and sarcoidoisis. Infective rhinitis can be caused by viruses, and less commonly by bacteria, fungi and protozoa.
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Affiliation(s)
- G K Scadding
- The Royal National Throat Nose and Ear Hospital, London, UK
| | - H H Kariyawasam
- The Royal National Throat Nose and Ear Hospital, London, UK.,UCLH NHS Foundation Trust, London, UK
| | - G Scadding
- Department of Upper Respiratory Medicine, Imperial College NHLI, London, UK
| | - R Mirakian
- The Royal National Throat Nose and Ear Hospital, London, UK
| | - R J Buckley
- Vision and Eye Research Unit, Anglia Ruskin University, Cambridge, UK
| | - T Dixon
- Royal Liverpool and Broad green University Hospital NHS Trust, Liverpool, UK
| | - S R Durham
- Department of Upper Respiratory Medicine, Imperial College NHLI, London, UK
| | - S Farooque
- Chest and Allergy Department, St Mary's Hospital, Imperial College NHS Trust, London, UK
| | - N Jones
- The Park Hospital, Nottingham, UK
| | - S Leech
- Department of Child Health, King's College Hospital, London, UK
| | - S M Nasser
- Cambridge University Hospital NHS Foundation Trust, Cambridge, UK
| | - R Powell
- Department of Clinical Immunology and Allergy, Nottingham University, Nottingham UK
| | - G Roberts
- Department of Child Health, University of Southampton Hospital, Southampton, UK
| | - G Rotiroti
- The Royal National Throat Nose and Ear Hospital, London, UK
| | - A Simpson
- Division of Infection, Immunity and Respiratory Medicine, University of Manchester, UK
| | - H Smith
- Division of Primary Care and Public Health, University of Sussex, Brighton, UK
| | - A T Clark
- Cambridge University Hospital NHS Foundation Trust, Cambridge, UK
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49
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Bjermer L, Westman M, Holmström M, Wickman MC. The complex pathophysiology of allergic rhinitis: scientific rationale for the development of an alternative treatment option. Allergy Asthma Clin Immunol 2019; 15:24. [PMID: 31015846 PMCID: PMC6469109 DOI: 10.1186/s13223-018-0314-1] [Citation(s) in RCA: 47] [Impact Index Per Article: 7.8] [Reference Citation Analysis] [Abstract] [Key Words] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/01/2018] [Accepted: 12/20/2018] [Indexed: 01/27/2023] Open
Abstract
Allergic rhinitis (AR) poses a global health problem and can be challenging to treat. Many of the current symptomatic treatments for AR have been available for decades, yet there has been little improvement in patient quality of life or symptom burden over the years. In this review, we ask why this might be and explore the pathophysiological gaps that exist within the various AR treatment classes. We focus on the benefits and drawbacks of different treatment options and delivery routes for AR treatments and consider how, given what is known about AR pathophysiology and symptomatology, patients may be offered more effective treatment options for rapid, effective, and sustained AR control. In particular, we consider how a new AR preparation, MP-AzeFlu (Dymista®, Meda, Sweden), comprising a formulation of an intranasal antihistamine (azelastine hydrochloride), an intranasal corticosteroid (fluticasone propionate), and excipients delivered in a single spray, may offer benefits over and above single and multiple AR therapy options. We review the evidence in support of this treatment across the spectrum of AR disease. The concept of AR control is also reviewed within the context of new European Union and Contre les Maladies Chroniques pour un VIeillissement Actif-Allergic Rhinitis and its Impact on Asthma initiatives.
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Affiliation(s)
- Leif Bjermer
- 1Department of Respiratory Medicine & Allergology, Skane University Hospital, 22185, Lund, Sweden
| | - Marit Westman
- 2Dept. of ENT-diseases, Karolinska University Hospital, 171 76 Stockholm, Sweden.,3Immunology and Allergy Unit, Department of Medicine Solna, Karolinska Institutet, 171 77 Stockholm, Sweden
| | - Mats Holmström
- 4Dept. of Clinical Science, Intervention and Technology, Division of Ear, Nose and Throat Diseases, Karolinska Institutet, 171 77 Stockholm, Sweden
| | - Magnus C Wickman
- 5Department of Environmental Medicine, Karolinska Institutet, 171 77 Stockholm, Sweden.,Sach's Children's Hospital, 118 83 Stockholm, Sweden
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50
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Debbaneh PM, Bareiss AK, Wise SK, McCoul ED. Intranasal Azelastine and Fluticasone as Combination Therapy for Allergic Rhinitis: Systematic Review and Meta-analysis. Otolaryngol Head Neck Surg 2019; 161:412-418. [DOI: 10.1177/0194599819841883] [Citation(s) in RCA: 6] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/25/2022]
Abstract
Objective Combination therapy with intranasal azelastine and fluticasone propionate is an option for treatment of allergic rhinitis. This systematic review and meta-analysis examines existing literature to determine efficacy in treating allergic rhinitis compared to monotherapy. Data Sources The PubMed, EMBASE, Cochrane, and MEDLINE databases were systematically searched for randomized controlled trials using AzeFlu nasal spray. Review Methods Randomized, controlled trials that reported symptom relief of allergic rhinitis in males and females of all ages were included. Results were reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) standard. Results Systematic review identified 8 articles suitable for review. The risk of bias was generally low. All studies exhibited a greater decrease in patient-reported symptom scores in patients treated with combination therapy compared to monotherapy or placebo. Meta-analysis revealed superiority of combination therapy in reducing Total Nasal Symptom Score compared to placebo (mean change from baseline: −2.41; 95% confidence interval [CI], −2.82 to −1.99; P < .001; I 2 = 60%), azelastine (mean change from baseline: −1.40; 95% CI, −1.82 to −0.98; P < .001; I 2 = 0%), and fluticasone (mean change from baseline: −0.74; 95% CI, −1.17 to −0.31; P < .001; I 2 = 12%). Conclusion Current evidence supports both efficacy and superiority of combination intranasal azelastine and fluticasone in reducing patient-reported symptom scores in patients with allergic rhinitis. Combination nasal spray should be considered as second-line therapy in patients with allergic rhinitis that is not controlled with monotherapy.
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Affiliation(s)
- Peter M. Debbaneh
- Department of Otolaryngology–Head and Neck Surgery, Tulane University School of Medicine, New Orleans, Louisiana, USA
| | - Anna K. Bareiss
- Department of Otolaryngology–Head and Neck Surgery, Tulane University School of Medicine, New Orleans, Louisiana, USA
| | - Sarah K. Wise
- Department of Otolaryngology—Head and Neck Surgery, Emory University, Atlanta, Georgia, USA
| | - Edward D. McCoul
- Department of Otolaryngology–Head and Neck Surgery, Tulane University School of Medicine, New Orleans, Louisiana, USA
- Ochsner Clinical School, University of Queensland School of Medicine, New Orleans, Louisiana, USA
- Ochsner Clinic Foundation, Department of Otorhinolaryngology, New Orleans, Louisiana, USA
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