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Paoletti G, Nappi E, Bragato MC, Valli P, Giovannini M, Gargano D, Pecoraro L, Diso D, Barbaglia S, Canonica GW, Heffler E. Allergen immunotherapy in Italy: How, when, and why-A real-world study conducted through a patient association. World Allergy Organ J 2025; 18:101015. [PMID: 39810828 PMCID: PMC11732536 DOI: 10.1016/j.waojou.2024.101015] [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: 08/06/2024] [Revised: 10/08/2024] [Accepted: 11/17/2024] [Indexed: 01/16/2025] Open
Abstract
Background Allergen immunotherapy (AIT) is the only treatment that modifies the natural course of allergies. However, AIT is only used in some eligible patients, is frequently underused, and only a few studies investigated this aspects. Understanding AIT utilization patterns might disclose information about why it is underused, thus providing valuable insights on how to broaden the positive impact it can have on the population. Methods A questionnaire aiming to assess the trends of the use of AIT in Italy, patient health literacy on AIT, and the impact of respiratory allergies and AIT on patients' lives was submitted to patients affiliated with Respiriamo Insieme APS patient's association during the period between May and October 2023. Results Nine hundred forty-four patients completed the questionnaire. Most patients reported to be affected by allergic rhinitis (81.1%), allergic asthma (45.4%), and/or allergic conjunctivitis (41.2%), and many of them presenting a combination of these diseases. Only 53.8% knew about AIT's existence, and AIT was proposed to only 33.1% of the 858 patients affected by allergic rhinitis and/or allergic asthma, of which 29.2% decided not to initiate the therapy. Common reasons for AIT refusal were related to indecisiveness (26.5%), costs (22.9%), and skepticism (19.3%). Among the remaining 70.8% who accepted to start AIT, 21.4% discontinued the treatment beforehand, on average 18.26 months from initiation. There was a high heterogeneity in the suggested duration of AIT, with 20.4% of patients receiving indications to continue AIT for less than 3 years. AIT positively impacted patients' lives as most patients who completed AIT found it effective and safe, and experienced a significant reduction in the workdays/schooldays lost due to disease exacerbations. Conclusions The outcomes of this research pointed out a lot of misinformation surrounding AIT, calling for improvements in awareness and information on its efficacy and safety. Also, we noted a significant reduction in work/school days lost in patients who completed AIT and a good patient-reported safety and efficacy profile. We advocate for better economic accessibility through national-level standardization in treatment refundability. Notably, the collaboration with the patient association was crucial, and it would have been challenging to conduct this research otherwise.
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Affiliation(s)
- Giovanni Paoletti
- Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, MI, Italy
- Personalized Medicine, Asthma and Allergy, IRCCS Humanitas Research Hospital, Rozzano, MI, Italy
| | - Emanuele Nappi
- Personalized Medicine, Asthma and Allergy, IRCCS Humanitas Research Hospital, Rozzano, MI, Italy
| | - Maria Chiara Bragato
- Personalized Medicine, Asthma and Allergy, IRCCS Humanitas Research Hospital, Rozzano, MI, Italy
| | - Paola Valli
- Personalized Medicine, Asthma and Allergy, IRCCS Humanitas Research Hospital, Rozzano, MI, Italy
| | - Mattia Giovannini
- Allergy Unit, Meyer Children's Hospital IRCCS, Florence, Italy
- Department of Health Sciences, University of Florence, Florence, Italy
| | - Domenico Gargano
- Allergy Unit, Azienda Ospedaliera S. Giuseppe Moscati, Avellino, Italy
| | - Luca Pecoraro
- Pediatric Unit, Department of Surgical Sciences, Dentistry, Gynecology and Pediatrics, University of Verona, Verona, Italy
| | - Deborah Diso
- Associazione Nazionale Pazienti Respiriamo Insieme-APS, Padua, Italy
| | - Simona Barbaglia
- Associazione Nazionale Pazienti Respiriamo Insieme-APS, Padua, Italy
| | - Giorgio Walter Canonica
- Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, MI, Italy
- Personalized Medicine, Asthma and Allergy, IRCCS Humanitas Research Hospital, Rozzano, MI, Italy
| | - Enrico Heffler
- Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, MI, Italy
- Personalized Medicine, Asthma and Allergy, IRCCS Humanitas Research Hospital, Rozzano, MI, Italy
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Wandalsen GF, Aarestrup FM, Solé D. Is allergen immunotherapy a model of personalized treatment in pediatric respiratory allergy? Curr Opin Allergy Clin Immunol 2024; 24:88-93. [PMID: 38359080 DOI: 10.1097/aci.0000000000000968] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 02/17/2024]
Abstract
PURPOSE OF REVIEW To review recent evidence on allergen immunotherapy (AIT) as a model of personalized medicine in the treatment of children and adolescents with respiratory allergies. RECENT FINDINGS Meta-analysis and systematic review studies continue to point out that AIT is an effective treatment for children with respiratory allergies. Molecular allergy allows the understanding of patient sensitization profiles that frequently change the prescription of AIT. There is still a lack of evidence showing that this personalized prescription of AIT is associated with better clinical outcomes. The nasal allergen challenge has extended the indications of AIT for a new group of subjects with local allergic rhinitis. Patient selection of allergens involved in the increasingly personalized composition of extracts to be used in AIT increasingly characterizes it as personalized medicine. SUMMARY Despite the numerous studies carried out to identify the best biomarker to evaluate the response to AIT, there is still much disagreement, and clinical assessment (symptoms, quality of life, among others) continues to be the best way to evaluate the therapeutic success of AIT.
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Affiliation(s)
- Gustavo Falbo Wandalsen
- Division of Allergy, Clinical Immunology and Rheumatology, Department of Pediatrics, Federal University of São Paulo, Escola Paulista de Medicina, São Paulo
| | - Fernando Monteiro Aarestrup
- Faculty of Medicine, Federal University of Juiz de Fora, Post-Graduate Program in Health School of Medicine. Minas Gerais
| | - Dirceu Solé
- Division of Allergy, Clinical Immunology and Rheumatology, Department of Pediatrics, Federal University of São Paulo, Escola Paulista de Medicina, São Paulo, Brazil
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Sousa-Pinto B, Louis G, Rodrigues J, Giuliano AFM, Baiardini I, Braido F, Czarlewski W, Bedbrook A, Haahtela T, Valiulis A, Brussino L, Cecchi L, Cruz AA, Gemicioglu B, Fokkens WJ, Ivancevich JC, Klimek L, Kraxner H, Kuna P, Kupczyk M, Kvedariene V, Larenas-Linnemann D, Louis R, Nadif R, Niedoszytko M, Okamoto Y, Ollert M, Papadopoulos NG, Patella V, Pawankar R, Pham-Thi N, Pfaar O, Regateiro FS, Roche N, Rouadi PW, Samolinski B, Sastre J, Savouré M, Scichilone N, Sheikh A, Taborda-Barata L, Toppila-Salmi S, Yorgancioglu A, Zidarn M, Anto JM, Zuberbier T, Canonica GW, Ventura MT, Fonseca JA, Pétré B, Bousquet J. Impairment of EQ-5D-5L Domains According to Allergic Rhinitis and Asthma Control: A MASK-air Real-World Study. THE JOURNAL OF ALLERGY AND CLINICAL IMMUNOLOGY. IN PRACTICE 2023; 11:3742-3751.e9. [PMID: 37572753 DOI: 10.1016/j.jaip.2023.08.006] [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: 04/11/2023] [Revised: 07/31/2023] [Accepted: 08/01/2023] [Indexed: 08/14/2023]
Abstract
BACKGROUND EQ-5D-5L (EuroQOL, 5 Domains, 5 Levels) is a widely used health-related quality-of-life instrument, comprising 5 domains. However, it is not known how each domain is impacted by rhinitis or asthma control. OBJECTIVE To assess the association between rhinitis or asthma control and the different EQ-5D-5L domains using data from the MASK-air mHealth app. METHODS In this cross-sectional study, we assessed data from all MASK-air users (2015-2021; 24 countries). For the levels of each EQ-5D-5L domain, we assessed rhinitis and asthma visual analog scales (VASs) and the combined symptom-medication score (CSMS). We built ordinal multivariable models assessing the adjusted association between VAS/CSMS values and the levels of each EQ-5D-5L domain. Finally, we compared EQ-5D-5L data from users with rhinitis and self-reported asthma with data from users with rhinitis alone. RESULTS We assessed 5354 days from 3092 users. We observed an association between worse control of rhinitis or asthma (higher VASs and CSMS) and worse EQ-5D-5L levels. In multivariable models, all VASs and the CSMS were associated with higher levels of pain/discomfort and daily activities. For anxiety/depression, the association was mostly observed for rhinitis-related tools (VAS nose, VAS global, and CSMS), although the presence of self-reported asthma was also associated with worse anxiety/depression. Worse mobility ("walking around") was particularly associated with VAS asthma and with the presence of asthma. CONCLUSIONS A worse rhinitis control and a worse asthma control are associated with higher EQ-5D-5L levels, particularly regarding pain/discomfort and activity impairment. Worse rhinitis control is associated with worse anxiety/depression, and poor asthma control with worse mobility.
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Affiliation(s)
- Bernardo Sousa-Pinto
- MEDCIDS-Department of Community Medicine, Information and Health Decision Sciences, Faculty of Medicine, University of Porto, Porto, Portugal; CINTESIS@RISE-Health Research Network, Faculty of Medicine, University of Porto, Porto, Portugal
| | - Gilles Louis
- Department of Public Health, University of Liège, Liège, Belgium
| | - Jorge Rodrigues
- MEDCIDS-Department of Community Medicine, Information and Health Decision Sciences, Faculty of Medicine, University of Porto, Porto, Portugal; CINTESIS@RISE-Health Research Network, Faculty of Medicine, University of Porto, Porto, Portugal; Otorhinolaryngology Department, Centro Hospitalar Universitário de S João, EPE, Porto, Portugal; Unit of Anatomy, Department of Biomedicine, Faculty of Medicine, University of Porto, Porto, Portugal
| | - Antonio Francesco Maria Giuliano
- Department of Internal Medicine 'A. Murri' and Unit of Geriatric Immunoallergology, University of Bari Medical School, Bari, Italy
| | - Ilaria Baiardini
- Respiratory Clinic, Department of Internal Medicine, University of Genoa, Genoa, Italy; IRCCS Ospedale Policlinico San Martino, Genoa, Italy
| | - Fulvio Braido
- Respiratory Clinic, Department of Internal Medicine, University of Genoa, Genoa, Italy; IRCCS Ospedale Policlinico San Martino, Genoa, Italy
| | | | - Anna Bedbrook
- MASK-air, Montpellier, France; ARIA, Montpellier, France
| | - Tari Haahtela
- Skin and Allergy Hospital, Helsinki University Hospital, University of Helsinki, Helsinki, Finland
| | - Arunas Valiulis
- Interdisciplinary Research Group of Human Ecology, Institute of Clinical Medicine and Institute of Health Sciences, Medical Faculty of Vilnius University, Vilnius, Lithuania; European Academy of Paediatrics, (EAP/UEMS-SP), Brussels, Belgium
| | - Luisa Brussino
- Department of Medical Sciences, University of Torino, Torino, Italy; Allergy and Clinical Immunology Unit, Mauriziano Hospital, Torino, Italy
| | - Lorenzo Cecchi
- SOS Allergology and Clinical Immunology, USL Toscana Centro, Prato, Italy
| | - Alvaro A Cruz
- Fundaçao ProAR, Federal University of Bahia and GARD/WHO Planning Group, Salvador, Bahia, Brazil
| | - Bilun Gemicioglu
- Department of Pulmonary Diseases, Istanbul University-Cerrahpaşa, Cerrahpaşa Faculty of Medicine, Istanbul, Turkey
| | - Wytske J Fokkens
- Department of Otorhinolaryngology, Amsterdam University Medical Centres, Amsterdam, the Netherlands
| | | | - Ludger Klimek
- Department of Otolaryngology, Head and Neck Surgery, Universitätsmedizin Mainz, Mainz, Germany; Center for Rhinology and Allergology, Wiesbaden, Germany
| | - Helga Kraxner
- Department of Otorhinolaryngology, Head and Neck Surgery, Semmelweis University, Budapest, Hungary
| | - Piotr Kuna
- Division of Internal Medicine, Asthma and Allergy, Barlicki University Hospital, Medical University of Lodz, Lodz, Poland
| | - Maciej Kupczyk
- Division of Internal Medicine, Asthma and Allergy, Barlicki University Hospital, Medical University of Lodz, Lodz, Poland
| | - Violeta Kvedariene
- Institute of Clinical Medicine, Clinic of Chest Diseases and Allergology, Faculty of Medicine, Vilnius University, Vilnius, Lithuania; Department of Pathology, Institute of Biomedical Sciences, Faculty of Medicine, Vilnius University, Vilnius, Lithuania
| | - Désirée Larenas-Linnemann
- Center of Excellence in Asthma and Allergy, Médica Sur Clinical Foundation and Hospital, México City, Mexico
| | - Renaud Louis
- Department of Pulmonary Medicine, CHU Liège, Liège, Belgium; GIGA I3 Research Group, University of Liège, Liège, Belgium
| | - Rachel Nadif
- Université Paris-Saclay, UVSQ, Univ. Paris-Sud, Villejuif, France; Inserm, Equipe d'Epidémiologie Respiratoire Intégrative, CESP, Villejuif, France
| | - Marek Niedoszytko
- Department of Allergology, Medical University of Gdańsk, Gdansk, Poland
| | - Yoshitaka Okamoto
- Chiba Rosai Hospital, Chiba, Japan; Chiba University Hospital, Chiba, Japan
| | - Markus Ollert
- Department of Infection and Immunity, Luxembourg Institute of Health, Esch-sur-Alzette, Luxembourg; Department of Dermatology and Allergy Centre, Odense University Hospital, Odense, Denmark; Odense Research Center for Anaphylaxis (ORCA), Odense, Denmark
| | | | - Vincenzo Patella
- Division of Allergy and Clinical Immunology, Department of Medicine, "Santa Maria della Speranza" Hospital, Battipaglia, Salerno, Italy; Agency of Health ASL, Salerno, Italy; Postgraduate Programme in Allergy and Clinical Immunology, University of Naples Federico II, Naples, Italy
| | - Ruby Pawankar
- Department of Pediatrics, Nippon Medical School, Tokyo, Japan
| | - Nhân Pham-Thi
- Ecole Polytechnique de Palaiseau, Palaiseau, France; IRBA (Institut de Recherche Bio-Médicale des Armées), Brétigny sur Orge, France; Université Paris Cité, Paris, France
| | - Oliver Pfaar
- Section of Rhinology and Allergy, Department of Otorhinolaryngology, Head and Neck Surgery, University Hospital Marburg, Philipps-Universität Marburg, Marburg, Germany
| | - Frederico S Regateiro
- Allergy and Clinical Immunology Unit, Centro Hospitalar e Universitário de Coimbra, Coimbra, Portugal; Center for Innovative Biomedicine and Biotechnology (CIBB), Faculty of Medicine, University of Coimbra, Coimbra, Portugal; Institute of Immunology, Faculty of Medicine, University of Coimbra, Coimbra, Portugal; UBIAir - Clinical & Experimental Lung Centre and CICS-UBI Health Sciences Research Centre, University of Beira Interior, Covilhã, Portugal
| | - Nicolas Roche
- Pneumologie, AP-HP Centre Université de Paris Cité, Hôpital Cochin, Paris, France; UMR 1016, Institut Cochin, Paris, France
| | - Philip W Rouadi
- Department of Otolaryngology-Head and Neck Surgery, Eye and Ear University Hospital, Beirut, Lebanon; Department of Otorhinolaryngology-Head and Neck Surgery, Dar Al Shifa Hospital, Salmiya, Kuwait
| | - Boleslaw Samolinski
- Department of Prevention of Environmental Hazards, Allergology and Immunology, Medical University of Warsaw, Warsaw, Poland
| | - Joaquin Sastre
- Allergy Service, Fundacion Jimenez Diaz, Autonoma University of Madrid, CIBERES-ISCIII, Madrid, Spain
| | - Marine Savouré
- Université Paris-Saclay, UVSQ, Univ. Paris-Sud, Villejuif, France; Inserm, Equipe d'Epidémiologie Respiratoire Intégrative, CESP, Villejuif, France
| | | | - Aziz Sheikh
- Usher Institute, the University of Edinburgh, Edinburgh, United Kingdom
| | - Luís Taborda-Barata
- Department of Immunoallergology, Cova da Beira University Hospital Centre, Covilhã, Portugal; UBIAir-Clinical & Experimental Lung Centre and CICS-UBI Health Sciences Research Centre, University of Beira Interior, Covilhã, Portugal
| | - Sanna Toppila-Salmi
- Skin and Allergy Hospital, Helsinki University Hospital, University of Helsinki, Helsinki, Finland
| | - Arzu Yorgancioglu
- Department of Pulmonary Diseases, Celal Bayar University, Faculty of Medicine, Manisa, Turkey
| | - Mihaela Zidarn
- University Clinic of Respiratory and Allergic Diseases, Golnik, Slovenia; University of Ljubljana, Faculty of Medicine, Ljubljana, Slovenia
| | - Josep M Anto
- ISGlobal, Barcelona Institute for Global Health, Barcelona, Spain; Universitat Pompeu Fabra (UPF), Barcelona, Spain; CIBER Epidemiología y Salud Pública (CIBERESP), Barcelona, Spain
| | - Torsten Zuberbier
- Fraunhofer Institute for Translational Medicine and Pharmacology ITMP, Allergology and Immunology, Berlin, Germany; Institute of Allergology, Charité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany
| | - G Walter Canonica
- Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Milan, Italy; IRCCS Humanitas Research Hospital, Rozzano, Milan, Italy
| | - Maria Teresa Ventura
- Department of Internal Medicine 'A. Murri' and Unit of Geriatric Immunoallergology, University of Bari Medical School, Bari, Italy; Institute of Sciences of Food Production, National Research Council (ISPA-CNR), Bari, Italy
| | - João A Fonseca
- MEDCIDS-Department of Community Medicine, Information and Health Decision Sciences, Faculty of Medicine, University of Porto, Porto, Portugal; CINTESIS@RISE-Health Research Network, Faculty of Medicine, University of Porto, Porto, Portugal
| | - Benoit Pétré
- Department of Public Health, University of Liège, Liège, Belgium
| | - Jean Bousquet
- Fraunhofer Institute for Translational Medicine and Pharmacology ITMP, Allergology and Immunology, Berlin, Germany; Institute of Allergology, Charité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany.
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Zheng P, Liu X, Lin L, Wu H, Zhao X, Sun B. Efficacy of mite allergen immunotherapy in allergic rhinitis and the immune synergistic effect on cross-allergens. Immunotherapy 2021; 14:217-233. [PMID: 34845913 DOI: 10.2217/imt-2020-0326] [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] [Indexed: 11/21/2022] Open
Abstract
Aim: To compare the efficacy of single- and double-species mite allergen immunotherapy. Materials and methods: An open, pseudo-randomized, controlled study was conducted (n = 125 allergic rhinitis patients). The primary end point involved the visual analogue scale. Secondary end points included a basophil activation test and serum specific IgE and IgG4 assays. Results: Visual analogue scale analysis indicated considerable reductions in both groups. Both treatments improved quality of life and induced sIgG4 antibody production. Basophil activation and serum IgE inhibition were not evident in either treatment. Neither treatment displayed an early stage immune synergistic effect on cross-allergens. Conclusions: Both treatments were effective against allergic rhinitis, and statistical differences were not observed. Future studies may require long-term, large-scale research.
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Affiliation(s)
- Peiyan Zheng
- Department of Allergy & Clinical Immunology, State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, National Center for Respiratory Medicine, Guangzhou Institute of Respiratory Health, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, 510120, China
| | - Xiaoqing Liu
- Department of Clinical Laboratory, Zhuhai People's Hospital (Zhuhai hospital affiliated with Jinan University), Zhuhai, 519070, China
| | - Lili Lin
- Department of Otolaryngology Head & Neck Surgery, Zhuhai People's Hospital (Zhuhai hospital affiliated with Jinan University), Zhuhai, 519070, China
| | - Huiqin Wu
- Department of Otolaryngology Head & Neck Surgery, Zhuhai People's Hospital (Zhuhai hospital affiliated with Jinan University), Zhuhai, 519070, China
| | - Xiaoming Zhao
- Department of Otolaryngology Head & Neck Surgery, Zhuhai People's Hospital (Zhuhai hospital affiliated with Jinan University), Zhuhai, 519070, China
| | - Baoqing Sun
- Department of Allergy & Clinical Immunology, State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, National Center for Respiratory Medicine, Guangzhou Institute of Respiratory Health, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, 510120, China
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Metabolomics Reveals Process of Allergic Rhinitis Patients with Single- and Double-Species Mite Subcutaneous Immunotherapy. Metabolites 2021; 11:metabo11090613. [PMID: 34564431 PMCID: PMC8471092 DOI: 10.3390/metabo11090613] [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] [Received: 07/08/2021] [Revised: 09/03/2021] [Accepted: 09/06/2021] [Indexed: 01/08/2023] Open
Abstract
Allergen immunotherapy (AIT) is the only treatment that can change the course of allergic diseases. However, there has not been any research on metabolic reactions in relation to AIT with single or mixed allergens. In this study, patients with allergic rhinitis caused by Dermatophagoides pteronyssinus (Der p) and Dermatophagoides farinae (Der f) were treated with single-mite (Der p) and double-mite (Der p:Der f = 1:1) subcutaneous immunotherapy (SCIT), respectively. To compare the efficacy and the dynamic changes of inflammation-related single- and double-species mite subcutaneous immunotherapy (SM-SCIT and DM-SCIT), we performed visual analogue scale (VAS) score, rhinoconjunctivitis quality of life questionnaire (RQLQ) score and serum metabolomics in allergic rhinitis patients during SCIT. VAS and RQLQ score showed no significant difference in efficacy between the two treatments. A total of 57 metabolites were identified, among which downstream metabolites (5(S)-HETE (Hydroxyeicosatetraenoic acid), 8(S)-HETE, 11(S)-HETE, 15(S)-HETE and 11-hydro TXB2) in the ω-6-related arachidonic acid and linoleic acid pathway showed significant differences after approximately one year of treatment in SM-SCIT or DM-SCIT, and the changes of the above serum metabolic components were correlated with the magnitude of RQLQ improvement, respectively. Notably, 11(S)-HETE decreased more with SM-SCIT, and thus it could be used as a potential biomarker to distinguish the two treatment schemes. Both SM-SCIT and DM-SCIT have therapeutic effects on patients with allergic rhinitis, but there is no significant difference in efficacy between them. The reduction of inflammation-related metabolites proved the therapeutic effect, and potential biomarkers (arachidonic acid and its downstream metabolites) may distinguish the options of SCIT.
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Tabar AI, Delgado J, González-Mancebo E, Arroabarren E, Soto Retes L, Domínguez-Ortega J. Recent Advances in Allergen-Specific Immunotherapy as Treatment for Allergic Asthma: A Practical Overview. Int Arch Allergy Immunol 2021; 182:496-514. [PMID: 33631755 DOI: 10.1159/000513811] [Citation(s) in RCA: 6] [Impact Index Per Article: 1.5] [Reference Citation Analysis] [Abstract] [Key Words] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/02/2020] [Accepted: 12/11/2020] [Indexed: 11/19/2022] Open
Abstract
The Global Initiative for Asthma Report updated in 2019 stated that potential benefits of allergen immunotherapy (AIT), compared to pharmacological and avoidance options, must be weighed against the risk of adverse effects and the inconvenience and cost of the prolonged course of therapy in asthma. Thus, with the aim of clarifying some aspects with regard to the possible use of AIT in allergic asthma treatment armamentarium, a group of expert allergists from the Spanish Allergy and Clinical Immunology Scientific Society (SEAIC), particularly from the Immunotherapy and Asthma Interest Groups developed a frequently asked questions in clinical practice. This document updates relevant topics on the use of AIT in asthma and could facilitate physician clinical decisions and improve health outcomes for individual patients.
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Affiliation(s)
- Ana I Tabar
- Department of Allergy, Hospital Complex of Navarra, Pamplona, Spain, .,Navarra Institute for Health Research (IdiSNA), Cooperative Health Research Thematic Networks (RETICs) for Asthma, Adverse Reactions to Drugs, and Allergy (ARADYAL) Research Network, Pamplona, Spain,
| | - Julio Delgado
- Clinical Management for Allergy Unit, University Hospital Virgen Macarena, Seville, Spain
| | - Eloina González-Mancebo
- Department of Allergy, University Hospital Fuenlabrada, La Paz Hospital Institute for Health Research (IdiPAZ), Madrid, Spain.,Cooperative Health Research Thematic Networks (RETICs) for Asthma, Adverse Reactions to Drugs and Allergy (ARADYAL) Research Network, Madrid, Spain
| | | | - Lorena Soto Retes
- Department of Pneumology and Allergy, Santa Creu i Sant Pau Hospital, Barcelona, Spain.,Department of Medicine, Sant Pau Biomedical Research Institute (IIB Sant Pau), Autonomous University of Barcelona (UAB), Barcelona, Spain
| | - Javier Domínguez-Ortega
- Department of Allergy, La Paz Hospital Institute for Health Research (IdiPAZ), CIBER of Respiratory Diseases, CIBERES, Madrid, Spain
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Retzler J, Grand TS, Domdey A, Smith A, Romano Rodriguez M. Utility elicitation in adults and children for allergic rhinoconjunctivitis and associated health states. Qual Life Res 2018; 27:2383-2391. [PMID: 29948599 PMCID: PMC6132982 DOI: 10.1007/s11136-018-1910-8] [Citation(s) in RCA: 8] [Impact Index Per Article: 1.1] [Reference Citation Analysis] [Abstract] [Key Words] [Download PDF] [Journal Information] [Subscribe] [Scholar Register] [Accepted: 06/05/2018] [Indexed: 12/02/2022]
Abstract
Purpose Allergic rhinitis and asthma symptoms are detrimental to health-related quality of life (HRQoL). Health technology appraisal agencies often require cost–utility analysis when assessing new interventions. Appropriate utility estimates, which quantify the value of different conditions in cost–utility analyses, are scarce for allergic rhinitis and asthma health states. This study aimed to generate utilities for allergic rhinitis and asthma health states from a European general population sample of adults and children. Methods Health state descriptions incorporating symptoms, impact of symptoms on daily life and symptom treatment were developed using clinical guidelines. Descriptions were amended with clinician and patient input, and incorporated into a survey in which each health state was followed by a standard gamble (adults) or visual analogue scale (children) item. The survey was distributed to samples of adults and children aged 8 to 11 from four European countries that were stratified to represent the general population within that country. Results 1454 adults and 1082 children completed the survey. Mean health utilities ranged from 0.635 to 0.880 and those elicited in children were lower (0.635 to 0.705) than those elicited in adults (0.812 to 0.880). Disutilities assessing the impact of increased allergic rhinitis severity and comorbidities were also greater in children than in adults. Conclusions Symptoms of allergic rhinitis and asthma were valued as having a clinically meaningful impact on HRQoL. Children valued health states as poorer than adults, and further research should investigate whether this reflects true preferential differences or results from methodological and/or comprehension differences between the two groups. Electronic supplementary material The online version of this article (10.1007/s11136-018-1910-8) contains supplementary material, which is available to authorized users.
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Affiliation(s)
- Jenny Retzler
- York Health Economics Consortium, Enterprise House, University of York, Innovation Way, York, YO10 5NQ, UK.
| | | | | | - Adam Smith
- York Health Economics Consortium, Enterprise House, University of York, Innovation Way, York, YO10 5NQ, UK
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Schwanke T, Carragee E, Bremberg M, Reisacher WR. Quality-of-life outcomes in patients who underwent subcutaneous immunotherapy and sublingual immunotherapy in a real-world clinical setting. Am J Rhinol Allergy 2018; 31:310-316. [PMID: 28859707 DOI: 10.2500/ajra.2017.31.4465] [Citation(s) in RCA: 6] [Impact Index Per Article: 0.9] [Reference Citation Analysis] [Abstract] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 01/01/2023]
Abstract
OBJECTIVE To compare changes in quality of life (QOL) that resulted from sublingual immunotherapy (SLIT) and subcutaneous immunotherapy (SCIT) in a real-world clinical setting. BACKGROUND SLIT is established as a viable alternative to SCIT for the treatment of allergic rhinitis. Although comparative trials are increasingly available, few studies have examined QOL outcomes between these two treatments. METHODS One hundred and five participants who underwent immunotherapy for airborne allergies were enrolled in this prospective, single-center study. Forty participants completed the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) at initiation of therapy, after 6 months, and after 1 year of therapy. Only patients with complete time points were included in the ultimate analysis. Twenty-nine of these participants underwent SCIT and 11 underwent SLIT. The effects of age, sex, and asthma history were also examined. RESULTS The participants in both groups demonstrated improvements in QOL regarding allergic rhinoconjunctivitis over the study period. However, the change in the RQLQ score from both baseline to 6 months and baseline to 1 year was only statistically significant in the SCIT group (p = 0.002, 6 months and 1 year). The participants in the SCIT group also demonstrated statistically significant improvement from baseline to 1 year in the specific domains of practical and emotional functioning, nasal symptoms, non-nasal/eye symptoms, and sleep. After 1 year, both SCIT and SLIT demonstrated a minimally important difference from baseline in the overall RQLQ score. Age <35 years in the SCIT group had a significant positive impact on QOL improvement (p = 0.038). CONCLUSION Although improvements in QOL were noted in both groups, changes in overall scores and the majority of domains only achieved statistical significance in the SCIT group. A small study population and difficulties adhering to immunotherapy dosing schedules in the SLIT group may be contributing factors.
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Affiliation(s)
- Theresa Schwanke
- Department of Otolaryngology-Head and Neck Surgery, Weill Cornell Medical College, New York, New York, USA
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9
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Westwood M, Ramaekers B, Lang S, Armstrong N, Noake C, de Kock S, Joore M, Severens J, Kleijnen J. ImmunoCAP® ISAC and Microtest for multiplex allergen testing in people with difficult to manage allergic disease: a systematic review and cost analysis. Health Technol Assess 2018; 20:1-178. [PMID: 27623692 DOI: 10.3310/hta20670] [Citation(s) in RCA: 26] [Impact Index Per Article: 3.7] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/24/2022] Open
Abstract
BACKGROUND Allergy is a form of immune-mediated exaggerated sensitivity (hypersensitivity) to a substance that is either inhaled, swallowed, injected or comes into contact with the skin. Foreign substances that provoke allergies are called allergens. It has been claimed that multiplex allergen testing may help in diagnosing the cause of symptoms in patients with an unclear cause of allergy or who are allergic to more than one substance. OBJECTIVES To evaluate multiplex allergen testing [devices that can measure the presence of multiple immunoglobulin E (IgE) antibodies in a patient's blood at the same time], by assessing (1) clinical effectiveness (allergy symptoms, incidence of acute exacerbations, mortality, adverse events of testing and treatment, health-care presentations or admissions, health-related quality of life); (2) effects on treatment (diet, immunotherapy medications, other potential testing); (3) any additional diagnostic information provided by multiplex allergen testing; and (4) cost-effectiveness (cost of different assessment strategies). METHODS Fifteen databases were searched from 2005 to April 2015, including MEDLINE (via OvidSp), MEDLINE In-Process Citations, MEDLINE Daily Update, PubMed (National Library of Medicine), EMBASE, Cochrane Database of Systematic Reviews (CDSR), Cochrane Central Register of Controlled Trials (CENTRAL), Database of Abstracts of Reviews of Effects (DARE), Health Technology Assessment (HTA) database, Science Citation Index (SCI), Conference Proceedings Citation Index-Science (CPCI-S), BIOSIS Previews, Latin American and Caribbean Health Sciences Literature (LILACS), National Institute for Health Research (NIHR) HTA programme, and the US Food and Drug Administration (FDA); supplementary searches of conference proceedings and trials registries were performed. Review methods followed published guidance from the Cochrane Collaboration and the Centre for Reviews and Dissemination, University of York, UK. The methodological quality of included studies was assessed using appropriate published tools or a review-specific tool designed by the project team. Studies were summarised in a narrative synthesis. Owing to a lack of data on the clinical effectiveness of multiplex allergen testing, no long-term cost-effectiveness model was developed. A conceptual model structure was developed and cost analyses were performed to examine the short-term costs of various possible diagnostic pathways. RESULTS Fifteen studies were included in the review. The very limited available data indicated that the addition of multiplex allergen testing [ImmunoCAP(®) Immuno Solid-phase Allergen Chip (ISAC), Thermo Fisher Scientific/Phadia AB, Uppsala, Sweden] to standard diagnostic work-up can change the clinicians' views on the diagnosis, management and treatment of patients. There was some indication that the use of ImmunoCAP ISAC testing may be useful to guide decisions on the discontinuation of restrictive diets, the content of allergen-specific immunotherapy (SIT) prescriptions, and whether or not patients should receive SIT. However, none of the studies that we identified reported any information on clinical outcomes subsequent to changes in treatment or management. There was some evidence that ImmunoCAP ISAC may be useful for discriminating allergens that are structurally similar and are recognised by the same IgE antibody (cross-immunoreactive). No data were available for Microtest (Microtest Matrices Ltd, London, UK). Detailed cost analyses suggested that multiplex allergen testing would have to result in a substantial reduction of the proportions of patients receiving single IgE testing and oral food challenge tests in order to be cost-saving in the short term. CONCLUSIONS No recommendations for service provision can be made based on the analyses included in this report. It is suggested that a consensus-based protocol for the use of multiplex allergen testing be developed. The clinical effectiveness and cost-effectiveness of the proposed protocol should then be assessed by comparing long-term clinical and quality of life outcomes and resource use in patients managed using the protocol with those managed using a standard diagnostic pathway. STUDY REGISTRATION This study is registered as PROSPERO CRD42015019739. FUNDING This project was a Diagnostic Assessment Report commissioned by the NIHR HTA programme on behalf of the National Institute for Health and Care Excellence.
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Affiliation(s)
| | - Bram Ramaekers
- Department of Clinical Epidemiology and Medical Technology Assessment, Maastricht University Medical Centre, Maastricht, The Netherlands
| | - Shona Lang
- Kleijnen Systematic Reviews Ltd, York, UK
| | | | - Caro Noake
- Kleijnen Systematic Reviews Ltd, York, UK
| | | | - Manuela Joore
- Department of Clinical Epidemiology and Medical Technology Assessment, Maastricht University Medical Centre, Maastricht, The Netherlands
| | - Johan Severens
- Institute of Health Policy and Management, Erasmus University Rotterdam, Rotterdam, The Netherlands
| | - Jos Kleijnen
- School for Public Health and Primary Care (CAPHRI), Maastricht University, Maastricht, The Netherlands
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10
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Bousquet J, Arnavielhe S, Bedbrook A, Fonseca J, Morais Almeida M, Todo Bom A, Annesi-Maesano I, Caimmi D, Demoly P, Devillier P, Siroux V, Menditto E, Passalacqua G, Stellato C, Ventura MT, Cruz AA, Sarquis Serpa F, da Silva J, Larenas-Linnemann D, Rodriguez Gonzalez M, Burguete Cabañas MT, Bergmann KC, Keil T, Klimek L, Mösges R, Shamai S, Zuberbier T, Bewick M, Price D, Ryan D, Sheikh A, Anto JM, Mullol J, Valero A, Haahtela T, Valovirta E, Fokkens WJ, Kuna P, Samolinski B, Bindslev-Jensen C, Eller E, Bosnic-Anticevich S, O'Hehir RE, Tomazic PV, Yorgancioglu A, Gemicioglu B, Bachert C, Hellings PW, Kull I, Melén E, Wickman M, van Eerd M, De Vries G. The Allergic Rhinitis and its Impact on Asthma (ARIA) score of allergic rhinitis using mobile technology correlates with quality of life: The MASK study. Allergy 2018; 73:505-510. [PMID: 28906011 DOI: 10.1111/all.13307] [Citation(s) in RCA: 61] [Impact Index Per Article: 8.7] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Accepted: 09/07/2017] [Indexed: 01/06/2023]
Abstract
Mobile technology has been used to appraise allergic rhinitis control, but more data are needed. To better assess the importance of mobile technologies in rhinitis control, the ARIA (Allergic Rhinitis and its Impact on Asthma) score ranging from 0 to 4 of the Allergy Diary was compared with EQ-5D (EuroQuol) and WPAI-AS (Work Productivity and Activity Impairment in allergy) in 1288 users in 18 countries. This study showed that quality-of-life data (EQ-5D visual analogue scale and WPA-IS Question 9) are similar in users without rhinitis and in those with mild rhinitis (scores 0-2). Users with a score of 3 or 4 had a significant impairment in quality-of-life questionnaires.
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Affiliation(s)
- J. Bousquet
- MACVIA-France; Contre les MAladies Chroniques Pour un VIeillissement Actif en France European Innovation Partnership on Active and Healthy Ageing Reference Site; 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
| | | | - A. Bedbrook
- MACVIA-France; Contre les MAladies Chroniques Pour un VIeillissement Actif en France European Innovation Partnership on Active and Healthy Ageing Reference Site; Montpellier France
| | - J. Fonseca
- Faculdade de Medicina; Center for Health Technology and Services Research- CINTESIS; Universidade do Porto; Porto Portugal
- Allergy Unit; CUF Porto Instituto & Hospital; Porto Portugal
| | | | - A. Todo Bom
- Faculty of Medicine; Imunoalergologia; Centro Hospitalar Universitário de Coimbra; University of Coimbra; Coimbra Portugal
| | | | - D. Caimmi
- UPMC Paris 06, UMR-S 1136, IPLESP, Equipe EPAR; CHRU de Montpellier; Sorbonne Universités; Paris France
| | - P. Demoly
- UPMC Paris 06, UMR-S 1136, IPLESP, Equipe EPAR; CHRU de Montpellier; Sorbonne Universités; Paris France
| | - P. Devillier
- Laboratoire de Pharmacologie Respiratoire UPRES EA220; Pôle des Maladies Respiratoires; Hôpital Foch; Université Versailles Saint-Quentin; Suresnes France
| | - V. Siroux
- INSERM, IAB, U 1209; Team of Environmental Epidemiology Applied to Reproduction and Respiratory Health; Université Joseph Fourier; Université Grenoble Alpes; Grenoble France
| | - E. Menditto
- CIRFF; Center of Pharmacoeconomics; University of Naples Federico II; Naples Italy
| | - G. Passalacqua
- Personalized Medicine Clinic Asthma & Allergy; Humanitas Research Hospital; Humanitas University; Milan Italy
| | - C. Stellato
- Department of Medicine, Surgery and Dentistry “Scuola Medica Salernitana”; University of Salerno; Salerno Italy
| | - M. T. Ventura
- Unit of Geriatric Immunoallergology; University of Bari Medical School; Bari Italy
| | - A. A. Cruz
- ProAR - Nucleo de Excelencia em Asma, Brasil and GARD Executive Committee; Federal University of Bahia; Salvador Brazil
| | - F. Sarquis Serpa
- Asthma Reference Center; Escola Superior de Ciencias da Santa Casa de Misericordia de Vitoria; Vitória Brazil
| | - J. da Silva
- Allergy Service; University Hospital of Federal University of Santa Catarina (HU-UFSC); Florianopolis Brazil
| | | | - M. Rodriguez Gonzalez
- Pediatric Allergy and Clinical Immunology, Hospital Angeles Pedregal; Mexico City Mexico
| | | | - K. C. Bergmann
- Comprehensive Allergy-Centre-Charité; Department of Dermatology and Allergy; Charité - Universitätsmedizin Berlin; Berlin Germany
- Global Allergy and Asthma European Network (GA LEN); Berlin Germany
| | - T. Keil
- Institute of Social Medicine, Epidemiology and Health Economics; Charité - Universitätsmedizin Berlin; Berlin Germany
- Institute for Clinical Epidemiology and Biometry; University of Wuerzburg; Wuerzburg Germany
| | - L. Klimek
- Center for Rhinology and Allergology; Wiesbaden Germany
| | - R. Mösges
- Medical Faculty; Institute of Medical Statistics, Informatics and Epidemiology; University of Cologne; Cologne Germany
| | - S. Shamai
- Medical Faculty; Institute of Medical Statistics, Informatics and Epidemiology; University of Cologne; Cologne Germany
| | - T. Zuberbier
- Comprehensive Allergy-Centre-Charité; Department of Dermatology and Allergy; Charité - Universitätsmedizin Berlin; Berlin Germany
- Global Allergy and Asthma European Network (GA LEN); Berlin Germany
| | | | - D. Price
- Observational and Pragmatic Research Institute; Singapore Singapore
- Optimum Patient Care; Cambridge UK
- Academic Centre of Primary Care; University of Aberdeen; Aberdeen UK
| | - D. Ryan
- Allergy and Respiratory Research Group; Usher Institute of Population Health Sciences and Informatics; University of Edinburgh; Edinburgh UK
| | - A. Sheikh
- Asthma UK Centre for Applied Research; Centre of Medical Informatics; Usher Institute of Population Health Sciences and Informatics; The University of Edinburgh; Edinburgh UK
| | - J. M. Anto
- Centre for Research in Environmental Epidemiology (CREAL); ISGLoBAL; Barcelona Spain
- IMIM (Hospital del Mar Research Institute); Barcelona Spain
- CIBER Epidemiología y Salud Pública (CIBERESP) & Universitat Pompeu Fabra (UPF); Barcelona Spain
| | - J. Mullol
- Allergy Center; CUF-Descobertas Hospital; Lisboa Portugal
| | - A. Valero
- Pneumology and Allergy Department Hospital Clínic; Clinical & Experimental Respiratory Immunoallergy; IDIBAPS, CIBERES; University of Barcelona; Barcelona Spain
| | - T. Haahtela
- Skin and Allergy Hospital; Helsinki University Hospital; Helsinki Finland
| | - E. Valovirta
- Pneumology and Allergy Department Hospital Clínic; Clinical & Experimental Respiratory Immunoallergy; IDIBAPS, CIBERES; University of Barcelona; Barcelona Spain
| | - W. J. Fokkens
- Department of Otorhinolaryngology; Academic Medical Centre; Amsterdam the Netherlands
| | - P. Kuna
- Division of Internal Medicine, Asthma and Allergy; Barlicki University Hospital; Medical University of Lodz; Lodz Poland
| | - B. Samolinski
- Department of Prevention of Environmental Hazards and Allergology; Medical University of Warsaw Poland
| | - C. Bindslev-Jensen
- Department of Dermatology and Allergy Centre; Odense University Hospital; Odense Research Center for Anaphylaxis (ORCA); Odense Denmark
| | - E. Eller
- Department of Dermatology and Allergy Centre; Odense University Hospital; Odense Research Center for Anaphylaxis (ORCA); Odense Denmark
| | - S. Bosnic-Anticevich
- Woolcock Institute of Medical Research; University of Sydney and Sydney Local Health District; Glebe NSW Australia
| | - R. E. O'Hehir
- Department of Allergy, Immunology and Respiratory Medicine; Alfred Hospital and Central Clinical School; Monash University; Melbourne VIC Australia
- Department of Immunology; Monash University; Melbourne VIC Australia
| | - P. V. Tomazic
- Department of ENT; Medical University of Graz; Graz Austria
| | - A. Yorgancioglu
- Department of Pulmonology; Celal Bayar University; Manisa Turkey
- GARD Executive Committee; Manisa Turkey
| | - B. Gemicioglu
- Cerrahpasa Faculty of Medicine; Department of Pulmonary Diseases; Istanbul University; Istanbul Turkey
| | - C. Bachert
- Upper Airways Research Laboratory; ENT Department; Ghent University Hospital; Ghent Belgium
| | - P. W. Hellings
- Laboratory of Clinical Immunology; Department of Microbiology and Immunology; KU Leuven; Leuven Belgium
| | - I. Kull
- Department of Clinical Science and Education; Södersjukhuset; Karolinska Institutet; Stockholm Sweden
| | - E. Melén
- Department of Clinical Science and Education; Södersjukhuset; Karolinska Institutet; Stockholm Sweden
| | - M. Wickman
- Sachs’ Children and Youth Hospital; Södersjukhuset, Stockholm and Institute of Environmental Medicine; Karolinska Institutet; Stockholm Sweden
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11
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Green W, Kleine-Tebbe J, Klimek L, Hahn-Pedersen J, Nørgaard Andreasen J, Taylor M. Cost-effectiveness of SQ ® HDM SLIT-tablet in addition to pharmacotherapy for the treatment of house dust mite allergic rhinitis in Germany. CLINICOECONOMICS AND OUTCOMES RESEARCH 2017; 9:77-84. [PMID: 28243132 PMCID: PMC5317265 DOI: 10.2147/ceor.s115931] [Citation(s) in RCA: 7] [Impact Index Per Article: 0.9] [Reference Citation Analysis] [Abstract] [Key Words] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/23/2022] Open
Abstract
Background Allergic rhinitis is a global health problem that burdens society due to associated health care costs and its impact on health. Standardized quality (SQ®) house dust mite (HDM) sublingual immunotherapy (SLIT)-tablet is a sublingually administered allergy immunotherapy tablet for patients with persistent moderate to severe HDM allergic rhinitis despite use of allergy pharmacotherapy. Objective To assess the cost-effectiveness of SQ HDM SLIT-tablet in Germany for patients suffering from HDM allergic rhinitis. Methods A pharmacoeconomic analysis, based on data collected in a double-blinded, phase III randomized placebo-controlled trial (n=992), was undertaken to compare SQ HDM SLIT-tablet in addition to allergy pharmacotherapy to placebo plus allergy pharmacotherapy. Quality-adjusted life year (QALY) scores and health care resource use data recorded in the trial were applied to each treatment group and extrapolated over a nine-year time horizon. A series of scenarios were used to investigate the impact of changes on long-term patient health for both treatment groups, which was measured by annual changes in QALY scores. Deterministic and probabilistic sensitivity analyses were also performed. Results In the base case analysis, compared with allergy pharmacotherapy, SQ HDM SLIT-tablet led to a QALY gain of 0.31 at an incremental cost of €2,276 over the nine-year time horizon, equating to an incremental cost-effectiveness ratio of €7,519. The treatment was cost-effective for all scenarios analyzed; however, results were sensitive to changes in individual parameter values during the deterministic sensitivity analysis. Conclusion SQ HDM SLIT-tablet in addition to pharmacotherapy is cost-effective compared with allergy pharmacotherapy plus placebo for the treatment of persistent moderate to severe HDM allergic rhinitis that is not well controlled by allergy pharmacotherapy.
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Affiliation(s)
- William Green
- York Health Economics Consortium, University of York, York, UK
| | | | - Ludger Klimek
- Center for Rhinology and Allergology, Wiesbaden, Germany
| | | | | | - Matthew Taylor
- York Health Economics Consortium, University of York, York, UK
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12
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Linneberg A, Dam Petersen K, Hahn-Pedersen J, Hammerby E, Serup-Hansen N, Boxall N. Burden of allergic respiratory disease: a systematic review. Clin Mol Allergy 2016; 14:12. [PMID: 27708552 PMCID: PMC5041537 DOI: 10.1186/s12948-016-0049-9] [Citation(s) in RCA: 78] [Impact Index Per Article: 8.7] [Reference Citation Analysis] [Abstract] [Key Words] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/02/2016] [Accepted: 09/22/2016] [Indexed: 11/22/2022] Open
Abstract
This meta-analysis compared the health-related quality of life (HRQL) of patients with allergic rhinitis (AR) and/or allergic asthma (AA) caused by perennial house dust mite (HDM) versus AR and/or AA caused by seasonal pollen allergy. Following a systematic search, the identified studies used the disease-specific rhinitis quality of life questionnaire or generic instruments (SF-36 and SF-12). Summary estimates obtained by meta-analysis showed that HRQL in patients with perennial HDM allergy was significantly worse than that of patients with seasonal pollen allergy, when measured by both disease-specific and generic HRQL instruments, and was reflected by an impact on both physical and mental health. A systematic review of cost data on AR and AA in selected European countries demonstrated that the majority of the economic burden was indirectly caused by high levels of absenteeism and presenteeism; there was little or no evidence of increasing or decreasing cost trends. Increased awareness of the detrimental effects of AR and/or AA on patients’ HRQL and its considerable cost burden might encourage early diagnosis and treatment, in order to minimize the disease burden and ensure beneficial and cost-effective outcomes.
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Affiliation(s)
- A Linneberg
- Research Centre for Prevention and Health, The Capital Region of Denmark, Copenhagen, Denmark ; Department of Clinical Experimental Research, Rigshospitalet, Copenhagen, Denmark ; Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark
| | - K Dam Petersen
- Department of Business and Management, Faculty of Social Sciences, Aalborg University, Aalborg, Denmark
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13
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Larsson O, Hellkvist L, Peterson-Westin U, Cardell LO. Novel strategies for the treatment of grass pollen-induced allergic rhinitis. Expert Opin Biol Ther 2016; 16:1143-50. [PMID: 27269991 DOI: 10.1080/14712598.2016.1190829] [Citation(s) in RCA: 5] [Impact Index Per Article: 0.6] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/31/2022]
Abstract
INTRODUCTION Allergic rhinitis (AR) affects over 20% of the population of Europe and the United States. Allergen immunotherapy (AIT) is currently the only form of treatment that affects symptoms and modifies the progression of disease. Established forms of AIT include subcutaneous (SCIT) and sublingual (SLIT) immunotherapy and are widely effective, yet only 2-9% of eligible patients undergo therapy, likely due to the long duration of treatment. As a result, novel, faster forms of AIT are currently under development. AREAS COVERED This article provides an overview of AR and summarises the efficacy and mechanisms of established forms of AIT, highlighting the current drawbacks. We discuss novel strategies of AIT that have been developed in an attempt to tackle these limitations, including epicutaneous, intradermal and intralymphatic immunotherapy (ILIT), focusing on ILIT, the treatment that has been most comprehensively assessed. EXPERT OPINION Current strategies to treat AR suffer from a poor safety profile and, importantly, lack of adherence. ILIT is a faster and safer form of AIT, with a treatment regime of only 12 weeks. Further validation is required, but ILIT, with its short and comparatively inexpensive protocol, has the potential to offer disease-modifying therapy to a larger number of patients.
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Affiliation(s)
- Olivia Larsson
- a Division of ENT Diseases, Department of Clinical Sciences, Intervention and Technology , Karolinska Institutet , Stockholm , Sweden
| | - Laila Hellkvist
- a Division of ENT Diseases, Department of Clinical Sciences, Intervention and Technology , Karolinska Institutet , Stockholm , Sweden
| | - Ulla Peterson-Westin
- b Laboratory of Clinical Experimental Allergy Research, Department of Otorhinolaryngology Malmö , Lund University, Skåne University Hospital , Malmö , Sweden
| | - Lars Olaf Cardell
- a Division of ENT Diseases, Department of Clinical Sciences, Intervention and Technology , Karolinska Institutet , Stockholm , Sweden.,c Department of ENT Diseases , Karolinska University Hospital , Stockholm , Sweden
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14
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Schaffer FM, Garner LM, Ebeling M, Adelglass JM, Hulsey TC, Naples AR. The efficacy assessment of a self-administered immunotherapy protocol. Int Forum Allergy Rhinol 2015; 6:148-55. [PMID: 26467843 PMCID: PMC4860610 DOI: 10.1002/alr.21653] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/05/2015] [Revised: 06/26/2015] [Accepted: 08/18/2015] [Indexed: 01/19/2023]
Abstract
Background We previously reported the safety of a self‐administered subcutaneous immunotherapy (SCIT) protocol. Here we report the results of the retrospective efficacy trial of the United Allergy Service (UAS) self‐administered SCIT protocol. We hypothesized that by utilizing a slow SCIT buildup phase, designed to attain recommended allergen concentrations on a cumulative basis, efficacious outcomes and clinical relevance would be achieved. Methods We enrolled 60 SCIT patients and 56 control patients. The study contrasted baseline and treatment period combined symptom plus medication scores (CSMS) as the primary outcome measure and rhinoconjunctivitis quality of life questionnaire (RQLQ) scores as the secondary study outcome measure. Changes in pollen counts were also examined with regard to effects on these efficacy parameters. Results The treatment group showed significantly improved CSMS (standardized mean difference [SMD]: −1.57; 95% confidence interval [CI], −1.97 to −1.18; p < 0.001) and RQLQ (SMD: −0.91; 95% CI, −1.23 to −0.59; p < 0.001). These treatment group outcome measures were respectively improved by 33% and 29% compared to baseline and greater than 40% in comparison to the control group (p < 0.0001). Significant results were also shown when examining these outcome measures with regards to either monotherapy or poly‐allergen SCIT. Furthermore, a comparison to recent meta‐analyses of SCIT studies showed equivalent efficacy and clinical relevance. Assessment of pollen counts during the baseline and treatment periods further corroborated the efficacy of the UAS SCIT protocol. Conclusion These efficacy results, and our previous safety results, show that a carefully designed and implemented self‐administered SCIT protocol is efficacious and safe.
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Affiliation(s)
- Frederick M Schaffer
- United Allergy Services (UAS), San Antonio, TX.,Division of Pediatric Pulmonary, Allergy and Immunology, Medical University of South Carolina, Charleston, SC
| | | | - Myla Ebeling
- Division of Pediatric Epidemiology, Medical University of South Carolina, Charleston, SC
| | | | - Thomas C Hulsey
- Division of Pediatric Epidemiology, Medical University of South Carolina, Charleston, SC
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Sandrini A, Rolland JM, O'Hehir RE. Current developments for improving efficacy of allergy vaccines. Expert Rev Vaccines 2015; 14:1073-87. [PMID: 26013124 DOI: 10.1586/14760584.2015.1050385] [Citation(s) in RCA: 18] [Impact Index Per Article: 1.8] [Reference Citation Analysis] [Abstract] [Key Words] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/08/2022]
Abstract
Allergic diseases are prevalent worldwide. Allergen immunotherapy (AIT) is a current treatment for allergy, leading to modification of the natural course of disease. Mechanisms of efficacy include Treg through release of IL-10 and TGF-β and specific IgG4 blocking antibodies. Subcutaneous and sublingual routes are popular, but uptake is limited by inconvenience and safety concerns. Inclusion criteria limit application to a small proportion of allergic patients. New forms of immunotherapy are being investigated for more efficacious, convenient and safer options with promising advances in recent years. The rationale of reducing vaccine allergenicity to increase safety while improving immunogenicity led to investigation of T-cell epitope-based peptides and recombinant allergen derivatives. Additionally, different routes of administration and adjuvants and adjunct therapies are being explored. This review discusses the current status of AIT and recent advances to improve clinical efficacy, safety and long-term immune tolerance.
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Affiliation(s)
- Alessandra Sandrini
- Department of Allergy, Immunology and Respiratory Medicine, Alfred Hospital and Monash University, Melbourne, Victoria, Australia
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16
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Jensen-Jarolim E, Einhorn L, Herrmann I, Thalhammer JG, Panakova L. Pollen Allergies in Humans and their Dogs, Cats and Horses: Differences and Similarities. Clin Transl Allergy 2015; 5:15. [PMID: 25852853 PMCID: PMC4387677 DOI: 10.1186/s13601-015-0059-6] [Citation(s) in RCA: 28] [Impact Index Per Article: 2.8] [Reference Citation Analysis] [Abstract] [Key Words] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/21/2014] [Accepted: 03/16/2015] [Indexed: 11/17/2022] Open
Abstract
Both humans and their most important domestic animals harbor IgE and a similar IgE receptor repertoire and expression pattern. The same cell types are also involved in the triggering or regulation of allergies, such as mast cells, eosinophils or T-regulatory cells. Translational clinical studies in domestic animals could therefore help cure animal allergies and at the same time gather knowledge relevant to human patients. Dogs, cats and horses may spontaneously and to different extents develop immediate type symptoms to pollen allergens. The skin, nasal and bronchial reactions, as well as chronic skin lesions due to pollen are in principle comparable to human patients. Pollen of various species most often causes allergic rhinitis in human patients, whereas in dogs it elicits predominantly eczematous lesions (canine atopic dermatitis), in horses recurrent airway obstruction or hives as well as pruritic dermatitis, and in cats bronchial asthma and so-called cutaneous reactive patterns (eosinophilic granuloma complex, head and neck pruritus, symmetric self-induced alopecia). In human allergy-specific IgE detection, skin tests or other allergen provocation tests should be completed. In contrast, in animals IgE and dermal tests are regarded as equally important and may even replace each other. However, for practical and economic reasons intradermal tests are most commonly performed in a specialized practice. As in humans, in dogs, cats and horses allergen immunotherapy leads to significant improvement of the clinical symptoms. The collected evidence suggests that canines, felines and equines, with their spontaneous allergies, are attractive model patients for translational studies.
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Affiliation(s)
- Erika Jensen-Jarolim
- Comparative Medicine, Messerli Research Institute of the University of Veterinary Medicine Vienna, Medical University Vienna and University Vienna, c/o Institute of Pathophysiology and Allergy Research, Währinger G. 18-20, Vienna, 1090 Austria
| | - Lukas Einhorn
- Comparative Medicine, Messerli Research Institute of the University of Veterinary Medicine Vienna, Medical University Vienna and University Vienna, c/o Institute of Pathophysiology and Allergy Research, Währinger G. 18-20, Vienna, 1090 Austria
| | - Ina Herrmann
- Dermatology Unit, Clinics of Small Animals and Horses, University of Veterinary Medicine, Vienna, Austria
| | - Johann G Thalhammer
- Dermatology Unit, Clinics of Small Animals and Horses, University of Veterinary Medicine, Vienna, Austria
| | - Lucia Panakova
- Dermatology Unit, Clinics of Small Animals and Horses, University of Veterinary Medicine, Vienna, Austria
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Soyka MB, van de Veen W, Holzmann D, Akdis M, Akdis CA. Scientific foundations of allergen-specific immunotherapy for allergic disease. Chest 2015; 146:1347-1357. [PMID: 25367471 DOI: 10.1378/chest.14-0049] [Citation(s) in RCA: 34] [Impact Index Per Article: 3.4] [Reference Citation Analysis] [Abstract] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/01/2022] Open
Abstract
Allergen-specific immunotherapy (AIT) was described as a therapeutic option for the treatment of allergies > 100 years ago. It is based on administration of allergen extracts and leads to the development of clinical allergen tolerance in selected patients. According to current knowledge, AIT results in the restoration of immune tolerance toward the allergen of interest. It is mainly accompanied by the induction of regulatory and suppressive subsets of T and B cells, the production of IgG4 isotype allergen-specific blocking antibodies, and decreased inflammatory responses to allergens by effector cells in inflamed tissues. Currently, AIT is mainly applied subcutaneously or sublingually and is suitable for both children and adults for pollen, pet dander, house dust mite, and venom allergies. It not only affects rhinoconjunctival symptoms but also has documented short- and long-term benefits in asthma treatment. Clinically, a fast onset of tolerance is achieved during desensitization, with a tolerable amount of side effects. The disease modification effect leads to decreased disease severity, less drug usage, prevention of future allergen sensitizations, and a long-term curative effect. Increasing safety while maintaining or even augmenting efficiency is the main goal of research for novel vaccine development and improvement of treatment schemes in AIT. This article reviews the principles of allergen-specific immune tolerance development and the effects of AIT in the clinical context.
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Affiliation(s)
- Michael B Soyka
- From the The Swiss Institute of Allergy and Asthma Research Davos, University of Zurich, Davos; Department of Otorhinolaryngology Head and Neck Surgery, University Hospital Zurich, Zurich
| | - Willem van de Veen
- From the The Swiss Institute of Allergy and Asthma Research Davos, University of Zurich, Davos
| | - David Holzmann
- Department of Otorhinolaryngology Head and Neck Surgery, University Hospital Zurich, Zurich
| | - Mübeccel Akdis
- From the The Swiss Institute of Allergy and Asthma Research Davos, University of Zurich, Davos
| | - Cezmi A Akdis
- From the The Swiss Institute of Allergy and Asthma Research Davos, University of Zurich, Davos; Department of Otorhinolaryngology Head and Neck Surgery, University Hospital Zurich, Zurich; Christine Kühne-Center for Allergy Research and Education, Davos, Switzerland.
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Verheggen BG, Westerhout KY, Schreder CH, Augustin M. Health economic comparison of SLIT allergen and SCIT allergoid immunotherapy in patients with seasonal grass-allergic rhinoconjunctivitis in Germany. Clin Transl Allergy 2015; 5:1. [PMID: 25691953 PMCID: PMC4330981 DOI: 10.1186/s13601-015-0045-z] [Citation(s) in RCA: 31] [Impact Index Per Article: 3.1] [Reference Citation Analysis] [Abstract] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/06/2014] [Accepted: 01/02/2015] [Indexed: 02/08/2023] Open
Abstract
BACKGROUND Allergoids are chemically modified allergen extracts administered to reduce allergenicity and to maintain immunogenicity. Oralair® (the 5-grass tablet) is a sublingual native grass allergen tablet for pre- and co-seasonal treatment. Based on a literature review, meta-analysis, and cost-effectiveness analysis the relative effects and costs of the 5-grass tablet versus a mix of subcutaneous allergoid compounds for grass pollen allergic rhinoconjunctivitis were assessed. METHODS A Markov model with a time horizon of nine years was used to assess the costs and effects of three-year immunotherapy treatment. Relative efficacy expressed as standardized mean differences was estimated using an indirect comparison on symptom scores extracted from available clinical trials. The Rhinitis Symptom Utility Index (RSUI) was applied as a proxy to estimate utility values for symptom scores. Drug acquisition and other medical costs were derived from published sources as well as estimates for resource use, immunotherapy persistence, and occurrence of asthma. The analysis was executed from the German payer's perspective, which includes payments of the Statutory Health Insurance (SHI) and additional payments by insurants. Comprehensive deterministic and probabilistic sensitivity analyses and different scenarios were performed to test the uncertainty concerning the incremental model outcomes. RESULTS The applied model predicted a cost-utility ratio of the 5-grass tablet versus a market mix of injectable allergoid products of € 12,593 per QALY in the base case analysis. Predicted incremental costs and QALYs were € 458 (95% confidence interval, CI: € 220; € 739) and 0.036 (95% CI: 0.002; 0.078), respectively. Compared to the allergoid mix the probability of the 5-grass tablet being the most cost-effective treatment option was predicted to be 76% at a willingness-to-pay threshold of € 20,000. The results were most sensitive to changes in efficacy estimates, duration of the pollen season, and immunotherapy persistence rates. CONCLUSIONS This analysis suggests the sublingual native 5-grass tablet to be cost-effective relative to a mix of subcutaneous allergoid compounds. The robustness of these statements has been confirmed in extensive sensitivity and scenario analyses.
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Affiliation(s)
- Bram G Verheggen
- Pharmerit International, Marten Meesweg, 107 3068AV Rotterdam, The Netherlands
| | | | | | - Matthias Augustin
- University Medical Center and Hamburg Center for Health Economics, Hamburg, Germany
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Popescu FD. Molecular biomarkers for grass pollen immunotherapy. World J Methodol 2014; 4:26-45. [PMID: 25237628 PMCID: PMC4145574 DOI: 10.5662/wjm.v4.i1.26] [Citation(s) in RCA: 25] [Impact Index Per Article: 2.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 11/23/2013] [Revised: 01/05/2014] [Accepted: 02/18/2014] [Indexed: 02/06/2023] Open
Abstract
Grass pollen allergy represents a significant cause of allergic morbidity worldwide. Component-resolved diagnosis biomarkers are increasingly used in allergy practice in order to evaluate the sensitization to grass pollen allergens, allowing the clinician to confirm genuine sensitization to the corresponding allergen plant sources and supporting an accurate prescription of allergy immunotherapy (AIT), an important approach in many regions of the world with great plant biodiversity and/or where pollen seasons may overlap. The search for candidate predictive biomarkers for grass pollen immunotherapy (tolerogenic dendritic cells and regulatory T cells biomarkers, serum blocking antibodies biomarkers, especially functional ones, immune activation and immune tolerance soluble biomarkers and apoptosis biomarkers) opens new opportunities for the early detection of clinical responders for AIT, for the follow-up of these patients and for the development of new allergy vaccines.
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Health-Related Quality of Life and Rhinitis Control Measures in Allergic Rhinitis. CURRENT TREATMENT OPTIONS IN ALLERGY 2014. [DOI: 10.1007/s40521-013-0007-4] [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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Allergen Immunotherapy: Clinical Outcomes Assessment. THE JOURNAL OF ALLERGY AND CLINICAL IMMUNOLOGY-IN PRACTICE 2014; 2:123-9; quiz 130. [DOI: 10.1016/j.jaip.2014.01.005] [Citation(s) in RCA: 14] [Impact Index Per Article: 1.3] [Reference Citation Analysis] [Track Full Text] [Subscribe] [Scholar Register] [Received: 11/18/2013] [Revised: 01/20/2014] [Accepted: 01/22/2014] [Indexed: 12/16/2022]
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