|
1
|
Alghamdi A, Alahmari M, Aljohani K, Alanazi A, Al Ibrahim B, Alshowair M, Tawfik M, Alghamdi W, Alanazi S, Alzayed F, Alghamdi AS, Bawazir A, Alhamidi H. Prevalence and clinical implications of anti-drug antibody formation and serum drug levels among patients with IBD receiving anti-TNF therapy: A cross-sectional study. Saudi J Gastroenterol 2025; 31:82-92. [PMID: 39849820 DOI: 10.4103/sjg.sjg_245_24] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/08/2024] [Accepted: 12/09/2024] [Indexed: 01/25/2025] Open
Abstract
BACKGROUND The emergence of tumor necrosis factor inhibitors (anti-TNF) has considerably changed the management of inflammatory bowel disease (IBD) in patients who do not respond to traditional therapies. This study assesses the prevalence of anti-TNF drug levels (DLs) and antibodies (ATAbs) in patients with IBD in Saudi Arabia and explores their associations with IBD type and prior anti-TNF failure. METHODS This cross-sectional study included patients aged 14-75 years diagnosed with Crohn's disease (CD) or ulcerative colitis (UC), treated with anti-TNF medications at King Fahad Medical City over January 2016 to December 2022. Data were analyzed using descriptive statistics, Mann-Whitney U test, Kruskal-Wallis test, Pearson's Chi-squared test, and multinomial logistic regression. RESULTS Among 392 patients with IBD (median age, 31 years), 75.8% were diagnosed with CD and 24.2% with UC. Anti-TNF levels were subtherapeutic in 27.0% patients, therapeutic in 21.5%, and supratherapeutic in 51.5%. ATAbs were negative in 73.1% patients, weakly positive in 9.8%, and positive in 17.1%. Subtherapeutic anti-TNF levels were significantly associated with positive ATAbs ( P < 0.001). Prior anti-TNF therapy failure was observed in 37.2% cases, with 15.3% showing immunogenicity. No significant demographic differences were noted across ATAbs groups. CONCLUSION We highlight the prevalence of subtherapeutic and supratherapeutic anti-TNF levels among patients with IBD in Saudi Arabia and their association with ATAbs. The findings underscore the importance of monitoring anti-TNF DLs and ATAbs to optimize treatment outcomes in IBD management. Future research should focus on the longitudinal impact of these factors and explore genetic predictors of treatment response.
Collapse
Affiliation(s)
- Ahmed Alghamdi
- Department of Gastroenterology and Hepatology, King Fahad Medical City, Riyadh, Saudi Arabia
- Department of Internal Medicine, College of Medicine, Dar Al Uloom University, Riyadh, Saudi Arabia
| | - Mohammed Alahmari
- Department of Gastroenterology and Hepatology, King Fahad Medical City, Riyadh, Saudi Arabia
| | - Khulood Aljohani
- Department of Gastroenterology and Hepatology, King Fahad Medical City, Riyadh, Saudi Arabia
| | - Aisha Alanazi
- Department of Gastroenterology and Hepatology, King Fahad Medical City, Riyadh, Saudi Arabia
| | - Bashaar Al Ibrahim
- Department of Gastroenterology and Hepatology, King Fahad Medical City, Riyadh, Saudi Arabia
| | - Mishal Alshowair
- Department of Gastroenterology and Hepatology, King Fahad Medical City, Riyadh, Saudi Arabia
| | - Marwa Tawfik
- Department of Gastroenterology and Hepatology, King Fahad Medical City, Riyadh, Saudi Arabia
- Internal Medicine Department, Hepatobiliary Unit, Alexandria Faculty of Medicine, Alexandria University, Alexandria, Egypt
| | - Waleed Alghamdi
- Department of Internal Medicine, King Fahad Medical City, Riyadh, Saudi Arabia
| | - Salman Alanazi
- Department of Internal Medicine, King Fahad Medical City, Riyadh, Saudi Arabia
| | - Faisal Alzayed
- Department of Internal Medicine, King Fahad Medical City, Riyadh, Saudi Arabia
| | - Abdullah S Alghamdi
- Department of Gastroenterology and Hepatology, King Fahad Medical City, Riyadh, Saudi Arabia
| | - Abdullah Bawazir
- Department of Internal Medicine, King Fahad Medical City, Riyadh, Saudi Arabia
| | - Hussam Alhamidi
- Department of Gastroenterology and Hepatology, King Fahad Medical City, Riyadh, Saudi Arabia
| |
Collapse
|
|
2
|
Riveiro-Barciela M, Carballal S, Díaz-González Á, Mañosa M, Gallego-Plazas J, Cubiella J, Jiménez-Fonseca P, Varela M, Menchén L, Sangro B, Fernández-Montes A, Mesonero F, Rodríguez-Gandía MÁ, Rivera F, Londoño MC. Management of liver and gastrointestinal toxicity induced by immune checkpoint inhibitors: Position statement of the AEEH-AEG-SEPD-SEOM-GETECCU. GASTROENTEROLOGIA Y HEPATOLOGIA 2024; 47:401-432. [PMID: 38228461 DOI: 10.1016/j.gastrohep.2023.10.009] [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: 06/12/2023] [Revised: 09/28/2023] [Accepted: 10/19/2023] [Indexed: 01/18/2024]
Abstract
The development of the immune checkpoint inhibitors (ICI) is one of the most remarkable achievements in cancer therapy in recent years. However, their exponential use has led to an increase in immune-related adverse events (irAEs). Gastrointestinal and liver events encompass hepatitis, colitis and upper digestive tract symptoms accounting for the most common irAEs, with incidence rates varying from 2% to 40%, the latter in patients undergoing combined ICIs therapy. Based on the current scientific evidence derived from both randomized clinical trials and real-world studies, this statement document provides recommendations on the diagnosis, treatment and prognosis of the gastrointestinal and hepatic ICI-induced adverse events.
Collapse
Affiliation(s)
- Mar Riveiro-Barciela
- Liver Unit, Internal Medicine Department, Hospital Universitari Vall d'Hebron, Vall d'Hebron Barcelona Hospital Campus, Barcelona, Spain; Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Instituto de Salud Carlos III, Madrid, Spain; Universitat Autònoma de Barcelona (UAB), Department of Medicine, Spain.
| | - Sabela Carballal
- Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Instituto de Salud Carlos III, Madrid, Spain; Gastroenterology Department, Hospital Clinic de Barcelona, Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Spain; Universitat de Barcelona, Spain
| | - Álvaro Díaz-González
- Gastroenterology Department, Grupo de Investigación Clínica y Traslacional en Enfermedades Digestivas, Instituto de Investigación Valdecilla (IDIVAL), Hospital Universitario Marqués de Valdecilla, Santander, Spain
| | - Míriam Mañosa
- Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Instituto de Salud Carlos III, Madrid, Spain; Gastroenterology Department, Hospital Universitari Germans Trias i Pujol, Badalona, Spain
| | | | - Joaquín Cubiella
- Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Instituto de Salud Carlos III, Madrid, Spain; Gastroenterology Department, Hospital Universitario de Ourense, Grupo de Investigación en Oncología Digestiva-Ourense, Spain
| | - Paula Jiménez-Fonseca
- Medical Oncology Department, Hospital Universitario Central de Asturias, ISPA, Oviedo, Spain
| | - María Varela
- Gastroenterology Department, Hospital Universitario Central de Asturias, IUOPA, ISPA, FINBA, University of Oviedo, Oviedo, Spain
| | - Luis Menchén
- Servicio de Aparato Digestivo - CEIMI, Instituto de Investigación Sanitaria Gregorio, Marañón, Spain; Departamento de Medicina, Universidad Complutense, Madrid, Spain
| | - Bruno Sangro
- Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Instituto de Salud Carlos III, Madrid, Spain; Liver Unit, Cancer Center Clinica Universidad de Navarra, Pamplona-Madrid, Spain
| | - Ana Fernández-Montes
- Medical Oncology Department, Complexo Hospitalario Universitario de Ourense, Ourense, Spain
| | - Francisco Mesonero
- Gastroenterology and Hepatology Department, Hospital Universitario Ramón y Cajal, Madrid, Spain; Universidad de Alcalá de Henares, Spain
| | - Miguel Ángel Rodríguez-Gandía
- Gastroenterology and Hepatology Department, Hospital Universitario Ramón y Cajal, Madrid, Spain; Instituto Ramón y Cajal de Investigación Sanitaria (IRyCIS), Madrid, Spain
| | - Fernando Rivera
- Medical Oncology Department, Hospital Universitario Marqués de Valdecilla, IDIVAL, Santander, Spain
| | - María-Carlota Londoño
- Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Instituto de Salud Carlos III, Madrid, Spain; Universitat de Barcelona, Spain; Liver Unit, Hospital Clínic Barcelona, Fundació de Recerca Clínic Barcelona-Institut d'Investigacions Biomèdiques August Pi i Sunyer, European Reference Network on Hepatological Diseases (ERN RARE-LIVER), Spain
| |
Collapse
|
|
3
|
Riveiro-Barciela M, Carballal S, Díaz-González Á, Mañosa M, Gallgo-Plazas J, Cubiella J, Jiménez-Fonseca P, Varela M, Menchén L, Sangro B, Fernández-Montes A, Mesonero F, Rodríguez-Gandía MÁ, Rivera F, Londoño MC. Management of liver and gastrointestinal toxicity induced by immune checkpoint inhibitors: Position statement of the AEEH-AEG-SEPD-SEOM-GETECCU. REVISTA ESPANOLA DE ENFERMEDADES DIGESTIVAS 2024; 116:83-113. [PMID: 38226597 DOI: 10.17235/reed.2024.10250/2024] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 01/17/2024]
Abstract
The development of the immune checkpoint inhibitors (ICI) is one of the most remarkable achievements in cancer therapy in recent years. However, their exponential use has led to an increase in immune-related adverse events (irAEs). Gastrointestinal and liver events encompass hepatitis, colitis and upper digestive tract symptoms accounting for the most common irAEs, with incidence rates varying from 2 % to 40 %, the latter in patients undergoing combined ICIs therapy. Based on the current scientific evidence derived from both randomized clinical trials and real-world studies, this statement document provides recommendations on the diagnosis, treatment and prognosis of the gastrointestinal and hepatic ICI-induced adverse events.
Collapse
Affiliation(s)
| | | | | | - Miriam Mañosa
- Gastroenterology, Hospital Universitari Germans Trias i Pujol
| | | | | | | | - María Varela
- Gastroenterology, Hospital Universitario Central de Asturias
| | - Luis Menchén
- Digestive Diseases, Instituto de Investigación Sanitaria Gregorio Marañón
| | | | | | | | | | - Fernando Rivera
- Hospital Universitario Marqués de Valdecilla, Medical Oncology
| | | |
Collapse
|
|
4
|
Davis González MR, Ballester MP, Romero-González E, Sánchez-Pardo AM, Marti-Aguado D, Tosca J, Suria C, Antón Ausejo R, Pascual Moreno I, Planelles Silvestre MD, Mínguez Pérez M, Bosca-Watts MM. Biological treatment interruption in inflammatory bowel disease: Motivation and predictive factors. GASTROENTEROLOGIA Y HEPATOLOGIA 2023; 46:671-681. [PMID: 36375696 DOI: 10.1016/j.gastrohep.2022.10.021] [Citation(s) in RCA: 3] [Impact Index Per Article: 1.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Subscribe] [Scholar Register] [Received: 08/04/2022] [Revised: 10/14/2022] [Accepted: 10/18/2022] [Indexed: 11/13/2022]
Abstract
BACKGROUND Loss-of-response and adverse events (AE) to biologics have been linked to HLA-DQA1*05 allele. However, the clinical factors or biologic used may influence treatment duration. Our objective was to evaluate the influence of clinical and therapeutic factors, along with HLA, in biological treatment discontinuation. METHODS A retrospective study of consecutive IBD patients treated with biologics between 2007 and 2011 was performed. Main outcome was treatment discontinuation due to primary non-response (PNR), secondary loss of response (SLR) or AE. HLA-DQA1 genotyping was done in all patients. Regression analyses were used to assess risk factors of treatment discontinuation. RESULTS One hundred fifty patients (61% male) with 312 biologic treatments were included. 147 (47%) were discontinued with a cumulative probability of 30%, 41% and 56% at 1, 2 and 5 years. The use of infliximab (p=0.006) and articular manifestations (p<0.05) were associated with treatment discontinuation. Considering cause of withdrawal, Ulcerative Colitis (UC) had a higher proportion of PNR (HR=4.99; 95% CI=1.71-14.63; p=0.003), SLR was higher if biologics had been indicated due to disease flare (HR=2.32; 95% CI=1.05-5.09; p=0.037) while AE were greater with infliximab (HR=2.46; 95% CI=1.48-4.08; p<0.001) or spondylitis (HR=2.46; 95% CI=1.78-6.89; p<0.001). According to the biological drug, HLA-DQA1*05 with adalimumab showed more SLR in cases with Crohn's disease (HR=3.49; 95% CI=1.39-8,78; p=0.008) or without concomitant immunomodulator (HR=2.8; 95% CI=1.1-6.93; p=0.026). CONCLUSIONS HLA-DQ A1*05 was relevant in SLR of IBD patients treated with adalimumab without immunosupression. In patients treated with other biologics, clinical factors were more important for treatment interruption, mainly extensive UC or extraintestinal manifestations and having indicated the biologic for flare.
Collapse
Affiliation(s)
- María Rocío Davis González
- IBD Unit, Digestive Disease Medicine, University of Valencia, University Clinic Hospital of Valencia, Spain
| | - María Pilar Ballester
- IBD Unit, Digestive Disease Medicine, University of Valencia, University Clinic Hospital of Valencia, Spain; Instituto de Investigación Sanitaria INCLIVA, Spain.
| | - Eva Romero-González
- IBD Unit, Digestive Disease Medicine, University of Valencia, University Clinic Hospital of Valencia, Spain
| | - Ana María Sánchez-Pardo
- IBD Unit, Digestive Disease Medicine, University of Valencia, University Clinic Hospital of Valencia, Spain
| | - David Marti-Aguado
- IBD Unit, Digestive Disease Medicine, University of Valencia, University Clinic Hospital of Valencia, Spain
| | - Joan Tosca
- IBD Unit, Digestive Disease Medicine, University of Valencia, University Clinic Hospital of Valencia, Spain
| | - Carles Suria
- IBD Unit, Digestive Disease Medicine, University of Valencia, University Clinic Hospital of Valencia, Spain
| | - Rosario Antón Ausejo
- IBD Unit, Digestive Disease Medicine, University of Valencia, University Clinic Hospital of Valencia, Spain
| | - Isabel Pascual Moreno
- IBD Unit, Digestive Disease Medicine, University of Valencia, University Clinic Hospital of Valencia, Spain
| | | | - Miguel Mínguez Pérez
- IBD Unit, Digestive Disease Medicine, University of Valencia, University Clinic Hospital of Valencia, Spain
| | - Marta Maia Bosca-Watts
- IBD Unit, Digestive Disease Medicine, University of Valencia, University Clinic Hospital of Valencia, Spain
| |
Collapse
|
|
5
|
Sicilia B, García-López S, González-Lama Y, Zabana Y, Hinojosa J, Gomollón F. GETECCU 2020 guidelines for the treatment of ulcerative colitis. Developed using the GRADE approach. GASTROENTEROLOGIA Y HEPATOLOGIA 2021; 43 Suppl 1:1-57. [PMID: 32807301 DOI: 10.1016/j.gastrohep.2020.07.001] [Citation(s) in RCA: 23] [Impact Index Per Article: 5.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Subscribe] [Scholar Register] [Received: 07/15/2020] [Accepted: 07/22/2020] [Indexed: 12/12/2022]
Abstract
INTRODUCTION Since the first edition of the Guidelines was published in 2013, much information has been generated around the treatment of ulcerative colitis, and new drugs and action protocols have been introduced. Clinical practice has changed substantially, warranting new approaches and a comprehensive review and update of the evidence. MATERIAL AND METHODS Once again, we used the GRADE approach, supported by an electronic tool (https://gradepro.org). The clinical scenarios are the same as in the previous version (induction and maintenance in severe and mild-moderate flare-ups), as are the variables and their evaluation. However, in the updated guidelines, three questions have been deleted, 14 added and 30 maintained, making a total of 44 clinical questions. After an exhaustive review of the evidence, the recommendations are now updated. RESULTS Of the 44 questions analysed, no recommendation could be established in two due to the very low quality of the evidence, while in the other 42, based on different degrees of quality of evidence, recommendations were made according to the GRADE system. In 25 of these questions the final recommendation is strongly in favour, in six strongly against, in seven weakly in favour and in four weakly against. According to the scenarios and recommendations, six algorithms are proposed as a simple guide for practical decision-making. CONCLUSIONS The aim of this update of the 2013 guidelines is to provide answers, based on the GRADE approach, to the different questions we ask ourselves daily when deciding the most appropriate treatment for our patients with ulcerative colitis in the different clinical scenarios.
Collapse
Affiliation(s)
- Beatriz Sicilia
- Unidad de Enfermedad Inflamatoria Intestinal, Servicio de Aparato Digestivo, Hospital Universitario de Burgos, España
| | - Santiago García-López
- Unidad de Enfermedad Inflamatoria Intestinal, Servicio de Aparato Digestivo, Hospital Universitario Miguel Servet, Instituto de Investigaciones Sanitarias de Aragón, Zaragoza, España.
| | - Yago González-Lama
- Unidad de Enfermedad Inflamatoria Intestinal, Servicio de Aparato Digestivo, Hospital Universitario Puerta de Hierro, Madrid, España
| | - Yamile Zabana
- Unidad de Enfermedad Inflamatoria Intestinal, Servicio de Aparato Digestivo Hospital Universitario Mútua Terrassa Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd)
| | - Joaquín Hinojosa
- Unidad de Enfermedad Inflamatoria Intestinal, Servicio de Aparato Digestivo, Hospital de Manises, Valencia, España
| | - Fernando Gomollón
- Unidad de Enfermedad Inflamatoria Intestinal, Servicio de Aparato Digestivo, Instituto de Investigaciones Sanitarias de Aragón, Hospital Clínico Universitario Lozano Blesa, Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), Zaragoza, España
| | | | | |
Collapse
|
|
6
|
González-Lama Y, Sanz J, Bastida G, Campos J, Ferreiro R, Joven B, Gutiérrez A, Juanola X, Sicilia B, Veroz R, P Gisbert J, Chaparro M, Domènech E, Esteve M, Gomollón F. Recommendations by the Spanish Working Group on Crohn's Disease and Ulcerative Colitis (GETECCU) on the treatment of patients with inflammatory bowel disease associated with spondyloarthritis. GASTROENTEROLOGIA Y HEPATOLOGIA 2020; 43:273-283. [PMID: 32247533 DOI: 10.1016/j.gastrohep.2020.01.005] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Subscribe] [Scholar Register] [Received: 12/15/2019] [Accepted: 01/28/2020] [Indexed: 10/24/2022]
Abstract
Extraintestinal manifestations, in general, and in particular arthropathies, are a common problem in patients with inflammatory bowel disease. In fact, the relationship between those 2entities is close and there are increasingly more data which suggest that the bowel plays a significant role in the aetiopathogenesis of spondyloarthritis. The association of inflammatory bowel disease with any kind of spondyloarthritis represents a challenging clinical scenario. It is therefore necessary that both gastroenterologists and rheumatologists work together and establish a fluent communication that enables the patient to receive the most appropriate treatment for each specific situation. The aim of this review is to make some recommendations about the treatment of patients with inflammatory bowel disease and associated spondyloarthritis, in each different clinical scenario.
Collapse
Affiliation(s)
- Yago González-Lama
- Unidad de Enfermedad Inflamatoria Intestinal, Servicio de Gastroenterología y Hepatología, Hospital Universitario Puerta de Hierro, Majadahonda, Madrid, España.
| | - Jesús Sanz
- Servicio de Reumatología, Hospital Universitario Puerta de Hierro, Majadahonda, Madrid, España
| | - Guillermo Bastida
- Unidad de Enfermedad Inflamatoria Intestinal, Servicio de Aparato Digestivo, Hospital Universitario La Fe, Valencia, España
| | - José Campos
- Servicio de Reumatología, Hospital Universitario Puerta de Hierro, Majadahonda, Madrid, España
| | - Rocío Ferreiro
- Unidad de Enfermedad Inflamatoria Intestinal, Servicio de Aparato Digestivo, Complejo Hospital Universitario de Santiago, Santiago de Compostela, La Coruña, España
| | - Beatriz Joven
- Servicio de Reumatología, Hospital Universitario Doce de Octubre, Madrid, España
| | - Ana Gutiérrez
- Servicio de Medicina Digestiva, Hospital General Universitario de Alicante, Alicante, Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), Instituto de Salud Carlos III, Alicante, España
| | - Xavier Juanola
- Servicio de Reumatología, Hospital Universitario de Bellvitge, IDIBELL, L'Hospitalet del Llobregat, Barcelona, España
| | - Beatriz Sicilia
- Unidad de Enfermedad Inflamatoria Intestinal, Servicio de Aparato Digestivo, Hospital Universitario de Burgos, Burgos, España
| | - Raúl Veroz
- Servicio de Reumatología, Hospital de Mérida, Mérida, Badajoz, España
| | - Javier P Gisbert
- Servicio de Aparato Digestivo, Hospital Universitario de La Princesa, Instituto de Investigación Sanitaria Princesa (IIS-IP) y CIBEREHD, Madrid, España
| | - María Chaparro
- Servicio de Aparato Digestivo, Hospital Universitario de La Princesa, Instituto de Investigación Sanitaria Princesa (IIS-IP) y CIBEREHD, Madrid, España
| | - Eugeni Domènech
- Servicio de Aparato Digestivo, Hospital Universitari Germans Trias i Pujol, CIBEREHD, Badalona, Barcelona, España
| | - María Esteve
- Servicio de Aparato Digestivo, Hospital Universitari Mutua Terrassa, CIBEREHD, Terrassa, Barcelona, España
| | - Fernando Gomollón
- Unidad de Enfermedad Inflamatoria Intestinal, Servicio de Aparato Digestivo, Hospital Clínico Universitario Lozano Blesa, IIS Aragón. CIBEREHD, Zaragoza, España
| |
Collapse
|
|
7
|
Clinical assessment of risk factors for infection in inflammatory bowel disease patients. Int J Colorectal Dis 2020; 35:491-500. [PMID: 31915983 DOI: 10.1007/s00384-019-03501-0] [Citation(s) in RCA: 7] [Impact Index Per Article: 1.4] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Accepted: 12/26/2019] [Indexed: 02/04/2023]
Abstract
PURPOSE Recognizing patients with inflammatory bowel disease who are prone to infection would enable the adjustment of the type and intensity of immunosuppressive treatment. The aim of this study was to identify a clinical profile of risk for infections in IBD patients, based on the interaction of immunosuppressive treatment with factors inherent to the patient. METHODS A case-control study was performed among patients older than 18 years. Patients with any significant infection (any kind of severe or recurrent infection according to standard clinical criteria or a critical enough infection according to the patient) were defined as cases. Both cases and controls were randomly selected in a 1:3 ratio. All the period from diagnosis to the end of recruitment (June 2016) was analyzed. Risk factors for infection were identified by logistic regression analysis; the strength of association was reported by odds ratio (OR) with 95% confidence interval (95%CI). RESULTS A total of 112 cases and 270 controls were included. The independent risk factors for significant infection are the number of immunosuppressants (one drug: OR 1.28, 95% CI 0.53-3.11, two drugs: OR 2.37, 95% CI 1.01-5,56, and three drugs: OR 5.84, 95% CI 1.57-21.72), body mass index (OR 1.08; 95 %CI 1,01-1,16), the degree of comorbidity (OR 1.52; 95% CI 1.04-2.21), and the intensity of inflammatory activity (OR 1.43; 95% CI 1.19-1.71). CONCLUSIONS Regardless of immunosuppression, several patient factors such as comorbidity, body mass index, or the inflammatory activity of the disease determine the individual risk of infectious complications and should be considered for an adequate risk assessment.
Collapse
|
|
8
|
Launch and preliminary analysis of Hospital de La Princesa's inter-specialists biological therapies unit. ACTA ACUST UNITED AC 2019; 15:63-68. [PMID: 30691949 DOI: 10.1016/j.reuma.2018.11.008] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/20/2018] [Accepted: 11/24/2018] [Indexed: 11/23/2022]
Abstract
We herein describe an inter-specialists unit for the monitoring and management of biological therapies and analyze the utilization of biological agents across specialties and diseases. Protocols and therapeutic objectives, as well as outcomes and protocol deviations, are shared and discussed periodically between specialists. All patients treated at one centre with any biological treatment from January 2000 by rheumatology, gastroenterology, dermatology, or neurology, regardless diagnosis, are identified by Clinical Pharmacy and included in an ongoing database that detects use and outcome. The drugs, survival, and reasons for discontinuation differ significantly across specialties. This approach has helped us recognizing the challenges and size of the problem of sharing expensive medications across specialties, and has served as a starting point to contribute to the better use of these compounds.
Collapse
|
|
9
|
Cabriada JL, Ruiz-Zorrilla R, Barrio J, Atienza R, Huerta A, Rodríguez-Lago I, Bernal A, Herrero C. Screening for latent tuberculosis infection in patients with inflammatory bowel disease: Can interferon-gamma release assays replace the tuberculin skin test? TURKISH JOURNAL OF GASTROENTEROLOGY 2018; 29:292-298. [PMID: 29755013 DOI: 10.5152/tjg.2018.17162] [Citation(s) in RCA: 5] [Impact Index Per Article: 0.7] [Reference Citation Analysis] [Abstract] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 12/13/2022]
Abstract
BACKGROUND/AIMS Screening for latent tuberculosis infection is mandatory before starting anti-tumor necrosis factor therapy. New assays based on interferon-γ (IFN-γ) release have recently become available and may be more accurate. The aim of this study was to compare QuantiFERON-TB and tuberculin skin test in screening for latent infection in patients with inflammatory bowel disease. MATERIALS AND METHODS We prospectively screened 138 patients with inflammatory bowel disease for latent tuberculosis infection with chest X-ray, tuberculin skin test, and a third-generation QuantiFERON-TB test. The association of the results in both tests with immunosuppression or inflammatory activity was determined by logistic regression. RESULTS The tuberculin skin test and QuantiFERON-TB were positive in 21.7% and 24.6% of the patients, respectively. Overall, 71% patients were receiving immunosuppressants. Concordance between the two tests was moderate (κ=0.59; 95% confidence interval (CI), 0.43-0.75) and was higher in immunosuppressant-naïve patients (κ=0.75; 95% CI, 0.52-0.97) than in immunosuppressed patients (κ=0.51; 95% CI, 0.30-0.72). In both the tests, disease activity and receiving immunosuppression were not associated with the test results. Nevertheless, QuantiFERON-TB was negatively influenced with two or more immunosuppressive drugs. CONCLUSION Concordance between the two tests was moderate, and it appears lower with immunosuppression. QuantiFERON-TB alone may be appropriate in immunosuppressant-naïve patients. Both tests should be considered in immunosuppressed patients.
Collapse
Affiliation(s)
- José Luis Cabriada
- Department of Gastroenterology Hospital de Galdakao-Usansolo, Vizcaya, Spain
| | | | - Jesús Barrio
- Department of Gastroenterology Hospital Río Hortega, Valladolid, Spain
| | - Ramón Atienza
- Department of Gastroenterology Hospital Río Hortega, Valladolid, Spain
| | - Alain Huerta
- Department of Gastroenterology Hospital de Galdakao-Usansolo, Vizcaya, Spain
| | - Iago Rodríguez-Lago
- Department of Gastroenterology Hospital de Galdakao-Usansolo, Vizcaya, Spain
| | - Antonio Bernal
- Department of Gastroenterology Hospital de Galdakao-Usansolo, Vizcaya, Spain
| | - César Herrero
- Department of Gastroenterology Hospital Río Hortega, Valladolid, Spain
| |
Collapse
|
|
10
|
Castro-Poceiro J, Fernández-Clotet A, Panés J. Mesenchymal stromal cells in the treatment of perianal fistulas in Crohn's disease. Immunotherapy 2018; 10:1203-1217. [DOI: 10.2217/imt-2018-0099] [Citation(s) in RCA: 9] [Impact Index Per Article: 1.3] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/17/2022] Open
Abstract
Significant unmet needs remain in patients with Crohn's disease and perianal fistulas. Mesenchymal stromal cells have potent immunomodulatory actions. The Phase II studies reported efficacy of local injection of mesenchymal stromal cells to achieve closure of fistulas. A Phase III trial demonstrated that in patients with Crohn's disease and refractory complex perianal fistulas, a single injection of 120 × 106 cells was superior to local injection of placebo associated with the same surgical procedure, in obtaining closure of the fistula tracts together with absence of abscesses >2 cm, 24 weeks after the injection, a stringent combined primary end point. The benefit over placebo was sustained 52 weeks after the single injection. The therapy is safe with adverse events limited to local pain.
Collapse
Affiliation(s)
- Jesús Castro-Poceiro
- Department of Gastroenterology, Hospital Clínic de Barcelona, IDIBAPS, CIBERehd, Barcelona, Spain
| | - Agnès Fernández-Clotet
- Department of Gastroenterology, Hospital Clínic de Barcelona, IDIBAPS, CIBERehd, Barcelona, Spain
| | - Julián Panés
- Department of Gastroenterology, Hospital Clínic de Barcelona, IDIBAPS, CIBERehd, Barcelona, Spain
| |
Collapse
|
|
11
|
Huguet JM, Iborra M, Bosca-Watts MM, Maroto N, Gil R, Cortes X, Hervás D, Paredes JM. Inflammatory bowel disease in patients over the age of 70 y. Does the disease duration influence its behavior? Scand J Gastroenterol 2018; 53:1079-1084. [PMID: 30189153 DOI: 10.1080/00365521.2018.1501603] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.6] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 02/04/2023]
Abstract
INTRODUCTION The fastest growing segment of our population is that of people above 70 years of age. Elderly patients with IBD exhibit several specific problems. Our objective was to evaluate the clinical course, the side effects of the treatments and the need for surgery of elderly patients, regardless of the age of onset. MATERIALS AND METHODS This was a cross-sectional study wherein retrospective data were collected from multiple centers from seven hospitals within the Valencia metropolitan area. Data were collected on patients older than 70 y with inflammatory bowel disease. RESULTS We identified a total of 331 patients older than 70 years of age (5.3% of patients monitored at our centers). The mean age at the time of the study was 77.34 y (±5.39). Mesalamine were the most frequently used medications. Corticosteroids were used in 66% of the patients. However, the use of corticosteroids and biologics was less probable in older patients (OR 0.96, p = .06). The longer the disease progressed, the more immunosuppressive medications were used (OR 1.3, p = .052). Neoplasms appeared in 41 patients (13%). Of the 36 patients with tumors that appeared after the onset of the disease, 20 patients had not been treated with immunomodulators or biologics. CONCLUSIONS Mesalamine was the most frequently used medication. There is no increased risk of tumors regarding the medications used. The use of immunosuppressive medications is more prevalent with longer disease progression times, although with a high rate of adverse events.
Collapse
Affiliation(s)
- Jose M Huguet
- a Digestive Disease Department , General University Hospital of Valencia , Valencia , Spain
| | - Marisa Iborra
- b Gastroenterology Department and CIBEREHD , Hospital Universitari i Politecnic La Fe , Valencia , Spain
| | - Marta Maia Bosca-Watts
- c Inflammatory Bowel Disease Unit, Digestive Disease Department , University of Valencia, University Clinic Hospital of Valencia , Valencia , Spain
| | - Nuria Maroto
- d Inflammatory Bowel Disease Unit, Digestive Disease Department , Hospital of Manises , Manises , Spain
| | - Rafael Gil
- e Digestive Disease Department , Arnau of Vilanova of Valencia Hospital , Spain Valencia
| | - Xavier Cortes
- f Digestive Disease Department , Hospital of Sagunto , Valencia , Spain
| | - David Hervás
- g Statistics Unit, Hospital Universitari i Politècnic la Fe , Valencia , Spain
| | - Jose M Paredes
- h Digestive Disease Department , Peset University Hospital of Valencia , Valencia , Spain
| |
Collapse
|
|
12
|
Gisbert JP, Chaparro M. Ustekinumab to treat Crohn's disease. GASTROENTEROLOGIA Y HEPATOLOGIA 2017; 40:688-698. [PMID: 29042094 DOI: 10.1016/j.gastrohep.2017.08.006] [Citation(s) in RCA: 10] [Impact Index Per Article: 1.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Subscribe] [Scholar Register] [Received: 06/21/2017] [Accepted: 08/21/2017] [Indexed: 12/14/2022]
Abstract
Ustekinumab is a monoclonal antibody directed against the p40 subunit, which is part of interleukins IL-12 and IL-23. The efficacy of ustekinumab versus placebo in terms of clinical response and remission of induction has been shown in phase3 clinical trials. When used as subcutaneous maintenance therapy, the therapeutic benefit of ustekinumab over placebo has been confirmed in both clinical response and remission in patients who have responded clinically to induction therapy. In addition, ustekinumab has demonstrated an improvement in mucosal healing parameters. The safety profile of the drug has been good, with low infection rates (without reactivation of tuberculosis) and absence of tumour reporting. The development of drug immunogenicity appears to be rare. In summary, ustekinumab is a promising treatment option in patients with Crohn's disease, as an alternative to anti-TNFα drugs.
Collapse
Affiliation(s)
- Javier P Gisbert
- Servicio de Aparato Digestivo, Hospital Universitario de La Princesa, Instituto de Investigación Sanitaria Princesa (IIS-IP), Universidad Autónoma de Madrid y Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), Madrid, España.
| | - María Chaparro
- Servicio de Aparato Digestivo, Hospital Universitario de La Princesa, Instituto de Investigación Sanitaria Princesa (IIS-IP), Universidad Autónoma de Madrid y Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), Madrid, España
| |
Collapse
|
|
13
|
Péntek M, Lakatos PL, Oorsprong T, Gulácsi L, Pavlova M, Groot W, Rencz F, Brodszky V, Baji P, Crohn’s Disease Research Group. Access to biologicals in Crohn’s disease in ten European countries. World J Gastroenterol 2017; 23:6294-6305. [PMID: 28974896 PMCID: PMC5603496 DOI: 10.3748/wjg.v23.i34.6294] [Citation(s) in RCA: 34] [Impact Index Per Article: 4.3] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/18/2017] [Revised: 07/05/2017] [Accepted: 08/08/2017] [Indexed: 02/06/2023] Open
Abstract
AIM To analyze access (availability, affordability and acceptability) to biologicals for Crohn’s disease (CD) in ten European countries and to explore the associations between these dimensions, the uptake of biologicals and economic development.
METHODS A questionnaire-based survey combined with desk research was carried out in May 2016. Gastroenterologists from the Czech Republic, France, Germany, Hungary, Latvia, Poland, Romania, Slovakia, Spain and Sweden were invited to participate and provide data on the availability of biologicals/biosimilars, reimbursement criteria, clinical practice and prices, and use of biologicals. An availability score was developed to evaluate the restrictiveness of eligibility and administrative criteria applied in the countries. Affordability was defined as the annual cost of treatment as a share of gross domestic product (GDP) per capita. Correlations with the uptake of biologicals, dimensions of access and GDP per capita were calculated.
RESULTS At the time of the survey, infliximab and adalimumab were reimbursed in all ten countries, and vedolizumab was reimbursed in five countries (France, Germany, Latvia, Slovakia, Sweden). Reimbursement criteria were the least strict in Sweden and Germany, and the strictest in Hungary, Poland and Slovakia. Between countries, the annual cost of different biological treatments differed 1.6-3.3-fold. Treatments were the most affordable in Sweden (13%-37% of the GDP per capita) and the least affordable in the Central and Eastern European countries, especially in Hungary (87%-124%) and Romania (141%-277%). Biosimilars made treatments more affordable by driving down the annual costs. The number of patients with CD on biologicals per 100000 population was strongly correlated with GDP per capita (0.91), although substantial differences were found in the uptake among countries with similar economic development. Correlation between the number of patients with CD on biologicals per 100000 population and the availability and affordability was also strong (-0.75, -0.69 respectively).
CONCLUSION Substantial inequalities in access to biologicals were largely associated with GDP. To explain differences in access among countries with similar development needs further research on acceptance.
Collapse
Affiliation(s)
- Márta Péntek
- Department of Health Economics, Corvinus University of Budapest, H-1093 Budapest, Hungary
| | - Peter L Lakatos
- McGill University, MUHC, Montreal General Hospital, H3G 1A4 Montreal, Canada
- 1st Department of Internal Medicine, Semmelweis University, H-1083 Budapest, Hungary
| | - Talitha Oorsprong
- Department of Health Services Research, CAPHRI, Maastricht University Medical Centre, Faculty of Health, Medicine and Life Sciences, Maastricht University, 6229 GT Maastricht, The Netherlands
| | - László Gulácsi
- Department of Health Economics, Corvinus University of Budapest, H-1093 Budapest, Hungary
| | - Milena Pavlova
- Department of Health Services Research, CAPHRI, Maastricht University Medical Centre, Faculty of Health, Medicine and Life Sciences, Maastricht University, 6229 GT Maastricht, The Netherlands
| | - Wim Groot
- Department of Health Services Research, CAPHRI, Maastricht University Medical Centre, Faculty of Health, Medicine and Life Sciences, Maastricht University, 6229 GT Maastricht, The Netherlands
- Top Institute Evidence Based Education Research (TIER), Teachers Academy, Maastricht University, 6211 KH Maastricht, The Netherlands
| | - Fanni Rencz
- Department of Health Economics, Corvinus University of Budapest, H-1093 Budapest, Hungary
| | - Valentin Brodszky
- Department of Health Economics, Corvinus University of Budapest, H-1093 Budapest, Hungary
| | - Petra Baji
- Department of Health Economics, Corvinus University of Budapest, H-1093 Budapest, Hungary
| | | |
Collapse
|
|
14
|
Barreiro-de Acosta M, Gisbert JP. Editorial: relative efficacy of infliximab and adalimumab in Crohn's disease in an Australian and New Zealand cohort. Aliment Pharmacol Ther 2017; 45:855-856. [PMID: 28211628 DOI: 10.1111/apt.13929] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/11/2022]
Affiliation(s)
- M Barreiro-de Acosta
- Department of Gastroenterology, Hospital Clínico Universitario de Santiago de Compostela, Santiago, Spain
| | - J P Gisbert
- Department of Gastroenterology, Hospital Universitario de La Princesa, Instituto de Investigación Sanitaria Princesa (IIS-IP) and Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), Madrid, Spain
| |
Collapse
|
|
15
|
Evolution After Anti-TNF Discontinuation in Patients With Inflammatory Bowel Disease: A Multicenter Long-Term Follow-Up Study. Am J Gastroenterol 2017; 112:120-131. [PMID: 27958281 DOI: 10.1038/ajg.2016.569] [Citation(s) in RCA: 88] [Impact Index Per Article: 11.0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 04/09/2016] [Accepted: 10/04/2016] [Indexed: 12/11/2022]
Abstract
OBJECTIVES The aims of this study were to assess the risk of relapse after discontinuation of anti-tumor necrosis factor (anti-TNF) drugs in patients with inflammatory bowel disease (IBD), to identify the factors associated with relapse, and to evaluate the overcome after retreatment with the same anti-TNF in those who relapsed. METHODS This was a retrospective, observational, multicenter study. IBD patients who had been treated with anti-TNFs and in whom these drugs were discontinued after clinical remission was achieved were included. RESULTS A total of 1,055 patients were included. The incidence rate of relapse was 19% and 17% per patient-year in Crohn's disease and ulcerative colitis patients, respectively. In both Crohn's disease and ulcerative colitis patients in deep remission, the incidence rate of relapse was 19% per patient-year. The treatment with adalimumab vs. infliximab (hazard ratio (HR)=1.29; 95% confidence interval (CI)=1.01-1.66), elective discontinuation of anti-TNFs (HR=1.90; 95% CI=1.07-3.37) or discontinuation because of adverse events (HR=2.33; 95% CI=1.27-2.02) vs. a top-down strategy, colonic localization (HR=1.51; 95% CI=1.13-2.02) vs. ileal, and stricturing behavior (HR=1.5; 95% CI=1.09-2.05) vs. inflammatory were associated with a higher risk of relapse in Crohn's disease patients, whereas treatment with immunomodulators after discontinuation (HR=0.67; 95% CI=0.51-0.87) and age (HR=0.98; 95% CI=0.97-0.99) were protective factors. None of the factors were predictive in ulcerative colitis patients. Retreatment of relapse with the same anti-TNF was effective (80% responded) and safe. CONCLUSIONS The incidence rate of inflammatory bowel disease relapse after anti-TNF discontinuation is relevant. Some predictive factors of relapse after anti-TNF withdrawal have been identified. Retreatment with the same anti-TNF drug was effective and safe.
Collapse
|
|
16
|
Agudo B, Díaz G, González-Lama Y. Adalimumab-Receiving Ulcerative Colitis Patient Suffered Latent Tuberculosis Reactivation Despite Correct Chemoprophylaxis and was Successfully Treated while on Anti-Tumour Necrosis Factor Therapy. J Crohns Colitis 2016; 10:1453-1454. [PMID: 27215554 DOI: 10.1093/ecco-jcc/jjw110] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/13/2016] [Accepted: 05/16/2016] [Indexed: 02/08/2023]
Affiliation(s)
- Belén Agudo
- Department of Gastroenterology and Hepatology, Puerta de Hierro University Hospital, Madrid, Spain
| | - Gema Díaz
- Department of Pneumology, Puerta de Hierro University Hospital, Madrid, Spain
| | - Yago González-Lama
- Department of Gastroenterology and Hepatology, Puerta de Hierro University Hospital, Madrid, Spain
| |
Collapse
|
|
17
|
Carpio D, Jauregui-Amezaga A, de Francisco R, de Castro L, Barreiro-de Acosta M, Mendoza JL, Mañosa M, Ollero V, Castro B, González-Conde B, Hervías D, Sierra Ausin M, Sancho Del Val L, Botella-Mateu B, Martínez-Cadilla J, Calvo M, Chaparro M, Ginard D, Guerra I, Maroto N, Calvet X, Fernández-Salgado E, Gordillo J, Rojas Feria M. Tuberculosis in Anti-Tumour Necrosis Factor-treated Inflammatory Bowel Disease Patients After the Implementation of Preventive Measures: Compliance With Recommendations and Safety of Retreatment. J Crohns Colitis 2016; 10:1186-93. [PMID: 26802085 DOI: 10.1093/ecco-jcc/jjw022] [Citation(s) in RCA: 27] [Impact Index Per Article: 3.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 02/08/2023]
Abstract
BACKGROUND AND AIMS Despite having adopted preventive measures, tuberculosis (TB) may still occur in patients with inflammatory bowel disease (IBD) treated with anti-tumour necrosis factor (anti-TNF). Data on the causes and characteristics of TB cases in this scenario are lacking. Our aim was to describe the characteristics of TB in anti-TNF-treated IBD patients after the publication of the Spanish TB prevention guidelines in IBD patients and to evaluate the safety of restarting anti-TNF after a TB diagnosis. METHODS In this multicentre, retrospective, descriptive study, TB cases from Spanish hospitals were collected. Continuous variables were reported as mean and standard deviation or median and interquartile range. Categorical variables were described as absolute and relative frequencies and their confidence intervals when necessary. RESULTS We collected 50 TB cases in anti-TNF-treated IBD patients, 60% male, median age 37.3 years (interquartile range [IQR] 30.4-47). Median latency between anti-TNF initiation and first TB symptoms was 155.5 days (IQR 88-301); 34% of TB cases were disseminated and 26% extrapulmonary. In 30 patients (60%), TB cases developed despite compliance with recommended preventive measures; *not performing 2-step TST (tuberculin skin test) was the main failure in compliance with recommendations. In 17 patients (34%) anti-TNF was restarted after a median of 13 months (IQR 7.1-17.3) and there were no cases of TB reactivation. CONCLUSIONS Tuberculosis could still occur in anti-TNF-treated IBD patients despite compliance with recommended preventive measures. A significant number of cases developed when these recommendations were not followed. Restarting anti-TNF treatment in these patients seems to be safe.
Collapse
Affiliation(s)
- D Carpio
- Complexo Hospitalario Universitario de Pontevedra. Instituto de Investigación Biomédica Galicia Sur (IBI), Spain
| | | | | | - L de Castro
- Complexo Hospitalario Universitario, Vigo, Spain
| | | | | | - M Mañosa
- Hospital de Badalona, Barcelona, Spain
| | - V Ollero
- Hospital Universitario Arquitecto Marcide, Ferrol, Spain
| | - B Castro
- Hospital Universitario Marqués de Valdecilla, Santander, Spain
| | | | - D Hervías
- Hospital Virgen de Altagracia, Manzanares, Ciudad Real, Spain
| | | | | | | | | | - M Calvo
- Clínica Puerta de Hierro, Madrid, Spain
| | - M Chaparro
- Servicio de Aparato Digestivo, Hospital Universitario de La Princesa e Instituto de Investigación Sanitaria Princesa (IIS-IP), Madrid, Spain Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), Madrid, Spain
| | - D Ginard
- Hospital Son Espases, Palma de Mallorca, Spain
| | - I Guerra
- Hospital de Fuenlabrada, Madrid, Spain
| | - N Maroto
- Hospital de Manises, Valencia, Spain
| | - X Calvet
- Institut Universitàri Parc Taulí, Sabadell, Spain
| | - E Fernández-Salgado
- Complexo Hospitalario Universitario de Pontevedra. Instituto de Investigación Biomédica Galicia Sur (IBI), Spain
| | - J Gordillo
- Hospital Santa Creu i Sant Pau, Barcelona, Spain
| | | | | |
Collapse
|
|
18
|
López-Ibáñez M, Marín-Jiménez I. Niveles de fármaco y anticuerpos antifármaco en el manejo clínico del paciente con enfermedad inflamatoria intestinal. GASTROENTEROLOGIA Y HEPATOLOGIA 2016; 39:265-72. [DOI: 10.1016/j.gastrohep.2015.09.012] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Track Full Text] [Subscribe] [Scholar Register] [Received: 05/04/2015] [Revised: 06/25/2015] [Accepted: 09/15/2015] [Indexed: 02/08/2023]
|
|
19
|
Physician Perspectives on Unresolved Issues in the Management of Ulcerative Colitis: The UC Horizons Project. Inflamm Bowel Dis 2016; 22:583-98. [PMID: 26529561 DOI: 10.1097/mib.0000000000000617] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.1] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/18/2022]
Abstract
BACKGROUND There is still uncertainty about what constitutes the best therapeutic practice in ulcerative colitis (UC). OBJECTIVE The purpose of the "UC Horizons Project" was to raise a series of questions regarding the management of UC to provide responses based on the best scientific evidence available. METHODS The 11 members of the scientific committee prepared draft answers to the 10 questions from available evidence after a literature search. A total of 48 Spanish gastroenterology specialists nationwide participated in the project. The national meeting discussed the 10 issues in working groups and reached consensus regarding the recommendations by anonymous, interactive vote following the Delphi methodology. Final answers were developed, based on evidence and clinical experience of the participants. RESULTS All the recommendations achieved a high level of agreement in the plenary vote, although the quality of the evidence was markedly heterogeneous. The lowest percentage of agreement corresponded to the questions with the weakest level of evidence, highlighting the necessity of conducting further studies in these areas. The recommendations focused on (1) aminosalicylates therapy (regarding dose and appropriateness of coadministration with thiopurines), (2) corticosteroid therapy (regarding dose and route of administration), (3) thiopurine treatment (regarding indications and possibility of withdrawal), (4) anti-tumor necrosis factor therapy (regarding appropriateness of combination with thiopurines, intensification, or discontinuation of treatment), and (5) colorectal cancer (regarding risk and time trends). CONCLUSIONS The UC Horizons Project raised a series of eminently practical questions about the management of UC and provided responses based on the best scientific evidence available.
Collapse
|
|
20
|
Recomendaciones del Grupo Español de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa (GETECCU) sobre el cribado y tratamiento de la tuberculosis latente en pacientes con enfermedad inflamatoria intestinal. ACTA ACUST UNITED AC 2015. [DOI: 10.1016/j.eii.2015.09.001] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/31/2022]
|
|
21
|
Vedolizumab en el tratamiento de la enfermedad de Crohn. GASTROENTEROLOGIA Y HEPATOLOGIA 2015; 38:338-48. [DOI: 10.1016/j.gastrohep.2014.12.003] [Citation(s) in RCA: 11] [Impact Index Per Article: 1.1] [Reference Citation Analysis] [Track Full Text] [Subscribe] [Scholar Register] [Received: 11/10/2014] [Accepted: 12/05/2014] [Indexed: 12/22/2022]
|
|
22
|
Current incidence of active tuberculosis in IBD patients treated with anti-TNF agents: still room for improvement. J Crohns Colitis 2013; 7:e499-500. [PMID: 23689076 DOI: 10.1016/j.crohns.2013.04.021] [Citation(s) in RCA: 10] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 04/23/2013] [Accepted: 04/24/2013] [Indexed: 02/08/2023]
|
|
23
|
Gomollón F. Seguridad en el diagnóstico y tratamiento de la enfermedad inflamatoria intestinal. GASTROENTEROLOGIA Y HEPATOLOGIA 2013; 36 Suppl 2:15-20. [DOI: 10.1016/s0210-5705(13)70049-9] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 11/17/2022]
|