Withdrawal of antitumour necrosis factor in inflammatory bowel disease patients in remission: a randomised placebo-controlled clinical trial of GETECCU
Javier P Gisbert, María G Donday, Sabino Riestra, Alfredo J Lucendo, José-Manuel Benítez, Mercè Navarro-Llavat, Jesús Barrio, Víctor J Morales-Alvarado, Montserrat Rivero, David Busquets, Eduardo Leo Carnerero, Olga Merino, Óscar Nantes Castillejo, Pablo Navarro, Manuel Van Domselaar, Ana Gutiérrez, Inmaculada Alonso-Abreu, Rafael Mejuto, Luis Fernández-Salazar, Marisa Iborra, María Dolores Martín-Arranz, Juan Ramón Pineda, Manuela Josefa Sampedro, Katja Serra Nilsson, Abdel Bouhmidi, Lissette Batista, Carmen Muñoz Villafranca, Iago Rodríguez-Lago, Daniel Ceballos, Iván Guerra, Miriam Mañosa, Ignacio Marín Jiménez, Emilio Torrella, Maribel Vera Mendoza, María José Casanova, Ruth de Francisco, Laura Arias-González, Sandra Marín Pedrosa, Orlando García-Bosch, Francisco Javier García-Alonso, Pedro Delgado-Guillena, María José García, Leyanira Torrealba, Andrea Núñez-Ortiz, Miren Vicuña Arregui, Marta Maia Bosca-Watts, Isabel Blázquez, Diana Acosta, Ana Garre, Montse Baldán, Concepción Martínez, Manuel Barreiro-de Acosta, Eugeni Domènech, Maria Esteve, Valle García-Sánchez, Pilar Nos, Julián Panés, María Chaparro
{"title":"Withdrawal of antitumour necrosis factor in inflammatory bowel disease patients in remission: a randomised placebo-controlled clinical trial of GETECCU","authors":"Javier P Gisbert, María G Donday, Sabino Riestra, Alfredo J Lucendo, José-Manuel Benítez, Mercè Navarro-Llavat, Jesús Barrio, Víctor J Morales-Alvarado, Montserrat Rivero, David Busquets, Eduardo Leo Carnerero, Olga Merino, Óscar Nantes Castillejo, Pablo Navarro, Manuel Van Domselaar, Ana Gutiérrez, Inmaculada Alonso-Abreu, Rafael Mejuto, Luis Fernández-Salazar, Marisa Iborra, María Dolores Martín-Arranz, Juan Ramón Pineda, Manuela Josefa Sampedro, Katja Serra Nilsson, Abdel Bouhmidi, Lissette Batista, Carmen Muñoz Villafranca, Iago Rodríguez-Lago, Daniel Ceballos, Iván Guerra, Miriam Mañosa, Ignacio Marín Jiménez, Emilio Torrella, Maribel Vera Mendoza, María José Casanova, Ruth de Francisco, Laura Arias-González, Sandra Marín Pedrosa, Orlando García-Bosch, Francisco Javier García-Alonso, Pedro Delgado-Guillena, María José García, Leyanira Torrealba, Andrea Núñez-Ortiz, Miren Vicuña Arregui, Marta Maia Bosca-Watts, Isabel Blázquez, Diana Acosta, Ana Garre, Montse Baldán, Concepción Martínez, Manuel Barreiro-de Acosta, Eugeni Domènech, Maria Esteve, Valle García-Sánchez, Pilar Nos, Julián Panés, María Chaparro","doi":"10.1136/gutjnl-2024-333385","DOIUrl":null,"url":null,"abstract":"Background and objectives Primary objectives: to compare the rates of sustained clinical remission at 12 months in patients treated with antitumour necrosis factor (anti-TNF) and immunomodulators who withdraw anti-TNF treatment versus those who maintain it. Secondary objectives: to evaluate the effect of anti-TNF withdrawal on relapse-free time, endoscopic and radiological activity, safety, quality of life and work productivity; and to identify predictive factors for relapse. Design Prospective, quadruple-blind, multicentre, randomised, controlled trial. Patients with ulcerative colitis or Crohn’s disease in clinical remission for >6 months and absence of severe endoscopic (and radiological in Crohn’s disease) lesions were randomised to maintain anti-TNF treatment (maintenance arm (MA)) or to withdraw it (withdrawal arm (WA)). All patients maintained immunomodulators. Patients were followed-up until month 12 or up to clinical relapse. Results One-hundred forty patients were randomised: 70 were allocated to the MA and 70 to the WA. The proportion of patients with sustained clinical remission at 12 months was similar in the MA and WA: 59/70 (84%), 95% CI=74% to 92% versus 53/70 (76%), 95% CI=64% to 85%. The proportion of patients with significant endoscopic lesions at the end of follow-up was 8.5% in the MA and 19% in the WA (p=0.1); a higher proportion of patients had faecal calprotectin >250 µg/g at the end of follow-up in the WA (p=0.01). The same percentage of patients in both groups had at least one adverse event (69%). The proportion of patients with serious adverse events was also similar in both groups (4% in MA vs 7% in WA). Conclusion Anti-TNF withdrawal in selected patients with IBD in clinical, endoscopic and radiological remission has no impact on sustained clinical remission at 1 year although objective markers of activity were higher in patients who withdrew treatment. Trial registration number <https://www.clinicaltrialsregister.eu/ctr-search/search?query=2015-001410-10> <https://clinicaltrials.gov/study/NCT02994836> Data are available upon reasonable request.","PeriodicalId":12825,"journal":{"name":"Gut","volume":"111 1","pages":""},"PeriodicalIF":23.0000,"publicationDate":"2024-12-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Gut","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1136/gutjnl-2024-333385","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"GASTROENTEROLOGY & HEPATOLOGY","Score":null,"Total":0}
引用次数: 0
Abstract
Background and objectives Primary objectives: to compare the rates of sustained clinical remission at 12 months in patients treated with antitumour necrosis factor (anti-TNF) and immunomodulators who withdraw anti-TNF treatment versus those who maintain it. Secondary objectives: to evaluate the effect of anti-TNF withdrawal on relapse-free time, endoscopic and radiological activity, safety, quality of life and work productivity; and to identify predictive factors for relapse. Design Prospective, quadruple-blind, multicentre, randomised, controlled trial. Patients with ulcerative colitis or Crohn’s disease in clinical remission for >6 months and absence of severe endoscopic (and radiological in Crohn’s disease) lesions were randomised to maintain anti-TNF treatment (maintenance arm (MA)) or to withdraw it (withdrawal arm (WA)). All patients maintained immunomodulators. Patients were followed-up until month 12 or up to clinical relapse. Results One-hundred forty patients were randomised: 70 were allocated to the MA and 70 to the WA. The proportion of patients with sustained clinical remission at 12 months was similar in the MA and WA: 59/70 (84%), 95% CI=74% to 92% versus 53/70 (76%), 95% CI=64% to 85%. The proportion of patients with significant endoscopic lesions at the end of follow-up was 8.5% in the MA and 19% in the WA (p=0.1); a higher proportion of patients had faecal calprotectin >250 µg/g at the end of follow-up in the WA (p=0.01). The same percentage of patients in both groups had at least one adverse event (69%). The proportion of patients with serious adverse events was also similar in both groups (4% in MA vs 7% in WA). Conclusion Anti-TNF withdrawal in selected patients with IBD in clinical, endoscopic and radiological remission has no impact on sustained clinical remission at 1 year although objective markers of activity were higher in patients who withdrew treatment. Trial registration number Data are available upon reasonable request.
期刊介绍:
Gut is a renowned international journal specializing in gastroenterology and hepatology, known for its high-quality clinical research covering the alimentary tract, liver, biliary tree, and pancreas. It offers authoritative and current coverage across all aspects of gastroenterology and hepatology, featuring articles on emerging disease mechanisms and innovative diagnostic and therapeutic approaches authored by leading experts.
As the flagship journal of BMJ's gastroenterology portfolio, Gut is accompanied by two companion journals: Frontline Gastroenterology, focusing on education and practice-oriented papers, and BMJ Open Gastroenterology for open access original research.