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Withdrawal of antitumour necrosis factor in inflammatory bowel disease patients in remission: a randomised placebo-controlled clinical trial of GETECCU

2024; BMJ; Linguagem: Inglês

10.1136/gutjnl-2024-333385

1468-3288

Javier P. Gisbert, María G. Donday, Sabino Riestra, Alfredo J. Lucendo, J M Benítez, Mercè Navarro-Llavat, Jesús Barrio, Víctor Jair Morales-Alvarado, Montserrat Rivero, David Busquets, Eduardo Leo Carnerero, Olga Merino, Óscar Nantes, Pablo Navarro, Manuel Van Domselaar, Ana Gutiérrez, Inmaculada Alonso-Abreu, Rafael Mejuto, Luís 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, Míriam Mañosa, Ignacio Marín Jiménez, Emilio Torrella, Meg Mendoza, María José Casanova, Ruth de Francisco, Laura Arias‐González, S 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 Boscá-Watts, Isabel Blázquez, Diana Acosta, A Garre, Montserrat Baldán‐Martín, Concepción Martínez, Manuel Barreiro‐de Acosta, Eugeni Domènech, María Esteve, Valle García-Sánchez, Pilar Nos, Julián Panés, María Chaparro,

Helicobacter pylori-related gastroenterology studies

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