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
Journal: Gut (2024)

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 &gt;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 &gt;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