Colon to Rectum

Gut. 2025;74(3):387-396

Gisbert JP, Donday MG, Riestra S, Lucendo AJ, Benítez JM, Navarro-Llavat M, Barrio J, Morales-Alvarado VJ, Rivero M, Busquets D, Leo Carnerero E, Merino O, Nantes Castillejo Ó, Navarro P, Van Domselaar M, Gutiérrez A, Alonso-Abreu I, Mejuto R, Fernández-Salazar L, Iborra M, Martín-Arranz MD, Pineda JR, Sampedro MJ, Serra Nilsson K, Bouhmidi A, Batista L, Muñoz Villafranca C, Rodríguez-Lago I, Ceballos D, Guerra I, Mañosa M, Marín Jiménez I, Torrella E, Vera Mendoza M, Casanova MJ, de Francisco R, Arias-González L, Marín Pedrosa S, García-Bosch O, García-Alonso FJ, Delgado-Guillena P, García MJ, Torrealba L, Núñez-Ortiz A, Vicuña Arregui M, Bosca-Watts MM, Blázquez I, Acosta D, Garre A, Baldán M, Martínez C, Barreiro-de Acosta M, Domènech E, Esteve M, García-Sánchez V, Nos P, Panés J, Chaparro M; EXIT Study group of GETECCU

Withdrawal of anti-tumour necrosis factor in inflammatory bowel disease patients in remission: A randomised placebo-controlled clinical trial of GETECCU

Background and objectives: Primary objectives: to compare the rates of sustained clinical remission at 12 months in patients treated with anti-tumour 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: 140 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 of 70 (84%), 95% confidence interval (CI): 74–92% versus 53 of 70 (76%), 95% CI: 64–85%. 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 1 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-tumour necrosis factor withdrawal in selected patients with inflammatory bowel disease 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.

DOI:  10.1136/gutjnl-2024-333385