EXIT Study group of GETECCU2026-01-272026-01-272025-03-01EXIT Study group of GETECCU 2025, 'Withdrawal of antitumour necrosis factor in inflammatory bowel disease patients in remission : a randomised placebo-controlled clinical trial of GETECCU', Gut, vol. 74, no. 3, pp. 387-396. https://doi.org/10.1136/gutjnl-2024-3333850017-5749PubMedCentral: PMC11874338unpaywall: 10.1136/gutjnl-2024-333385https://hdl.handle.net/10641/7549Publisher Copyright: © Author(s) (or their employer(s)) 2025. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ Group.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.101560066enghttp://creativecommons.org/licenses/by-nc-nd/4.0/INFLAMMATORY BOWEL DISEASEINFLIXIMABULCERATIVE COLITISGastroenterologyJournal ArticleRandomized Controlled TrialMulticenter StudyYesyesjournal articleopen access10.1136/gutjnl-2024-333385https://www.scopus.com/pages/publications/85214805526https://www.scopus.com/pages/publications/85214805526#tab=citedBy