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

医学 内科学 不利影响 克罗恩病 安慰剂 溃疡性结肠炎 外科 炎症性肠病 胃肠病学 临床试验 钙蛋白酶 粪钙保护素 随机对照试验 疾病 病理 替代医学
作者
Javier P. Gisbert,María G. Donday,Sabino Riestra,Alfredo J. Lucendo,J M Benítez,M 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,Luis Fernández‐Salazar,Marisa Iborra
出处
期刊:Gut [BMJ]
卷期号:: gutjnl-333385 被引量:1
标识
DOI:10.1136/gutjnl-2024-333385
摘要

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
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