2026-04-13T13:15:53Zhttps://recercat.cat/oai/request
oai:recercat.cat:11351/130732025-10-24T10:59:57Zcom_2072_451665com_2072_378040col_2072_451666
RECERCAT author Gisbert, Javier Pérez author Donday, María G author Riestra Menéndez, Sabino author Benitez, Jose Manuel author Navarro-Llavat, Mercè author Busquets, David author Serra Nilsson, Katja author Lucendo, Alfredo J author Morales Alvarado, Víctor Jair 2025-10-24T10:59:57Z 2025-10-24T10:59:57Z 2025-05-12T10:15:28Z2025-05-12T10:15:28Z2025-02-06 http://hdl.handle.net/11351/13073 Inflammatory bowel disease; Inflixmab; Ulcerative colitisEnfermedad inflamatoria intestinal; Inflixmab; Colitis ulcerosaMalaltia inflamatòria intestinal; Inflixmab; Colitis ulcerosaPrimary 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. 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. 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. 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). 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. https://www.clinicaltrialsregister.eu/ctr-search/search?query=2015-001410-10 https://clinicaltrials.gov/study/NCT02994836.This work has been supported by the Plataforma ISCIII de Soporte para la Investigación Clínica - SCReN (Spanish Clinical Research Network), funded by the Instituto de Salud Carlos III (ISCIII) through projects PT13/0002/0027 and PT17/0017/0017, both integrated in the Plan Estatal de I+D+I 2013-2016 and cofunded by the European Regional Development Fund (FEDER) ’A way to make Europe’, and project PT23/00060, funded by the ISCIII and cofunded by the European Union. Attribution-NonCommercial 4.0 International https://creativecommons.org/licenses/by-nc/4.0/ info:eu-repo/semantics/openAccess Aparell digestiu - Malalties Colitis ulcerosa Malalties - Recaiguda DISEASES::Digestive System Diseases::Gastrointestinal Diseases::Gastroenteritis::Inflammatory Bowel Diseases DISEASES::Digestive System Diseases::Gastrointestinal Diseases::Gastroenteritis::Colitis::Colitis, Ulcerative CHEMICALS AND DRUGS::Amino Acids, Peptides, and Proteins::Proteins::Blood Proteins::Immunoproteins::Immunoglobulins::Antibodies::Antibodies, Monoclonal::Infliximab ENFERMEDADES::enfermedades del sistema digestivo::enfermedades gastrointestinales::gastroenteritis::enfermedad inflamatoria intestinal ENFERMEDADES::enfermedades del sistema digestivo::enfermedades gastrointestinales::gastroenteritis::colitis::colitis ulcerosa COMPUESTOS QUÍMICOS Y DROGAS::aminoácidos, péptidos y proteínas::proteínas::proteínas sanguíneas::inmunoproteínas::inmunoglobulinas::anticuerpos::anticuerpos monoclonales::infliximab Withdrawal of antitumour necrosis factor in inflammatory bowel disease patients in remission: a randomised placebo-controlled clinical trial of GETECCU info:eu-repo/semantics/article info:eu-repo/semantics/publishedVersion