Withdrawal of antitumour 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 antitumour necrosis factor (anti-TNF) and immunomodulators who withdraw anti-TNF treatment versus those who maintain it. SECONDARY OBJECTIVES: to evaluate the eff...

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Autores: 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
Tipo de recurso: artículo
Estado:Versión publicada
Fecha de publicación:2025
País:España
Institución:Instituto de Investigación Biomédica y Sanitaria de Alicante (ISABIAL)
Repositorio:r-ISABIAL. Repositorio Institucional de Producción Científica del Instituto de Investigación Biomédica y Sanitaria de Alicante
OAI Identifier:oai:dnet:isabial_____::8e6f05ebad1c2130547a7799af7da2e9
Acceso en línea:https://isabial.portalinvestigacion.com/publicaciones12651
https://gut.bmj.com/content/74/3/387
Access Level:acceso abierto
Palabra clave:INFLAMMATORY BOWEL DISEASE
INFLIXIMAB
ULCERATIVE COLITIS
Descripción
Sumario: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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