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

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

Fecha de publicación: Fecha Ahead of Print:

Autores de IIS La Fe

Participantes ajenos a IIS La Fe

  • 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
  • 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
  • Panés J
  • EXIT Study group of GETECCU

Grupos

Abstract

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.

© 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.

Datos de la publicación

ISSN/ISSNe:
0017-5749, 1468-3288

GUT  BMJ PUBLISHING GROUP

Tipo:
Article
Páginas:
387-396
PubMed:
39794921
Factor de Impacto:
7,885 SCImago ℠
Cuartil:
Q1 SCImago ℠

Citas Recibidas en Web of Science: 19

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Keywords

  • INFLAMMATORY BOWEL DISEASE; INFLIXIMAB; ULCERATIVE COLITIS

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