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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 con afiliación ISPA

Otros autores

  • Donday, MG
  • Lucendo, AJ
  • Benitez, JM
  • Navarro-Llavat, M
  • Barrio, J
  • Morales-Alvarado, VJ
  • Rivero, M
  • Busquets, D
  • Carnerero, EL
  • Merino, O
  • Castillejo, ON
  • Navarro, P
  • Van Domselaar, M
  • Gutierrez, A
  • Alonso-Abreu, I
  • Mejuto, R
  • Fernandez-Salazar, L
  • Iborra, M
  • Martin-Arranz, MD
  • Pineda, JR
  • Sampedro, MJ
  • Nilsson, KS
  • Bouhmidi, A
  • Batista, L
  • Villafranca, CM
  • Rodriguez-Lago, I
  • Ceballos, D
  • Guerra, I
  • Manosa, M
  • Jimenez, IM
  • Torrella, E
  • Mendoza, MV
  • Casanova, MJ
  • Arias-Gonzalez, L
  • Pedrosa, SM
  • Garcia-Bosch, O
  • Garcia-Alonso, FJ
  • Delgado-Guillena, P
  • Garcia, MJ
  • Torrealba, L
  • Nunez-Ortiz, A
  • Arregui, MV
  • Bosca-Watts, MM
  • Blazquez, I
  • Acosta, D
  • Garre, A
  • Baldan, M
  • Martinez, C
  • Acosta, MBD
  • Domenech, E
  • Esteve, M
  • Garcia-Sanchez, V
  • Nos, P
  • Panes, J
  • Chaparro, M

Grupos y Plataformas

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 mu g/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.

Datos de la publicación

ISSN/ISSNe:
0017-5749, 1468-3288

GUT  BMJ PUBLISHING GROUP

Tipo:
Article
Páginas:
-
PubMed:
39794921

Citas Recibidas en Web of Science: 6

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Keywords

  • INFLAMMATORY BOWEL DISEASE; INFLIXIMAB; ULCERATIVE COLITIS

Financiación

Abbvie
Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa
Instituto de Salud Carlos III (FI16/00386)
PI15/00560

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