Withdrawal of antitumour necrosis factor in inflammatory bowel disease patients in remission: a randomised placebo-controlled clinical trial of GETECCU
Authors: Gisbert Javier P , Donday María G , Riestra Sabino , Lucendo Alfredo J , Benítez José-Manuel , Navarro-Llavat Mercè , Barrio Jesús , Morales-Alvarado Víctor J , Rivero Montserrat , Busquets David , Leo Carnerero Eduardo , Merino Olga , Nantes Castillejo Óscar , Navarro Pablo , Van Domselaar Manuel , Gutiérrez Ana , Alonso-Abreu Inmaculada , Mejuto Rafael , Fernández-Salazar Luis , Iborra Marisa , Martín-Arranz María Dolores , Pineda Juan Ramón , Sampedro Manuela Josefa , Serra Nilsson Katja , Bouhmidi Abdel , Batista Lissette , Muñoz Villafranca Carmen , Rodríguez-Lago Iago , Ceballos Daniel , Guerra Iván , Mañosa Miriam , Marín Jiménez Ignacio , Torrella Emilio , Vera Mendoza Maribel , Casanova María José , de Francisco Ruth , Arias-González Laura , Marín Pedrosa Sandra , García-Bosch Orlando , García-Alonso Francisco Javier , Delgado-Guillena Pedro , García María José , Torrealba Leyanira , Núñez-Ortiz Andrea , Vicuña Arregui Miren , Bosca-Watts Marta Maia , Blázquez Isabel , Acosta Diana , Garre Ana , Baldán Montse , Martínez Concepción , Barreiro-de Acosta Manuel , Domènech Eugeni , Esteve Maria , García-Sánchez Valle , Nos Pilar , Panés Julián , Chaparro María 
Published: December 2024

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