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Randomized Controlled Trial
. 2025 Jul;62(1):59-71.
doi: 10.1111/apt.70172. Epub 2025 May 2.

Long-Term Outcomes Following Withdrawal of Anti-Tumour Necrosis Factor Treatment in Inflammatory Bowel Disease Patients in Remission: The Exit Long-Term Study of GETECCU

María José Casanova  1 , Cristina Rubín de Célix  1 , Sabino Riestra  2 , Alfredo J Lucendo  3 , José Manuel Benítez  4 , Mercè Navarro-Llavat  5 , Jesús Barrio  6 , Víctor J Morales-Alvarado  7 , Montserrat Rivero  8 , David Busquets  9 , Eduardo Leo-Carnerero  10 , Oscar Nantes-Castillejo  11 , Pablo Navarro  12 , Manuel Van Domselaar  13 , Ana Gutiérrez-Casbas  14 , Inmaculada Alonso-Abreu  15 , Manuel Barreiro-de Acosta  16 , Luis Fernández-Salazar  17 , Marisa Iborra  18 , María Dolores Martín-Arranz  19 , Natalia García-Morales  20   21 , Jordi Guardiola  22 , Abdel Bouhmidi-Assakali  23 , María Esteve  24 , Carmen Muñoz-Villafranca  25 , Iago Rodríguez-Lago  26 , Daniel Ceballos  27 , Iván Guerra  28 , Miriam Mañosa  29 , Ignacio Marín-Jiménez  30 , Isabel Vera-Mendoza  31 , Ana Garre  1 , María Chaparro  1 , Javier P Gisbert  1 ; EXIT long‐term study group of GETECCU
Collaborators, Affiliations
Randomized Controlled Trial

Long-Term Outcomes Following Withdrawal of Anti-Tumour Necrosis Factor Treatment in Inflammatory Bowel Disease Patients in Remission: The Exit Long-Term Study of GETECCU

María José Casanova et al. Aliment Pharmacol Ther. 2025 Jul.

Abstract

Background: The EXIT trial found no difference in sustained remission at 12 months between inflammatory bowel disease (IBD) patients in remission who withdrew anti-TNF therapy [withdrawal arm (WA)] and those who maintained treatment [maintenance arm (MA)].

Aims: To compare the long-term risk of relapse between these groups and assess the response to anti-TNF resumption.

Methods: This was a follow-up extension of the EXIT trial. We analysed long-term outcomes of patients in sustained clinical remission from the start of EXIT.

Results: We included 125 patients (63 in MA and 62 in WA). Median follow-up was 12 months for MA and 26 months for WA. The cumulative incidence of relapse (95% CI) was 35% (23%-48%) in MA and 47% (34%-60%) in WA; p = 0.3. In MA, relapses occurred in 8% of patients by 12 months and 47% by 24 months. In WA, relapses occurred in 16% by 12 months and 39% by 24 months. The incidence rate of relapse per patient-year was 22% in MA and 19% in WA. Baseline faecal calprotectin > 250 μg/g was the only variable associated with a higher risk of relapse. Of the 29 patients who relapsed in WA, 26 (90%) resumed anti-TNF therapy; of these, 69% regained clinical remission.

Conclusion: In this extended analysis of patients included in the EXIT trial, withdrawing anti-TNF therapy in patients with IBD in remission was not associated with a higher long-term relapse risk.

Keywords: Crohn's disease; anti‐TNF; inflammatory bowel disease; maintenance; ulcerative colitis.

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References

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