Colon to Rectum

Casanova MJ, Rubín de Célix C, Riestra S, Lucendo AJ, Benítez JM, Navarro-Llavat M, Barrio J, Morales-Alvarado VJ, Rivero M, Busquets D, Leo-Carnerero E, Nantes-Castillejo O, Navarro P, Van Domselaar M, Gutiérrez-Casbas A, Alonso-Abreu I, Barreiro-de Acosta M, Fernández-Salazar L, Iborra M, Martín-Arranz MD, García-Morales N, Guardiola J, Bouhmidi-Assakali A, Esteve M, Muñoz-Villafranca C, Rodríguez-Lago I, Ceballos D, Guerra I, Mañosa M, Marín-Jiménez I, Vera-Mendoza I, Garre A, Chaparro M, Gisbert JP; EXIT long-term study group of GETECCU

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

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. The authors analysed long-term outcomes of patients in sustained clinical remission from the start of EXIT.
Results: 125 patients (63 in MA and 62 in WA) were included. 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.

DOI:  10.1111/apt.70172