Clinical Outcomes for Patients With Ulcerative Colitis in Cases of Withdrawal and Resumption of Janus Kinase Inhibitors: Multicenter Cohort Study.

Abstract

Background: Janus kinase inhibitors (JAKis) have revolutionized ulcerative colitis (UC) management; however, the consequences of treatment discontinuation in patients achieving clinical remission remain poorly understood. This study investigated the clinical outcomes following JAKi discontinuation and retreatment effectiveness in patients with relapse.

Methods: In this multicenter retrospective cohort study, we analyzed 101 patients with UC who received their first JAKi treatment between 2018 and 2024. Among them, 53 who achieved remission (Patient-Reported Outcome 2 = 0) in week 8 were included. The primary endpoint was a comparison of relapse-free survival between the treatment continuation and discontinuation groups (n = 37 and 16, respectively). The secondary endpoints included assessment of post-discontinuation remission maintenance and post-retreatment remission rates.

Results: The proportion of female patients in the discontinuation group (68.8%) was higher (P = .0478) than the continuation group (40.5%). The mean relapse-free survival was significantly longer in the continuation group than in the discontinuation group (1679 vs 882 days, cumulative relapse-free rate 83.3% vs 13.6%, P < .001, respectively). In the latter, 13 patients experienced relapse during follow-up (post-discontinuation mean relapse-free survival: 326 days), although all patients remained in clinical and biological remission. Notably, among patients who received JAKi retreatment, 83.3% achieved remission in week 8.

Conclusions: To our knowledge, this is the first real-world study to evaluate the effects of JAKi discontinuation on the outcomes for patients with UC. JAKi discontinuation in patients in remission was associated with a high relapse risk. JAKi retreatment was highly effective in patients who experienced relapse after treatment discontinuation, providing valuable evidence for managing treatment interruption.