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. 2025 Mar 22;7(2):otaf020.
doi: 10.1093/crocol/otaf020. eCollection 2025 Apr.

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

Yasuki Sano  1 , Yuka Ito  1 , Naoto Yagi  1 , Yusuke Honzawa  1 , Norimasa Fukata  1 , Makoto Naganuma  1
Affiliations

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

Yasuki Sano et al. Crohns Colitis 360. .

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.

Keywords: JAK inhibitors; relapse; remission; treatment discontinuation; ulcerative colitis.

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Conflict of interest statement

M.N. received grants from AbbVie GK, Alfresa Pharma Corporation, KYORIN Pharmaceutical Co., Ltd., Mochida Pharmaceutical Co., Ltd., Mitsubishi Tanabe Pharmaceutical Co., Ltd., and MIYARISAN Pharmaceutical Co. Ltd. and lecture fees from EA Pharma Co., Ltd., Gilead Science Inc., Takeda Pharmaceutical Co., Ltd., AbbVie GK, Janssen Pharmaceutical K.K., Mitsubishi Tanabe Pharmaceutical Co., Ltd., JIMRO Co., Ltd., KYORIN Pharmaceutical Co., Ltd., Mochida Pharmaceutical Co., Ltd., and Pfizer Co., Ltd, outside of the submitted work.

Figures

Graphical Abstract
Graphical Abstract
Figure 1.
Figure 1.
Overall rate of cumulative remission maintenance. Only patients with Patients Report Outcomes 2 of 0 at week 8 were collected as remission maintenance.
Figure 2.
Figure 2.
Progress in cases in which clinical remission was achieved at 8 weeks and Janus kinase inhibitors were continued.
Figure 3.
Figure 3.
Kaplan-Meier analysis of the rate of cumulative relapse-free survival in patients in the continuation group vs the discontinuous group.
Figure 4.
Figure 4.
Periods of Janus kinase inhibitor (JAKi) treatment and discontinuation for each of the cases in which JAKis were discontinued.
Figure 5.
Figure 5.
Clinical outcomes in cases of relapse after the discontinuation of Janus kinase inhibitors.
See this image and copyright information in PMC

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