Investigation of the Clinical Remission Course in Ulcerative Colitis from Tofacitinib Induction to Tapering or Withdrawal in Japanese Patients: A Single-Center Retrospective Study.

Abstract

Introduction: Tofacitinib (TOF), a Janus kinase inhibitor, has emerged as an innovative treatment option for patients with moderate-to-severe ulcerative colitis (UC). However, the clinical course of patients who achieve induction and maintain remission followed by TOF tapering or withdrawal is unclear. We investigated the efficacy of TOF and the clinical course after TOF tapering or withdrawal in real-world clinical practice.

Method: Thirty-two patients treated with TOF 20 mg/day for UC relapse between October 2018 and August 2023 were included in this single-center, retrospective observational study. Disease activity was defined by partial Mayo score (PMS), and remission was defined as PMS ≤2 and rectal bleeding score 0, other score ≤1. PMS before TOF 20 mg/day induction was compared with PMS at 8 weeks. Patients who achieved clinical remission were tapered to 10 mg/day, while those who requested for drug withdrawal were allowed. The relapse rate of the TOF 10 mg/day maintenance group and the TOF withdrawal group was compared. Both groups included patients who had maintained remission at 6 months after tapering TOF to 10 mg/day. In addition, the efficacy of TOF 20 mg/day reinduction therapy was also compared between patients who relapsed in the TOF 10 mg/day maintenance group and the TOF withdrawal group.

Result: Twenty-three patients (71.9%) achieved induction of remission by 8 weeks after TOF 20 mg/day administration, with significantly lower PMS than before TOF (p < 0.0001). Ultimately, 27 patients (84.4%) achieved remission, 24 who achieved remission were tapered to 10 mg/day, whereas 18 were able to maintain remission for 6 months. Seven of the 18 eventually withdrew from TOF. There was no significant difference in relapse rates between the TOF 10 mg/day maintenance group (n = 11; follow-up, 525 [29-1,483] days) and the TOF withdrawal group (n = 7; follow-up, 284 [77-797] days) (5/11 [45.5%] vs. 3/7 [42.9%], log-rank test: p = 0.7091). All patients who received TOF 20 mg/day reintroduction therapy after relapse went into remission.

Conclusion: In clinical practice, TOF 20 mg/day significantly induced induction of remission, and in patients who received 6 months of maintenance remission therapy with TOF 10 mg/day, the relapse rates between the TOF 10 mg/day maintenance group and the TOF withdrawal group were similar. After relapse, TOF 20 mg/day reintroduction therapy improved symptoms.