Post-marketing Surveillance of Tofacitinib in Patients With Ulcerative Colitis in Japan: A Post Hoc Analysis of Safety and Effectiveness by Prior Biologic Status.

ABSTRACT:

Background

This post hoc analysis of a 60-week post-marketing surveillance (PMS) study in Japan assessed tofacitinib safety and effectiveness in patients with ulcerative colitis (UC), stratified by prior biologic exposure.

Methods

The PMS study registered all patients with UC receiving tofacitinib in Japan (May 2018-June 2021). Outcomes included the proportion of patients with clinically important adverse events (AEs), incidence rates (IR; unique patients with events/100 patient-years of exposure) of clinically important AEs, reasons for discontinuation, and effectiveness (partial Mayo score remission). Patients were stratified by prior biologic exposure (biologic-experienced/biologic-naïve). Prior biologics included infliximab, adalimumab, golimumab, and others (eg, ustekin

SUBMITTER: Matsuoka K 

PROVIDER: S-EPMC12712959 | biostudies-literature | 2025 Oct

REPOSITORIES: biostudies-literature