Post-marketing surveillance of tofacitinib in patients with ulcerative colitis in Japan: a final report of safety and effectiveness data.

ABSTRACT:

Background

We present the final analysis of a tofacitinib post-marketing surveillance (PMS) study in Japanese patients with ulcerative colitis (UC).

Methods

Safety/effectiveness data were evaluated (through Sept/30/2022). All patients with UC in Japan receiving tofacitinib were registered (60-week observation period). Adverse events (AEs) were recorded. Per protocol, several AEs were identified as clinically important/potential risks; all treatment-period data were used to calculate incidence rates (IRs; unique patients with events/100 patient-years [PY] of exposure). Effectiveness was assessed (partial/total Mayo score), with last observation carried forward for imputation of missing data.

Results

Overall, 2043 patients were enrolled (safety analysis set: n = 1982/ef

SUBMITTER: Matsuoka K 

PROVIDER: S-EPMC12289845 | biostudies-literature | 2025 Aug

REPOSITORIES: biostudies-literature