ArticleCrohn's & colitis 3602025
Post-marketing Surveillance of Tofacitinib in Patients With Ulcerative Colitis in Japan: A Post Hoc Analysis of Safety and Effectiveness by Prior Biologic Status.
Article in Crohn's & colitis 360, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03643211 (XELJANZ), which is not on this map. Not yet cited in PubMed.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
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Xeljanz(registered) tablets 5 mg special investigation(investigation of long-term use in patients with ulcerative colitis)
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11 authors.
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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, ustekinumab/vedolizumab). Results: Overall, 1367 biologic-experienced and 615 biologic-naïve patients were included. More biologic-naïve versus biologic-experienced patients (30.6% vs. 16.9%) had disease duration <2 years. Proportions of AEs were similar between groups, although IRs (95% confidence intervals) were numerically higher in biologic-experienced versus biologic-naïve patients for herpes zoster (HZ; 6.77 [5.30, 8.53] vs. 4.10 [2.50, 6.33]) and serious infections (SI; 1.92 [1.19, 2.94] vs. 0.60 [0.12, 1.77]). Insufficient clinical response (biologic-experienced: 53.3%; biologic-naïve: 38.9%) was the primary reason for discontinuation. At week 60, remission rates were 63.07% for biologic-naïve patients and 56.37% for biologic-experienced patients. Conclusions: Safety was generally similar between biologic-experienced and biologic-naïve patients, although HZ and SI IRs were numerically higher in biologic-experienced patients. Remission rates were numerically higher in biologic-naïve versus biologic-experienced patients, although differences were small. Discontinuation was mostly due to insufficient clinical response. Missing concomitant corticosteroid/tofacitinib dose data and endoscopic assessment might limit the analysis. ClinicalTrialsgov: NCT03643211.
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