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Original Article
- IBD
- Post-marketing surveillance of tofacitinib in patients with ulcerative colitis in Japan: a post hoc analysis of safety and effectiveness in older (≥65 years) and younger (<65 years) patients
- Katsuyoshi Matsuoka, Takayuki Yamamoto, Minoru Matsuura, Toshimitsu Fujii, Shoko Arai, Yutaka Endo, Keiko Sato, Hirotoshi Yuasa, Yasushi Mizuno, Yuki Kobayashi, Tadakazu Hisamatsu
- Intest Res 2026;24(2):214-224. Published online November 10, 2025
- DOI: https://doi.org/10.5217/ir.2025.00058
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Abstract
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Supplementary Material
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ePub - Background/Aims
To assess, post hoc, tofacitinib safety/effectiveness in patients with ulcerative colitis (UC), stratified by age, using data from a 60-week post-marketing surveillance (PMS) study in Japan.
Methods
All patients with UC receiving tofacitinib in Japan were enrolled in a large PMS study. Incidence proportions of adverse events (AEs), incidence rates (IRs; unique patients with events/100 patient-years of exposure) of clinically important AEs, reasons for discontinuation, and partial Mayo score clinical remission, stratified by age ( ≥ 65 and < 65 years), were evaluated.
Results
The analysis included 212 older ( ≥ 65 years) and 1,770 younger ( < 65 years) patients. Demographics and baseline disease characteristics were generally similar between groups; however, more older versus younger patients had cardiovascular disease (23.1% vs. 4.6%). Incidence proportions of AEs were comparable between groups, but IRs (95% confidence intervals) in older versus younger patients were numerically higher for herpes zoster (9.81 [5.72–15.71] vs. 5.44 [4.28–6.82]), and higher for serious infections (4.45 [1.92–8.76] vs. 1.14 [0.65–1.85]). More older versus younger patients discontinued due to AEs (28.6% vs. 17.6%); more younger versus older patients discontinued due to insufficient clinical responses (50.3% vs. 35.2%). Clinical remission rates through 60 weeks were generally similar between groups.
Conclusions
Older patients had higher IRs of herpes zoster and serious infection than younger patients, although tofacitinib effectiveness was similar between age groups. Discontinuation due to AEs was more common in older patients. Despite the smaller sample size of older versus younger patients, a focused evaluation of older patients is of benefit. -
Citations
Citations to this article as recorded by
- Tofacitinib in older patients with ulcerative colitis: balancing efficacy and safety
Yoon Suk Jung
Intestinal Research.2026; 24(2): 193. CrossRef
- Tofacitinib in older patients with ulcerative colitis: balancing efficacy and safety
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