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

Q: What question did this study set out to answer?

To evaluate the safety and effectiveness of tofacitinib in older and younger patients with ulcerative colitis.

Katsuyoshi Matsuoka; Takayuki Yamamoto; Minoru Matsuura; Toshimitsu Fujii; Shoko Arai; Yutaka Endo; Keiko Sato; Hirotoshi Yuasa; YASUSHI MIZUNO; Yuki Kobayashi; Tadakazu Hisamatsu

doi:10.5217/ir.2025.00058

November 10, 2025Intestinal ResearchOpen Access

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

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Key Points

To evaluate the safety and effectiveness of tofacitinib in older and younger patients with ulcerative colitis.
Post-marketing surveillance study in Japan.
Comparison of safety and effectiveness between patients aged ≥65 years and <65 years.
Safety outcomes included incidence rates of herpes zoster and serious infections.
Older patients had higher incidence rates of herpes zoster and serious infections compared to younger patients.
Effectiveness of tofacitinib was similar across both age groups.
Discontinuation due to adverse events was more common in older patients.

Implication

Post-marketing surveillance reveals higher risk of herpes zoster in older patients, indicating important safety considerations with tofacitinib.

Abstract

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.

Discussion

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Cite This Study

Matsuoka et al. (2025) studied this question.

synapsesocial.com/papers/69253a24c0ce034ddc357276 https://doi.org/10.5217/ir.2025.00058

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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

Key Points

Implication

Abstract

Discussion

Cite This Study

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

Key Points

Implication

Abstract

Discussion

Cite This Study

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