Hospitalized Infection Risk and Organ-specific Infection Patterns Across Advanced Therapies in Ulcerative Colitis: A Japanese Claims Analysis.

Authors

Yu Nishida, Shuhei Hosomi, Rieko Nakata, Hirotsugu Maruyama, Masaki Ominami, Yuji Nadatani, Shusei Fukunaga, Koji Otani, Yasuhiro Fujiwara

Published in

Internal medicine (Tokyo, Japan). Oct 08, 2026. Epub Oct 08, 2026.

Abstract

Background　Evidence comparing infections across advanced therapies (ADTs) for ulcerative colitis (UC) remains inconsistent, and infection category profiles are poorly characterized, particularly in real-world Japanese settings. We compared the risk of hospitalized infections and descriptively characterized the distribution of infection categories among hospitalized infection events across ADTs.Methods　We conducted a retrospective cohort study using the Medical Data Vision Database. Patients with UC who initiated treatment with a tumor necrosis factor (TNF) antagonist, ustekinumab, tofacitinib, or vedolizumab between April 2008 and May 2022 were followed. Adjusted hazard ratios (aHRs) were estimated using Cox models (TNF antagonists as the reference), and hospitalized infections were classified according to the organ system.Results　We included 9,012 patients receiving ADTs (TNF antagonists, 3,990; ustekinumab, 1,380; tofacitinib, 1,183; and vedolizumab, 2,459). Hospitalized infections occurred in 90, 16, 21, and 52 patients prescribed TNF antagonists, ustekinumab, tofacitinib, and vedolizumab, respectively; the incidence rates per 1,000 person-years were 19.09, 9.64, 14.53, and 17.24, respectively. In the multivariable analysis, ustekinumab was associated with a lower risk of hospitalized infection than TNF antagonists (aHR 0.46, 95% confidence interval [CI] 0.25-0.82), whereas tofacitinib (aHR 0.73, 95% CI 0.43-1.22) and vedolizumab (aHR 0.76, 95% CI 0.53-1.10) were not significantly different. Among the first hospitalized infection events, the distribution of infection categories was comparable across ADTs, with respiratory infections being the most common.Conclusions　Ustekinumab was associated with a lower risk of infection-related hospitalization than TNF antagonists. The distribution of infection categories among the first hospitalized infection events was comparable across the ADTs. These findings provide the first large-scale, real-world, comparative evidence from Japan.

PMID:
42844189
Bibliographic data and abstract were imported from PubMed on 08 Oct 2026.

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