Hospitalized Infection Risk and Organ-specific Infection Patterns Across Advanced Therapies in Ulcerative Colitis: A Japanese Claims Analysis
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.
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BibTeX
@article{nishida2026hospitalized,
title = {{Hospitalized Infection Risk and Organ-specific Infection Patterns Across Advanced Therapies in Ulcerative Colitis: A Japanese Claims Analysis}},
author = {Yu Nishida and Shuhei Hosomi and Rieko Nakata and Hirotsugu Maruyama and Masaki Ominami and Yuji Nadatani and Shusei Fukunaga and Koji Otani and Yasuhiro Fujiwara},
journal = {Internal Medicine},
year = {2026},
month = oct,
doi = {10.2169/internalmedicine.7882-26},
url = {https://www.jstage.jst.go.jp/article/internalmedicine/advpub/0/advpub_7882-26/_article},
note = {CC BY-NC-ND},
}
RIS
TY - JOUR
TI - Hospitalized Infection Risk and Organ-specific Infection Patterns Across Advanced Therapies in Ulcerative Colitis: A Japanese Claims Analysis
AU - Yu Nishida
AU - Shuhei Hosomi
AU - Rieko Nakata
AU - Hirotsugu Maruyama
AU - Masaki Ominami
AU - Yuji Nadatani
AU - Shusei Fukunaga
AU - Koji Otani
AU - Yasuhiro Fujiwara
PY - 2026
DA - 2026/10/08
JO - Internal Medicine
DO - 10.2169/internalmedicine.7882-26
UR - https://www.jstage.jst.go.jp/article/internalmedicine/advpub/0/advpub_7882-26/_article
AB - 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.
SN - 1349-7235
SN - 0918-2918
ER -