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Original Article
- IBD
- Tuberculosis risk in patients with Crohn’s disease on biologics: a retrospective analysis of the Japanese Medical Claims Database
- Koji Fujimoto, Shuhei Hosomi, Yumie Kobayashi, Rieko Nakata, Yu Nishida, Masaki Ominami, Yuji Nadatani, Shusei Fukunaga, Koji Otani, Fumio Tanaka, Satoko Ohfuji, Yasuhiro Fujiwara
- Intest Res 2025;23(3):309-317. Published online August 19, 2024
- DOI: https://doi.org/10.5217/ir.2024.00076
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Abstract
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Supplementary Material
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ePub - Background/Aims
Treatment using tumor necrosis factor-α (TNF-α) inhibitors is one of the risk factors for active tuberculosis (TB) in patients with Crohn’s disease (CD). Biologics, such as ustekinumab (UST) and vedolizumab (VDZ), are less likely to cause opportunistic infections. However, large-scale studies for active TB and biologics other than TNF-α inhibitors are limited. We aimed to investigate the association between biologics and active TB utilizing a Japanese medical claims database.
Methods
We analyzed retrospectively the association of the risk of active TB development with treatment using TNF-α inhibitors and other biologics (UST and VDZ) in patients with CD using the Japanese Medical Data Vision (MDV) database between April 2008 and June 2022. The durations of each biologic and biologic-free treatment were calculated for each patient. Univariate and multivariate analyses were performed using the Cox proportional hazards model, with the utilization of biologics considered as time-dependent covariates.
Results
We included 28,811 patients with CD in MDV database. Finally, 17,169 patients were analyzed. In total, 7,064 patients were categorized as biologic-naïve, while 10,105 were classified as biologic-experienced. Seventeen patients developed active TB, including 7 on infliximab, 5 on adalimumab, and 5 on no biologics. None of the patients treated with UST and VDZ developed active TB. Multivariate analysis suggested that TNF-α inhibitors were the risk factors for active TB (hazard ratio, 3.66; P= 0.020).
Conclusions
TNF-α inhibitors, but not UST or VDZ, are risk factors for active TB in Japanese patients with CD. -
Citations
Citations to this article as recorded by
- Research Communication: Risk of Tuberculosis With Advanced Therapies in 20,705 Patients With Inflammatory Bowel Diseases in Low Incidence Regions—A U.S. Claims‐Based Study
Dhruv Ahuja, Kuan‐Hung Yeh, Sagar B. Patel, Soo‐kyung Park, Ronghui Xu, Siddharth Singh
Alimentary Pharmacology & Therapeutics.2026; 63(6): 885. CrossRef - Prevalence and clinical impact of latent tuberculosis infection in patients with inflammatory bowel disease in Japan: a retrospective multicenter study by the IBD-Quality team
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June Hwa Bae, Seung Yong Shin, Dong Hyun Kim, Seung Min Hong, Eun Mi Song, Ji Eun Kim, Young Joo Yang, Jiyoung Yoon, Sang-Bum Kang, Eun Soo Kim, Sung Eun Kim, Seong-Jung Kim, Jun Lee, Soo-Young Na, Soo Jung Park, Sang Hyoung Park, Won Moon, Sung-Ae Jung
Intestinal Research.2025; 23(4): 491. CrossRef - Safety assessment of ustekinumab in inflammatory bowel disease: a real-world analysis based on the FDA adverse event reporting system (FAERS)
Likang Xu, Zhenkai Huang, Gong Chen, Chao Sun, Yang Yu, Sujun Gao
European Journal of Medical Research.2025;[Epub] CrossRef
- Research Communication: Risk of Tuberculosis With Advanced Therapies in 20,705 Patients With Inflammatory Bowel Diseases in Low Incidence Regions—A U.S. Claims‐Based Study
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