Tuberculosis risk in patients with Crohn's disease on biologics: a retrospective analysis of the Japanese Medical Claims Database.

IF 3.4 Q2 GASTROENTEROLOGY & HEPATOLOGY

Intestinal Research Pub Date : 2024-08-19 DOI:10.5217/ir.2024.00076

Koji Fujimoto, Shuhei Hosomi, Yumie Kobayashi, Rieko Nakata, Yu Nishida, Masaki Ominami, Yuji Nadatani, Shusei Fukunaga, Koji Otani, Fumio Tanaka, Satoko Ohfuji, Yasuhiro Fujiwara

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引用次数: 0

Abstract

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.

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使用生物制剂的克罗恩病患者患结核病的风险：对日本医疗索赔数据库的回顾性分析。

背景/目的：使用肿瘤坏死因子-α（TNF-α）抑制剂进行治疗是克罗恩病患者患活动性结核病（TB）的风险因素之一。生物制剂，如乌司他单抗（UST）和维妥珠单抗（VDZ），不太可能引起机会性感染。然而，针对活动性肺结核和 TNF-α 抑制剂以外的生物制剂的大规模研究非常有限。我们旨在利用日本医疗索赔数据库调查生物制剂与活动性肺结核之间的关联：我们利用日本医疗数据视野（MDV）数据库，回顾性分析了2008年4月至2022年6月期间CD患者使用TNF-α抑制剂和其他生物制剂（UST和VDZ）治疗与活动性肺结核发病风险之间的关联。计算了每位患者接受每种生物制剂和无生物制剂治疗的时间。使用Cox比例危险模型进行单变量和多变量分析，并将使用生物制剂作为时间依赖性协变量：我们在MDV数据库中收录了28811名CD患者。最后，对17169名患者进行了分析。共有7064名患者被归类为生物制剂无效患者，10105名患者被归类为生物制剂使用经验不足患者。17名患者出现活动性肺结核，其中7人使用英夫利西单抗，5人使用阿达木单抗，5人未使用生物制剂。接受UST和VDZ治疗的患者中没有一人出现活动性结核。多变量分析表明，TNF-α抑制剂是活动性结核病的危险因素（危险比为3.66；P= 0.020）：结论：TNF-α抑制剂（而非UST或VDZ）是日本CD患者罹患活动性肺结核的危险因素。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Intestinal Research GASTROENTEROLOGY & HEPATOLOGY-

CiteScore

7.40

自引率

10.20%

发文量

审稿时长

38 weeks

期刊介绍： Intestinal Research (Intest Res) is the joint official publication of the Asian Organization for Crohn''s and Colitis (AOCC), Chinese Society of IBD (CSIBD), Japanese Society for IBD (JSIBD), Korean Association for the Study of Intestinal Diseases (KASID), Taiwan Society of IBD (TSIBD) and Colitis Crohn''s Foundation (India) (CCF, india). The aim of the Journal is to provide broad and in-depth analysis of intestinal diseases, especially inflammatory bowel disease, which shows increasing tendency and significance. As a Journal specialized in clinical and translational research in gastroenterology, it encompasses multiple aspects of diseases originated from the small and large intestines. The Journal also seeks to propagate and exchange useful innovations, both in ideas and in practice, within the research community. As a mode of scholarly communication, it encourages scientific investigation through the rigorous peer-review system and constitutes a qualified and continual platform for sharing studies of researchers and practitioners. Specifically, the Journal presents up-to-date coverage of medical researches on the physiology, epidemiology, pathophysiology, clinical presentations, and therapeutic interventions of the intestinal diseases. General topics of interest include inflammatory bowel disease, colon and small intestine cancer or polyp, endoscopy, irritable bowel syndrome and other motility disorders, infectious enterocolitis, intestinal tuberculosis, and so forth. The Journal publishes diverse types of academic materials such as editorials, clinical and basic reviews, original articles, case reports, letters to the editor, brief communications, perspective, statement or commentary, and images that are useful to clinicians and researchers.