Risk factors and clinical characteristics of Clostridium difficile colonization and infection in patients with inflammatory bowel disease exposed to Vedolizumab: a multicenter retrospective study.
Qing Li, Xiaomei Song, Peizhu Su, Xiaoping Lv, Xinyu Liu, Xuemin Chen, Jian Tang, Xiang Gao, Kang Chao
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引用次数: 0
Abstract
Background: Vedolizumab (VDZ), a humanized monoclonal antibody that selectively inhibits the binding of the α4β7 integrin, has been approved for treating inflammatory bowel disease (IBD). Long-term safety studies of VDZ in clinical trials identified Clostridium difficile infection (CDI) as the major opportunistic infection.
Objectives: We aimed to address the incidence and risk factors of C. difficile colonization (CDC) and CDI in a real-world setting among IBD patients treated with VDZ.
Design: Retrospective multicenter study.
Methods: We retrospectively included IBD patients who tested negative for C. difficile before initiating standard VDZ therapy at four tertiary hospitals from November 1, 2021, to November 31, 2023. The primary outcome was the occurrence of CDC after VDZ initiation, and the secondary outcome was the occurrence of CDI and severe CDI.
Results: A total of 454 patients were included in the final analysis. The median follow-up time was 12.9 (8.2-16.3) months, and the study was followed for 2488.6 person-months. The CDC occurred in 28 patients (6.2%), including 23 (11.4%) patients with ulcerative colitis (UC; 18 asymptomatic carriers and 5 with symptomatic CDI) and 5 (2.0%) patients with Crohn's disease (asymptomatic carriers). Multivariate analysis showed that age >40 years old and UC were independent risk factors for the occurrence of the CDC after VDZ initiation. The incidence of CDI was 1.1%, and all patients were able to continue VDZ therapy after receiving antibiotic treatment. No risk factors were found to be significantly associated with CDI. There were no cases of severe CDI or deaths within 30 days.
Conclusion: The incidence of CDC after VDZ treatment was 6.2% and the majority of patients identified as asymptomatic carriers and were able to continue VDZ treatment. Age (>40 years old) and UC were the risk factors for CDC.
期刊介绍：
Therapeutic Advances in Gastroenterology is an open access journal which delivers the highest quality peer-reviewed original research articles, reviews, and scholarly comment on pioneering efforts and innovative studies in the medical treatment of gastrointestinal and hepatic disorders. The journal has a strong clinical and pharmacological focus and is aimed at an international audience of clinicians and researchers in gastroenterology and related disciplines, providing an online forum for rapid dissemination of recent research and perspectives in this area.
The editors welcome original research articles across all areas of gastroenterology and hepatology.
The journal publishes original research articles and review articles primarily. Original research manuscripts may include laboratory, animal or human/clinical studies – all phases. Letters to the Editor and Case Reports will also be considered.
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