Department of Gastroenterology, Beijing Key Laboratory for Precancerous Lesion of Digestive Disease, Beijing Digestive Disease Center, Beijing Friendship Hospital, National Clinical Research Center for Digestive Disease, Capital Medical University, 95 Yong-an Road, Xi- cheng District, Beijing, China.
Institute of Clinical Medicine, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
BMC Gastroenterol. 2024 Oct 24;24(1):377. doi: 10.1186/s12876-024-03460-z.
Inflammatory bowel disease (IBD) is a chronic, relapsing condition wherein biologics have improved disease prognosis but introduced elevated infection susceptibility. Vedolizumab (VDZ) demonstrates unique safety advantages; however, a comprehensive systematic comparison regarding the risk of Clostridioides difficile infection (CDI) between vedolizumab and alternative medications remains absent.
Medline, Embase, Cochrane, and clinicaltrials.gov registry were comprehensively searched. Pooled estimates of CDI proportion, incidence, pooled risk ratio between ulcerative colitis (UC) and Crohn's disease (CD), vedolizumab and other medications were calculated. Data synthesis was completed in R using the package "meta".
Of the 338 studies initially identified, 30 met the inclusion/exclusion criteria. For CDI risk, the pooled proportion was 0.013 (95% CI 0.010-0.017), as well as the pooled proportion of serious CDI was 0.004 (95% CI 0.002-0.008). The comparative pooled risk ratios revealed: UC versus CD at 2.25 (95% CI 1.73-2.92), vedolizumab versus anti-TNF agents at 0.15 (95% CI 0.04-0.63) for UC and 1.29 (95% CI 0.41-4.04) for CD.
The overall CDI risk in IBD patients exposed to vedolizumab was estimated to be 0.013. An increased risk of CDI was noted in UC patients receiving vedolizumab compared to those with CD. Vedolizumab potentially offers an advantage over anti-TNF agents for UC regarding CDI risk, but not for CD.
The study was registered on the PROSPERO registry (CRD42023465986).
炎症性肠病（IBD）是一种慢性、复发性疾病，生物制剂改善了疾病预后，但增加了感染易感性。维得利珠单抗（VDZ）具有独特的安全性优势；然而，关于 VDZ 与其他药物相比发生艰难梭菌感染（CDI）的风险，目前仍缺乏全面的系统比较。
全面检索了 Medline、Embase、Cochrane 和 clinicaltrials.gov 注册数据库。计算了 CDI 比例、发生率、溃疡性结肠炎（UC）和克罗恩病（CD）之间的 pooled risk ratio、VDZ 与其他药物之间的 pooled risk ratio。使用 R 语言中的“meta”包完成数据综合。
最初确定的 338 项研究中，有 30 项符合纳入/排除标准。在 CDI 风险方面，pooled proportion 为 0.013（95% CI 0.010-0.017），严重 CDI 的 pooled proportion 为 0.004（95% CI 0.002-0.008）。比较 pooled risk ratio 发现：UC 与 CD 相比为 2.25（95% CI 1.73-2.92），UC 患者中 VDZ 与抗 TNF 药物相比为 0.15（95% CI 0.04-0.63），CD 患者中为 1.29（95% CI 0.41-4.04）。
暴露于 VDZ 的 IBD 患者的总体 CDI 风险估计为 0.013。与 CD 患者相比，接受 VDZ 治疗的 UC 患者 CDI 的风险增加。与抗 TNF 药物相比，VDZ 可能在 UC 患者的 CDI 风险方面具有优势，但在 CD 方面则不然。
该研究在 PROSPERO 注册库（CRD42023465986）注册。
