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Meta-Analysis
. 2024 Oct 24;24(1):377.
doi: 10.1186/s12876-024-03460-z.

Risk of Clostridioides difficile infection in inflammatory bowel disease patients undergoing vedolizumab treatment: a systematic review and meta-analysis

Wei Chen #  1 , Yuhang Liu #  1 , Yuelun Zhang  2 , Hong Zhang  3 , Chuyan Chen  1 , Siying Zhu  1 , Yanhua Zhou  1 , Haiying Zhao  1 , Ye Zong  4
Affiliations
Meta-Analysis

Risk of Clostridioides difficile infection in inflammatory bowel disease patients undergoing vedolizumab treatment: a systematic review and meta-analysis

Wei Chen et al. BMC Gastroenterol. .

Abstract

Background: 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.

Method: 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".

Results: 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.

Conclusion: 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.

Trial registration: The study was registered on the PROSPERO registry (CRD42023465986).

Keywords: Clostridioides difficile infection; Inflammatory bowel disease; Systematic review; Vedolizumab.

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Conflict of interest statement

The authors declare no competing interests.

Figures

Fig. 1
Fig. 1
PRISMA flow diagram showing the flow and final inclusion of studies
Fig. 2
Fig. 2
Risk of Clostridioides difficile infection (CDI) in inflammatory bowel disease (IBD) patients in treatment of vedolizumab. A Pooled proportion of CDI for all included studies; B Pooled proportion of serious CDI; C Pooled rate of CDI for studies with follow-up endpoint of CDI; D Pooled rate of serious CDI
Fig. 3
Fig. 3
Comparison of Clostridioides difficile infection (CDI) risk between ulcerative colitis (UC) and Crohn’s disease (CD). A Pooled proportion of CDI between UC and CD according to subgroup analysis, P = 0.10. B Risk Ratio of CDI between UC and CD from 6 eligible cohort studies
Fig. 4
Fig. 4
Comparison of Clostridioides difficile infection (CDI) risk in inflammatory bowel disease (IBD) patients in treatment of vedolizumab and other drugs. A Pooled risk ratio of CDI risk between vedolizumab and anti-TNF from 8 eligible studies; B Pooled risk ratio of serious CDI risk between vedolizumab and anti-TNF from 2 eligible studies; C Pooled risk ratio of CDI risk between vedolizumab and 5-ASA from 2 eligible studies
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