To evaluate the infection risk associated with vedolizumab (VDZ) in patients with inflammatory bowel disease and to compare its safety with tumor necrosis factor inhibitors, ustekinumab, and placebo.
Approach:
Key Findings:
Overall pooled infection incidence was 13.08% (95% CI: 9.85–17.18%), with respiratory tract infections being the most common (4.25%).
Serious systemic and rare infections were infrequent.
No significant difference in infection risk was observed between VDZ and TNF inhibitors (RR = 0.91) or placebo (RR = 1.02).
VDZ was associated with a significantly higher risk compared with ustekinumab (RR = 1.63).
Meta-regression identified study design and geographic region as significant moderators.
Interpretation:
Limitations:
Extreme heterogeneity limits the clinical utility of pooled incidence estimates.
Variations in study design, sample size, and definitions of infectious events may affect results.