Infection risk in inflammatory bowel disease patients treated with vedolizumab: a systematic review and meta-analysis - Report - MDSpire

Infection risk in inflammatory bowel disease patients treated with vedolizumab: a systematic review and meta-analysis

  • By

  • Lidan Zhang

  • Xiaogang Hao

  • Yidan Cui

  • Wenjian Yan

  • Kun Shang

  • Xin Zhang

  • June 11, 2026

  • 0 min

Share

Clinical Report: Assessing Infection Risk in Patients with IBD Undergoing Vedolizumab Treatment

Overview

This systematic review and meta-analysis evaluated the infection risk associated with vedolizumab (VDZ) in patients with inflammatory bowel disease (IBD). The findings indicate a moderate overall infection incidence, primarily mild respiratory infections, with VDZ showing a comparable safety profile to TNF inhibitors and placebo but a higher risk compared to ustekinumab.

Background

Inflammatory bowel disease (IBD) encompasses chronic gastrointestinal inflammation, significantly impacting patient quality of life. Vedolizumab, a gut-selective monoclonal antibody, has emerged as a key treatment option for moderate-to-severe IBD. Understanding the infection risks associated with VDZ is crucial for optimizing patient management and therapeutic decision-making.

Data Highlights

OutcomePooled Incidence95% CI
Overall Infection Incidence13.08%9.85–17.18%
Respiratory Tract Infections4.25%N/A
VDZ vs TNF Inhibitors (RR)0.91N/A
VDZ vs Placebo (RR)1.02N/A
VDZ vs Ustekinumab (RR)1.63N/A

Key Findings

  • The overall pooled infection incidence in VDZ-treated patients was 13.08%.
  • Respiratory tract infections were the most common, accounting for 4.25% of cases.
  • No significant difference in infection risk was found between VDZ and TNF inhibitors (RR = 0.91).
  • VDZ showed a higher infection risk compared to ustekinumab (RR = 1.63).
  • Serious systemic and rare infections were infrequent among patients treated with VDZ.
  • Study design and geographic region were identified as significant moderators of infection risk.

Clinical Implications

Clinicians should be aware of the moderate infection risk associated with vedolizumab, particularly the prevalence of mild respiratory infections. Comparative risk assessments between VDZ and other therapies, such as ustekinumab, are essential for informed treatment decisions.

Conclusion

Vedolizumab presents a moderate infection risk profile, primarily involving mild respiratory infections, and its safety is comparable to TNF inhibitors and placebo, though inferior to ustekinumab.

Related Resources & Content

  1. Journal of Gastroenterology, 2018 -- Comprehensive Review and Meta-Analysis: Effectiveness and Safety of Vedolizumab in Real-World Patients with Inflammatory Bowel Disease
  2. Drugs - Real World Outcomes, 2023 -- Identifying Risk Factors for Pancreatitis in Inflammatory Bowel Disease Patients Receiving Vedolizumab: Insights from a Comprehensive Global Safety Database
  3. Real-World Evidence on the Subcutaneous Administration of Vedolizumab for Inflammatory Bowel Diseases: A Comprehensive Review
  4. The New Gastroenterologist, 2025 -- Choosing Treatment Options for Moderate to Severe Inflammatory Bowel Disease: Essential Considerations in the Decision-Making Process
  5. Living guideline for pharmacological management of moderate-to-severe ulcerative colitis - American Gastroenterological Association, 2024
  6. Vedolizumab as Induction and Maintenance Therapy for Ulcerative Colitis | New England Journal of Medicine
  7. Frontiers, 2026 -- Infection Risk in Inflammatory Bowel Disease Patients Treated with Vedolizumab: A Systematic Review and Meta-Analysis
  8. Living guideline for pharmacological management of moderate-to-severe ulcerative colitis - American Gastroenterological Association
  9. Vedolizumab as Induction and Maintenance Therapy for Ulcerative Colitis | New England Journal of Medicine
  10. Frontiers | Infection Risk in Inflammatory Bowel Disease Patients Treated with Vedolizumab: A Systematic Review and Meta-Analysis

Original Source(s)

Related Content