Vedolizumab as the first line of biologic therapy for ulcerative colitis and Crohn's disease - a systematic review with meta-analysis

Dig Liver Dis. 2022 Sep;54(9):1168-1178. doi: 10.1016/j.dld.2021.11.014. Epub 2021 Dec 10.


Background: The efficacy and safety of vedolizumab in bio-naïve patients with ulcerative colitis (UC) and Crohn's disease (CD) remain unknown.

Aims: To perform a meta-analysis regarding vedolizumab as first line of biological therapy for UC or CD.

Methods: A systematic review of Medline, EMBASE, and Cochrane databases per December 2020 was undertaken. Meta-analysis was conducted using random-effects models.

Results: This systematic review identified 79 eligible studies with 4,520 and 3,494 bio-naïve patients with UC and CD, respectively, and 8,105 and 11,140 bio-exposed patients. Among bio-naïve patients with UC, a total of 40.0% (95%CI 27.0-54.0, I2=86%) and 63.9% (95%CI 47.0-79.2, I2=36%) achieved clinical remission at weeks 14 and 52, respectively. The corresponding rates in CD were 54.0% (95%CI 42.0-66.0, I2=23%), and 61.7% (95%CI 55.2-68.1, I2=0%). Bio-naïvety was associated with a higher probability of clinical remission at week 52 in UC (relative risk (RR)=1.32 (95%CI 1.14-1.53)), while this was only apparent until week 26 in CD (RR=1.60 (95%CI 1.30-1.95)). Finally, bio-naïve UC patients had a lower risk of serious adverse events (RR=0.29 (95%CI 0.09-0.95)).

Conclusion: Vedolizumab was found to have a favorable efficacy and safety profile in bio-naïve patients with UC and CD. The findings have implications in the management of IBD.

Keywords: Bio-naïve; First-line; Inflammatory bowel disease; Meta-analysis; Systematic review.

Publication types

  • Meta-Analysis
  • Review
  • Systematic Review

MeSH terms

  • Antibodies, Monoclonal, Humanized
  • Biological Therapy
  • Colitis, Ulcerative*
  • Crohn Disease*
  • Gastrointestinal Agents
  • Humans
  • Remission Induction
  • Treatment Outcome


  • Antibodies, Monoclonal, Humanized
  • Gastrointestinal Agents
  • vedolizumab