Comparative Efficacy for Infliximab Vs Vedolizumab in Biologic Naive Ulcerative Colitis

Clin Gastroenterol Hepatol. 2022 Jul;20(7):1588-1597.e3. doi: 10.1016/j.cgh.2021.07.038. Epub 2021 Jul 28.


Background & aims: Comparative effectiveness studies are needed to help position therapies for ulcerative colitis (UC). We compared the efficacy of infliximab vs vedolizumab for moderate to severe biologic-naïve UC using patient-level data from clinical trial program data sets.

Methods: This was a post hoc analysis of 3 UC clinical trial programs that included data on 795 biologic-naïve UC patients. Differences in proportions of patients achieving week 6 clinical remission (CR) and response, and 1-year CR, corticosteroid-free CR, and endoscopic remission (ER), are reported. Multivariate logistic regression was used to adjust for potential confounders. As a sensitivity analysis, propensity scores were calculated and a cohort of matched participants with similar distribution of baseline covariates was created. All analyses were intention-to-treat.

Results: At week 6, comparable proportions of patients achieved clinical response and CR with infliximab vs vedolizumab (clinical response, 60.5% [138 of 228] vs 60.0% [340 of 567]; P = .884; and CR, 39.9% [91 of 228] vs 38.6% [219 of 567]; P = .736). Similar proportions of patients achieved 1-year CR with infliximab vs vedolizumab (39.9% [91 of 228] vs 38.6% [219 of 567]; adjusted odds ratio [aOR], 1.02; 95% CI, 0.74-1.40). Infliximab-treated patients had significantly higher rates of 1-year ER (36.0% [82 of 228] vs 25.6% [145 of 567]; aOR, 1.60; 95% CI, 1.12-2.28) and corticosteroid-free CR (29.5% [23 of 78] vs 15.0% [38 of 254]; aOR, 2.36; 95% CI, 1.27-4.39). Similar results were observed in the propensity score matched cohort.

Conclusions: Although infliximab and vedolizumab have similar efficacy in clinical symptom improvement, infliximab had higher rates of 1-year corticosteroid-free CR and ER in treatment of biologic-naïve UC.

Keywords: Inflammatory Bowel Disease; Infliximab; Ulcerative Colitis; Vedolizumab.

Publication types

  • Research Support, N.I.H., Extramural
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adrenal Cortex Hormones / therapeutic use
  • Antibodies, Monoclonal, Humanized / therapeutic use
  • Biological Products* / therapeutic use
  • Colitis, Ulcerative* / drug therapy
  • Gastrointestinal Agents / therapeutic use
  • Humans
  • Infliximab / therapeutic use
  • Treatment Outcome


  • Adrenal Cortex Hormones
  • Antibodies, Monoclonal, Humanized
  • Biological Products
  • Gastrointestinal Agents
  • vedolizumab
  • Infliximab