Comparative Efficacy for Infliximab Vs Vedolizumab in Biologic Naive Ulcerative Colitis

Abstract

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. 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. 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. 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.