Comparative Efficacy and Rapidity of Action for Infliximab vs. Ustekinumab in Biologic Naive Crohn's Disease.

BACKGROUND AND AIMS Comparative effectiveness have become increasingly important to help position therapies for inflammatory bowel disease. We compared the efficacy and rapidity of onset of action of infliximab vs. ustekinumab induction therapy for moderate to severe biologic-naive Crohn's disease (CD) using patient-level data from randomized controlled trials. METHODS This was a post-hoc analysis of two large CD clinical trial programs which included data on 420 biologic-naive CD patients. Differences in proportions of patients achieving week 6 clinical remission (CR), clinical response, and normalization of calprotectin were compared. Multivariate logistic regression was used to adjust for confounders. Sensitivity analysis was conducted using propensity scores to create a cohort of matched participants with similar distribution of baseline co-variates. RESULTS At week 6, a comparable number of patients achieved CR with infliximab as compared to patients treated with ustekinumab (44.9% vs. 37.9%, aOR 1.22 (95%CI 0.79-1.89)). Similarly, at week 6 clinical response rates were not significantly different (58.4% infliximab vs. 54.9% ustekinumab, aOR 1.25 (95%CI 0.82-1.90)). No significant difference was observed between treatment groups for achieving week 6 fecal calprotectin <250 mcg/L in those with elevated values at baseline (42.3% infliximab vs. 34.7% ustekinumab, aOR 1.34 (95%CI 0.79-2.28)). Similar results were seen for all analyses done within the propensity matched cohort. CONCLUSIONS Based on this post-hoc analysis, infliximab and ustekinumab appear to have similar efficacy and speed of onset in patients with Crohn's disease who are biologic-naive.