Vedolizumab and Adalimumab in Biologic-Naive Ulcerative Colitis: Comparison of Patient-Level Clinical Trial Data and VARSITY for Week 6 Clinical Remission

BackgroundIndirect treatment comparisons using patient-level data are increasing in popularity within inflammatory bowel disease research. We compared the efficacy of adalimumab and vedolizumab for biologic-naive moderate-severe ulcerative colitis (UC) using indirect comparisons of phase 3 clinical trials and compared the results to the RCT VARSITY.DesignPooled analysis of patient-level data from 518 biologic-naive patients with UC was performed using GEMINI-1 and ULTRA-1. Proportions of patients achieving week 6 clinical remission and clinical response were compared, and propensity score matching and multivariate logistic regression were used to account for potential confounders. These results were compared to those derived from VARSITY.ResultsA numerically greater proportion of vedolizumab-treated patients from GEMINI-1 achieved week 6 clinical remission compared to those treated with adalimumab [136/388 (35.1%) vs. 38/130 (29.2%)]. Similar findings were observed among the propensity score matched cohort [33/110 (30.0%) vs. 25/110 (22.7%), adjusted OR (aOR) 1.56 (95% confidence interval (CI) 0.81-3.02), p = 0.187]. A similar magnitude for absolute difference in the proportions of patients achieving week 6 clinical remission was observed from VARSITY in vedolizumab compared to adalimumab [131/305 (43.0%) vs. 114/307 (37.1%), OR 1.27 (95% CI 0.92-1.76), p = 0.142].ConclusionsIn this post hoc analysis, a similar magnitude in the absolute difference of efficacy at week 6 among biologic-naive patients was observed using indirect comparisons of phase 3 clinical trial data as was observed in VARSITY. Indirect comparisons using patient-level clinical trial data could be used to inform drug choices for future head-to-head trials and guide positioning of drugs in the absence of head-to-head trials.

Automated summary

This study compared the efficacy of adalimumab and vedolizumab for biologic-naive moderate-severe ulcerative colitis using indirect comparisons of phase 3 clinical trials. The results showed that vedolizumab had a better efficacy at week 6 compared to adalimumab. This suggests that indirect comparisons using patient-level clinical trial data can be used to guide future head-to-head trials and drug positioning in the absence of direct comparisons.