A previous blog post (Vedolizumab More Effective Than Adalimumb for Ulcerative Colitis) highlighted a preliminary report on the “VARSITY” study. The full report has now been published (BE Sands et al NEJM 2019; 381: 1215-26) and a little nuance is needed.
This double-blind, double-dummy randomized trial included 769 patients who underwent randomization to receive at least one dose of one of the study medications.
- At week 52, clinical remission was higher in the vedolizumab group: 31.3% compared to 22.5% for adalimumab
- Endoscopic improvement was better for vedolizumab: 39.7% compared to 27.7%
- Corticosteroid-free remission was better for adalimumab: 21.8% compared to 12.6% for vedolizumab
- dose escalation was not allowed during the study –this limitation likely favors vedolizumab compared to adalimumab
- previous exposure to an anti-TNF agent was allowed in up to 25% of patients
My take: In two of three key measures, vedolizumab outperformed adalimumab. This study provides a rationale for vedolizumab to be considered a first-line agent. That being said, in my clinical experience, infliximab is a much more frequently used anti-TNF agent in moderate-to-severe ulcerative colitis. So a head-to-head study with infliximab would be of interest.
The image below shows histologic remission differences at week 52