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.
Key findings:
- 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
Limitations:
- 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
Related posts:
Adalibumab still isn’t FDA approved fro UC in under 18 year old age group, so insurance companies often make it more difficult to approve. Therefore, more infiximab use in the UC under 18 year old population.
That’s definitely true. Also, many experts have indicated a preference for infliximab over adalimumab (among anti-TNF treatments) in ulcerative colitis.