With vedolizumab approved for the treatment of ulcerative colitis (UC) in Canada (May 19, 2015 – ENTYVIO™), how effective and safe is it?
– Vedolizumab is effective and safe for the management of UC patients
– Its efficacy is less in those previously treated with anti-TNF agents
– Antibody development appears similar to other biologic agents
– No new safety signals were identified
Mosli MH, MacDonald JK, Bickston SJ, et al. Vedolizumab for induction and maintenance of remission in ulcerative colitis: a Cochrane systematic review and meta-analysis. Inflamm Bowel Dis. 2015 May;21(5):1151–9.
A total of 4 double-blind randomized placebo-controlled studies (606 patients with UC) were included in the meta-analysis of induction of clinical remission. A risk ratio (RR) of 0.86 in favour of vedolizumab over placebo for induction of clinical remission was identified.
This was based on an induction period of 4 to 6 weeks wherein 23% of the vedolizumab cohort achieved clinical remission versus 8% of the control cohort. More vedolizumab patients achieved clinical response (52%) than those taking placebo (28%) after 6 weeks of therapy (RR = 0.68 for vedolizumab).
Pooled data from two studies investigating UC and Crohn’s disease found that antidrug antibodies to vedolizumab were found in less frequently in patients receiving concomitant immunosuppressant therapy (3%) compared to those who were not (18%).
From two studies (n=941), the risk of serious adverse events with vedolizumab was similar to placebo (79% vs. 80%; RR = 1.00).
Study Design: Meta-analysis
Funding: None disclosed
Level of Evidence: 1a (Oxford Levels of Evidence)
The summary and conclusion in this issue of E-mentoring in IBD pertains to the manuscript(s) being reviewed, and should be considered in the context of what is already known surrounding the topic and incorporated into practice as deemed appropriate by the individual learner.