Issue 13

Clinical Question

What is the efficacy of vedolizumab in patients with Crohn’s disease (CD)?

Editor’s Bottom Line

Vedolizumab is effective for the treatment of Crohn’s disease in both TNF exposed and TNF naïve patients.

Editorial Note

Although the efficacy of vedolizumab in this study with Crohn’s disease patients was slightly less than that seen in patients with ulcerative colitis, it is nonetheless effective. We are anticipating Health Canada approval of vedolizumab for the treatment of Crohn’s disease in near future.

Reference

Sands BE, Feagan BG, Rutgeerts P, et al. Effects of vedolizumab induction therapy for patients with Crohn’s disease in whom tumor necrosis factor antagonist treatment failed. Gastroenterology. 2014 Sep;147(3):618–627.
https://www.ncbi.nlm.nih.gov/pubmed/24859203

Synopsis

Patients with moderate-to-severe CD who had loss of response, intolerance or inadequate response to anti-TNFs, steroids, or immunosuppressives. Patients were grouped according to prior anti-TNF use, or naïve to anti-TNF use, and randomized 1:1 to receive either vedolizumab study drug (300 mg) or placebo at weeks 0, 2, and 6.

The primary study endpoint compared the clinical remission rates at week 6 and week 10.

Secondary endpoints examined clinical response at week 6 and week 10.

Prior TNF Population:

Remission

Week 6: Vedolizumab 15% vs placebo 12%; P=.433

Week 10: Vedolizumab 27% vs placebo 12%; P=.001

Response

Week 6: Vedolizumab 40% vs placebo 22%; P=.001

Week 10: Vedolizumab 47% vs placebo 24%; P=.001

Naïve TNF Population:

Remission

Week 6: Vedolizumab 31% vs placebo 12%; P=.012

Week 10: Vedolizumab 35% vs placebo 16%; P=.025

Response

Week 6: Vedolizumab 39% vs placebo 24%; P=.088

Week 10: Vedolizumab 51% vs placebo 22%; P=.002

There were no new safety signals.

Details

Study Design: Randomized controlled trial
Funding: Millennium Pharmaceuticals, Inc. as Takeda Pharmaceuticals International Co.
Allocation: Stratified block randomization (8 strata and 16 blocks)
Setting: 107 sites in North America, Europe, Asia, Africa, and Australia
Level of Evidence: 1b (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.