The study specifically examined the question of how well vedolizumab in patients with Crohn's disease who have already been on a different type of anti-TNF agent. The trial enrolled over 400 patients and 3/4 of the patients had to have previously failed one anti-TNF agent. About half of the patients enrolled failed two anti-TNF agents and a small percentage failed all three anti-TNF agents. The primary end point of the clinical trial was looking at the clinical remission rate at week six. Clinical remission was defined as a Crohn's disease activity index of 150 or less.
The patients in the trial received the drug at weeks 0, 2, and 6, and were followed until week 10.
The primary end point of the clinical trial was not met. About 15% of patients receiving vedolizumab and 12% receiving the placebo met the primary end point, and the results weren't significantly significant. However, at week 10, the remission rates were significantly different; the placebo rate stayed the same and the vedolizumab remission rate went up significantly.
The message from this study is that vedolizumab does work in patients that have failed other anti-TNF agents with significant difference showing up after week 10.
Read the full study online here.
For more information about IBD, visit mayoclinic.org/ibd.
Dr. Loftus is a gastroenterologist at Mayo Clinic.