Dr Brian Feagan and colleagues conducted 2 integrated randomized, double-blind, placebo-controlled trials of vedolizumab in patients with active disease.
In the trial of induction therapy, 374 patients received vedolizumab (at a dose of 300 mg) or placebo intravenously at weeks 0 and 2, and 521 patients received open-label vedolizumab at weeks 0 and 2, with disease evaluation at week 6.
In the trial of maintenance therapy, patients in either cohort who had a response to vedolizumab at week 6 were randomly assigned to continue receiving vedolizumab every 8 or 4 weeks or to switch to placebo for up to 52 weeks.
A response was defined as a reduction in the Mayo Clinic score of at least 3 points, and a decrease of at least 30% from baseline, with an accompanying decrease in the rectal bleeding subscore of at least 1 point or an absolute rectal bleeding subscore of 0 or 1.
The team noted that response rates at week 6 were 47% and 26% among patients in the vedolizumab group and placebo group, respectively.
|Response rates at week 6 were 47% among patients in the vedolizumab group |
|New England Journal of Medicine|
At week 52, the team observed that 42% of patients who continued to receive vedolizumab every 8 weeks, and 45% of patients who continued to receive vedolizumab every 4 weeks were in clinical remission.
In comparison, the researchers noted that 16% of patients who switched to placebo, and 29% points for vedolizumab every 4 weeks vs. placebo.
The researchers found that the frequency of adverse events was similar in the vedolizumab and placebo groups.
Dr Feagan's team concludes, "Vedolizumab was more effective than placebo as induction and maintenance therapy for ulcerative colitis."