895, moderately to severely active UC despite treatment with at least one conventional therapy or an anti-TNFα biologic.
GEMINI I was a phase III randomised, double blind, placebo-controlled study of vedolizumab induction and maintenance treatment in patients with active ulcerative colitis (UC). This pivotal study was conducted between 2008 and 2012 and involved 895 patients.5
Study results showed that vedolizumab met primary endpoints of improvement in clinical response (reduction in the Mayo Clinic score of ≥3 points and ≥30% from baseline, along with a decrease of at least 1 point on the rectal bleeding subscale or an absolute rectal bleeding score of 0 or 1) at 6 weeks and clinical remission (Mayo score of 2 or lower and no subscore higher than 1) at 52 weeks.1
A significantly greater proportion of patients receiving vedolizumab achieved mucosal healing (Mayo endoscopic subscore of 0 or 1) at 6 and 52 weeks, and steroid remission at 52 weeks, both secondary endpoints, as compared with placebo.1
In addition, a greater proportion of patients in the groups treated with vedolizumab maintained clinical response and demonstrated durable clinical remission, both secondary endpoints of the study.1