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Positive Results Reported for Vedolizumab in GI Disorders
Pivotal studies evaluate treatment of ulcerative colitis and Crohn’s disease (August 22)
Positive results have been reported from two phase 3 studies evaluating vedolizumab (Millennium Pharmaceuticals/Takeda), an investigational humanized monoclonal antibody, for the treatment of adults with moderately to severely active ulcerative colitis (UC) and Crohn’s disease (CD). The new findings were published in the Aug. 22 issue of the New England Journal of Medicine.
Vedolizumab is designed to antagonize the alpha4beta7 integrin, which is expressed on a subset of circulating white blood cells that have been shown to play a role in mediating the inflammatory process in CD and UC.
In the GEMINI I trial — a phase 3 placebo-controlled induction and maintenance study — the intent-to-treat (ITT) population comprised 374 patients with UC, with an additional 521 patients receiving open-label vedolizumab.
The results showed that vedolizumab met primary endpoints of improvement in the clinical response (i.e., a reduction in the Mayo Clinic score of ≥ 3 points and ≥ 30 percent 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 (a Mayo score of 2 or lower and no subscore higher than 1) at 52 weeks. In addition, a significantly greater proportion of patients receiving vedolizumab achieved mucosal healing (Mayo endoscopic subscore of 0 or 1) at 6 and 52 weeks, and glucocorticoid-free remission at 52 weeks, compared with placebo.
The GEMINI II trial was a phase 3, randomized, parallel-group, double-blind, placebo-controlled induction and maintenance study designed to assess the efficacy and safety of vedolizumab in adults with moderately to severely active CD in whom one prior therapy had failed.
Vedolizumab demonstrated statistically significant improvement in the primary endpoint of clinical remission (Crohn’s Disease Activity Index [CDAI] score ≤ 150 points) at 6 and 52 weeks compared with placebo. At 6 weeks, no significant difference was observed in the co-primary endpoint of the CDAI-100 response (≥ 100-point decrease in the CDAI score) between the vedolizumab and placebo groups. A significantly greater proportion of patients showed a CDAI-100 response and glucocorticoid-free remission at 52 weeks.
Source: Takeda; August 22, 2013.