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Takeda's vedolizumab improves clinical remission in pivotal Crohn's disease trial

Friday, May 11 2012 | Comments
Evidence Grade 0 What's This?
Takeda Pharmaceutical Co. Ltd.'s vedolizumab significantly improves clinical remission when compared with placebo among patients with Crohn's disease (CD), according to data from a Phase III trial.

The GEMINI II study included 1,115 patients with moderately to severely active CD who had not responded adequately to at least one previous conventional therapy, including tumor necrosis factor-alpha antagonists. The trial participants received one year of treatment with vedolizumab, which is an alpha-4/beta-7 integrin antagonist, or placebo, starting with six weeks of induction therapy.

In both the induction and maintenance phases of the trial, vedolizumab reached the primary endpoint, providing statistically significant improvement in clinical remission as compared with placebo.

Vedolizumab also provided a numerically higher rate of enhanced clinical response, the other primary endpoint in the induction phase. However, the difference between active treatment and placebo with regard to this outcome was not statistically significant.

The most common adverse events reported in both the vedolizumab arm and the placebo arm were CD, joint pain, fever, upper respiratory inflammation, headache, nausea and abdominal pain.

Takeda said more detailed findings of the trial would be presented at an upcoming medical congress.

In February, the company reported that vedolizumab met the primary endpoints of the Phase III GEMINI I trial, in which the drug was evaluated as a treatment for moderately to severely active ulcerative colitis.

This information concerns a use that has not been approved by the Food and Drug Administration.

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