Takeda Pharmaceutical has announced top-line results from the international, randomized, placebo-controlled, double-blind GEMINI II pivotal phase 3 trial.
The trial has evaluated Vedolizumab in 1,115 patients with moderately to severely active Crohn's disease who have failed at least one conventional therapy, including TNF-alpha antagonists. Many of the patients included in the study had failed two or more TNF-alpha antagonists.
Patients received a year of Vedolizumab ( Entyvio ) or placebo treatment, starting with 6 weeks of induction therapy.
In both phases of the trial, induction and maintenance, Vedolizumab demonstrated statistically significant improvement in the primary endpoint of clinical remission compared to placebo.
Additionally, Vedolizumab provided a numerically higher rate of enhanced response, the other primary end point in the induction phase, although not statistically significant.
The most common adverse events ( greater than 10% ) reported in both the Vedolizumab arm and the placebo arm were: Crohn's disease, arthralgia, pyrexia, nasopharyngitis, headache, nausea, and abdominal pain.
Vedolizumab is an investigational humanized monoclonal antibody against a4B7 integrin, which is expressed on a subset of circulating white blood cells. These cells have been shown to play a role in mediating the inflammatory process in ulcerative colitis and Crohn's disease.
Crohn's disease is an inflammatory bowel disease ( IBD ). It causes inflammation of the lining of the digestive tract, which can lead to abdominal pain, severe diarrhea and malnutrition. Inflammation caused by Crohn's disease can involve different areas of the digestive tract in different people. Crohn's disease can be both painful and debilitating, and sometimes may lead to life-threatening complications. ( Xagena )
Source: Takeda, 2012