The primary end point of the maintenance phase was clinical remission at 52 weeks, defined as a total Mayo score of 2 or less and no subscore greater than 1 point. This end point was met by 45% of patients who received vedolizumab every 4 weeks, by 42% who received the drug every 8 weeks, and by 16% of the placebo patients. Clinical remission without corticosteroid treatment occurred in 45% of patients who got vedolizumab every 4 weeks, 31% who got the drug every 8 weeks, and 14% who took placebo. Among patients with a history of anti-TNF treatment, clinical remission after 1 year occurred in 35% of patients maintained with the drug every 4 weeks, 37% who got the drug every 8 weeks, and 5% who took placebo. A total of 209 patients remained in the study through the 52-week assessment.
On May 11, Millennium Pharmaceuticals, the company developing vedolizumab, announced that the drug significantly surpassed placebo for the treatment of Crohn’s disease in the pivotal, phase III trial for that indication. The company said that it will soon report the full Crohn’s disease results.
The GEMINI I study was funded by Millennium. Dr. Feagan said he has been a consultant to Millennium and to several other drug companies. Dr. Sandborn said he has been a consultant to several drug companies but has no relationship with Millennium.
