Data show the prescription drug Entyvio, which is used to treat irritable bowel disease, is as effective as lab-controlled studies suggested before its United States release in 2014
Maker Takeda Pharmaceutical Co. recently announced its research findings in Chicago during the Digestive Disease Week meeting in Chicago.
Two studies are relevant: the original GEMINI Phase III program that cleared Entyvio for use in 2014 and the new Vedolizumabfor health Outcomes in Inflammatory Bowel Disease (VICTORY) Consortium, which echoes the earlier study’s proof of the drug’s efficacy.
The VICTORY data include outcomes from 180 patients with moderate to severe forms of the diseases, according to a Takeda press release. Over a one-year period, Entyvio healed tissues and stalled the diseases’ development without steroids.
The findings were hailed as a boon for sufferers of ulcerative colitis and Crohn’s disease, two specific conditions targeted by Entyvio, the release said.
Dr. William Sandborn, a University of California at San Diego professor of gastroenterology, said the consortium provides "valuable" clinical information.
“Real-world evidence plays an important role in helping health care providers evaluate a therapy’s effectiveness and safety in routine medical practice against clinical trial results, and the VICTORY consortium provides valuable clinical knowledge for the IBD community,” Sandborn said.
The Centers for Disease Control’s Crohn’s and Colitis Foundation says the diseases together affect more than 1.5 million in the United States.