Recently compiled safety data from all clinical trials on Entyvio (vedolizumab) for patients with inflammatory bowel disease (IBD) show the drug is associated with low rates of new serious infections, infusion-related reactions, and cancers.
The review of Entyvio's safety data, published in the journal Gut, is the most comprehensive analysis of six clinical trials. The study was performed by Jean-Frédéric Colombel, director of the Susan and Leonard Feinstein IBD Clinical Center at Mount Sinai in New York."Entyvio is a monoclonal antibody that targets the [alpha-4/beta-7] integrin and selectively prevents the infiltration of leukocytes into the gastrointestinal submucosa. It is thus an almost 'gut-selective' agent as opposed to previous biologics, which have a more systemic effect,” Colombel said in a press release. The trials were placebo-controlled, double-blind, and open-label, and included a total of 2,830 patients from May 2003 to June 2013. Patients with both ulcerative colitis (UC) and Crohn's disease (CD) took part in the study, and altogether they added up to a total of 4,811 person-years of exposure. Patients were followed up to five years, providing reliable long-term data. The study, titled "