Japan-based Takeda Pharmaceutical Co. Ltd.'s Entyvio was shown to improve symptoms of an inflammatory bowel disease better than AbbVie Inc.'s Humira in a late-stage study.
The phase 3b head-to-head trial, called Varsity, evaluated the efficacy and safety of Entyvio compared to blockbuster drug Humira after 52 weeks in patients with moderately to severely active ulcerative colitis — a chronic inflammatory condition of the gastrointestinal tract that is often progressive. Ulcerative colitis causes symptoms of abdominal discomfort and loose bowel movements.
Statistically significant results from the Varsity trial showed that 31.3% of patients who were given Entyvio, also known as vedolizumab, intravenously achieved clinical remission — the study's main goal — compared to 22.5% of patients given Humira subcutaneously, or through the skin.
Clinical remission is characterized as a decrease or disappearance of the disease's symptoms as measured by an index called the Mayo score.
Meanwhile, more patients taking Entyvio achieved mucosal healing — a secondary goal of the study — compared to patients taking Humira, or adalimumab. Patients taking Entyvio also had a lower rate of adverse events and infections over 52 weeks compared to those given Humira.