Takeda's subcutaneous formulation of Entyvio smashes primary endpoint in Crohn's disease

Takeda has unveiled new Phase 3 data for a subcutaneous formulation of its gut-selective biologic Entyvio (vedolizumab), showing that the therapy met its primary endpoint as a maintenance treatment for moderately to severely active Crohn's disease (CD).

The data was drawn from 644 trial participants who had not responded or responded inadequately to corticosteroids, immunomodulators, or tumor necrosis factor-alpha (TNFα)-antagonist therapy prior to enrolment. Patients were given the subcutaneous formulation of Takeda’s therapy at the beginning of week six, every two weeks until week 50.

The findings relate specifically to CD in adult patients who achieved clinical response at week six after receiving two doses of open-label vedolizumab intravenous (IV) therapy at weeks 0 and 2.

It was found that a “statistically significant” proportion of participants achieved clinical remission with Entyvio after 52 weeks of treatment compared to placebo, meeting the trial’s primary endpoint, while the therapy’s safety profile was found to be consistent with previous studies.

“Meeting the primary endpoint of the VISIBLE 2 study marks a crucial step in our efforts to help patients with Crohn’s disease as to how they may receive treatment with vedolizumab, whether that is intravenously or subcutaneously,” said Dr Asit Parikh, Head of Takeda’s Gastroenterology Therapeutic Area Unit. “These data, alongside the pivotal VISIBLE 1 results in ulcerative colitis, provide a more comprehensive picture of the new investigational subcutaneous formulation of vedolizumab as maintenance therapy for both ulcerative colitis and Crohn’s disease.”

Matt Fellows