Investigational Subcutaneous Formulation of Vedolizumab Meets Primary Endpoint in Achieving Clinical Remission at Week 52 in Patients with Moderately to Severely Active Crohn's Disease
- Vedolizumab subcutaneous is currently under review for approval for ulcerative colitis with the European Medicines Agency (EMA) and U.S. Food and Drug Administration (FDA)
Osaka, Japan, July 22, 2019 – Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) (“Takeda”) today announced top-line results from the VISIBLE 2 clinical trial evaluating the efficacy and safety of an investigational subcutaneous (SC) formulation of the gut-selective biologic vedolizumab as maintenance therapy in adult patients with moderately to severely active Crohn's disease (CD) who achieved clinical response* at week 6 following two doses of open-label vedolizumab intravenous (IV) therapy at weeks 0 and 2.
 In evaluating the primary endpoint of the trial, a statistically significant proportion of patients receiving vedolizumab SC achieved clinical remission** at week 52 compared to placebo. Patients received vedolizumab SC beginning at week 6 and every 2 weeks up to week 50.1 Adverse events were consistent with the known safety profile of vedolizumab IV, and no new signals were identified.
“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. 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,” said Asit Parikh, MD PhD, Head of Takeda’s Gastroenterology Therapeutic Area Unit.
These results will be shared with regulatory authorities and further data from the VISIBLE 2 trial will be presented at a future scientific congress. The subcutaneous formulation of vedolizumab forms part of Takeda’s ongoing commitment to meet the individual preferences of patients worldwide.
VISIBLE 2 is a phase 3, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of vedolizumab SC as maintenance therapy in patients with moderately to severely active CD.1 The study enrolled 644 participants, all of whom had an inadequate response with, loss of response to, or intolerance to corticosteroids, immunomodulators, or tumor necrosis factor-alpha (TNFα)-antagonist therapy prior to being enrolled.1 Patients who achieved clinical response at week 6 (n=410), following two doses of open-label vedolizumab 300 mg IV therapy at weeks 0 and 2, were randomized into one of two treatment groups, vedolizumab 108 mg SC or placebo SC.1 Both treatment groups received a subcutaneous injection every two weeks starting at week 6 up to week 50.1
* Clinical response is defined as a ≥70 point decrease in Crohn's Disease Activity Index (CDAI) score from baseline (week 0).2
** Clinical remission is defined as a Crohn's Disease Activity Index (CDAI) score ≤150 at week 52.1