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VISIBLE results from vedolizumab
OSAKA, Japan—Takeda Pharmaceutical Co. Ltd. had positive clinical data to share this week from its VISIBLE 2 trial of an investigational subcutaneous (SC) formulation of its gut-selective biologic vedolizumab. The trial explored vedolizumab as a maintenance therapy in adults with moderately to severely active Crohn's disease who achieved clinical response—which was defined as a ≥70 point decrease in Crohn's Disease Activity Index (CDAI) score from baseline (week 0)—at week six after two doses of open-label vedolizumab intravenous therapy at weeks 0 and 2. A statistically significant number of patients who received vedolizumab subcutaneously achieved clinical remission at week 52 compared to placebo, with clinical remission defined as a Crohn's Disease Activity Index (CDAI) score ≤150.
The VISIBLE 2 study is a Phase 3, randomized, double-blind, placebo-controlled trial assessing the safety and efficacy of vedolizumab SC as a maintenance therapy in patients with moderately to severely active Crohn's disease. A total of 644 patients were enrolled who had demonstrated an inadequate response with, loss of response to, or intolerance of corticosteroids, immunomodulators or tumor necrosis factor alpha-antagonist therapy. Patients who demonstrated a clinical response to vedolizumab IV therapy were randomized into one of two treatment groups: vedolizumab 108 mg SC or placebo SC. Both groups received a subcutaneous injection every two weeks from week 6 to week 50. Adverse events were in line with those seen from the safety profile of vedolizumab IV, with no new safety signals identified. Takeda intends to share additional data at a future scientific congress.
“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 Dr. Asit Parikh, head of Takeda’s Gastroenterology Therapeutic Area Unit.
This is not the only indication in which Takeda is advancing vedolizumab. The compound is currently under review for approval in ulcerative colitis by the U.S. Food and Drug Administration and the European Medicines Agency.
Along those lines, in mid-May Takeda released additional results from its Phase 3b head-to-head VARSITY study, which compared vedolizumab and adalimumab (Humira) in patients with moderately to severly active ulcerative colitis. The new exploratory data demonstrated that 67.1 percent of patients receiving vedolizumab IV achieved clinical response at week 14, compared to 45.9 percent of patients receiving adalimumab subcutaneous. The study also looked as histologic disease activity, an endpoint for determining the degree of microscopic inflammation in the gut. When judged by the Geboes Score and Robarts Histopathology Index severity thresholds of <3.2 and <5, vedolizumab treatment resulted in absence of active histologic disease in 33.4 percent and 42.3 percent of patients, respectively, compared with 13.7 percent and 25.6 percent of patients treated with adalimumab, respectively.
“Patients benefit from clinical trials that advance our understanding of the disease. The VARSITY study, a first-of-its-kind comparison of two biologics in ulcerative colitis, provides valuable information that can help inform treatment decisions, while also increasing our understanding of how these treatments are working at a microscopic level,” Dr. Jeff Bornstein, executive medical director for Takeda, commented regarding the results. “Data from the VARSITY study show consistent results for vedolizumab, supporting the use of this treatment as a first-line biologic therapy in ulcerative colitis.”