Vedolizumab SC Induces Clinical Remission in Phase 3 Ulcerative Colitis Study
Data from the Phase 3 VISIBLE 1 trial demonstrated that treatment with an investigational subcutaneous (SC) formulation of vedolizumab led to clinical remission in patients with moderately to severely active ulcerative colitis (UC).
The study included 384 adult patients with moderately to severely active UC who 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. Patients who achieved clinical response at week 6 following 2 doses of open-label vedolizumab IV therapy were randomized to vedolizumab SC 108mg and placebo IV, vedolizumab IV 300mg and placebo SC, or placebo SC and placebo IV. Subcutaneous doses were administered every 2 weeks and IV doses every 8 weeks.
Results showed a statistically significant proportion of patients receiving vedolizumab SC achieved clinical remission (defined as a complete Mayo score of ≤2 points and no individual subscore greater than >1 point) at week 52 compared with placebo. In addition, the safety profile of the SC formulation was consistent with that of vedolizumab IV.
The full findings of the study will be presented at a future scientific congress.
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