Subcutaneous Entyvio safe, effective for long-term maintenance of UC
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The interim analysis of subcutaneous Entyvio demonstrates the treatment is safe and effective for long-term maintenance of ulcerative colitis, according to results presented at UEG Week.
“These findings support the use of vedolizumab SC (vedolizumab, Takeda) at a dose of 108 mg every 2 weeks as a safe and effective alternative to IV administration for long-term maintenance treatment of patients with UC,” Séverine Vermeire, MD, PhD, from the University Hospital Leuven, Belgium.
The VISIBLE open-label extension is an ongoing, multinational, multicenter phase 3 study of patients with UC enrolled for the VISIBLE 1 study and patients with Crohn’s disease enrolled in VISIBLE 2.
There were 288 patients from VISIBLE 1 who completed 52 weeks of treatment and were enrolled in VISIBLE OLE. They received vedolizumab 108 mg subcutaneous (SC) every 2 weeks. Nonrandomized week 14 responders from VISIBLE 1 after receiving an additional third IV induction dose of vedolizumab received vedolizumab SC 108 mg every 2 weeks during the VISIBLE OLE study.
Vermeire and colleagues evaluated safety as the primary endpoint. Long-term clinical remission and corticosteroid-free clinical remission served as clinical efficacy outcomes.
Results showed adverse events occurred in 69% of patients with UC and serious adverse events occurred in 14% of patients.
Vermeire noted clinical remission rates were maintained from week 6 to week 108 in the VISIBLE 1 randomized completers and from week 14 to week 110 in the nonrandomized week 14 responders. VISIBLE 1 randomized completers maintained corticosteroid-free clinical remission rates from week 52 to week 108 and nonrandomized week 14 responders maintained rates from week 54 to week 110.
“Long-term safety findings of vedolizumab SC was consistent with the known safety profile of vedolizumab,” she said.
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Vermeire S, et al. OP090. Estimated effects of screening delays due to SARS-CoV-2 pandemic on colorectal cancer mortality. Presented at: UEG Week; Oct. 11-13, 2020.
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