Phase III VISIBLE 1 trial of subcutaneous Entyvio shows remission rates in ulcerative colitis.- Takeda.

Results from the phase III VISIBLE 1 clinical trial evaluating the efficacy and safety of an investigational subcutaneous (SC) formulation of the gut-selective biologic Entyvio (vedolizumab), from Takeda, shows remission rates for adult patients with moderately to severely active ulcerative colitis (UC) who achieved clinical response at week 6 following two doses of open-label vedolizumab intravenous (IV) induction therapy. The results show that at 52 weeks, a statistically significant proportion of patients receiving vedolizumab SC achieved clinical remission compared to patients receiving placebo (46.2% vs. 14.3%; p<0.001). a similar rate of clinical remission was observed in the vedolizumab iv reference arm 42.6.>

The VISIBLE 1 study also showed that subcutaneous (SC) vedolizumab was statistically superior to placebo in key secondary endpoints of mucosal healing (56.6% vs. 21.4%; p<0.001) and durable clinical response 64.2 vs. 28.6 p><0.001). vedolizumab sc was also numerically higher to placebo in achieving durable clinical remission 15.1 vs. 5.4 p="0.076)" and corticosteroid-free clinical remission 28.9 vs. 8.3 p="0.067)," with these results not being of statistical significance. similar findings were observed for these endpoints in the vedolizumab iv reference arm. additionally a subgroup analysis showed clinical remission rates were significantly higher with vedolizumab sc compared to placebo in anti-tumor necrosis factor-alpha tnf-nave 53.7 vs. 18.9 p><0.001) and anti-tnf-failure patients 33.3 vs. 5.3 p="0.023).">

Adverse event rates, including severe adverse events and infections, were similar in the vedolizumab SC and IV groups. Injection-site reactions were mild and experienced by 9.4% of patients in the vedolizumab SC treatment group (vs. 0 in the placebo group), with none leading to treatment discontinuation. Data were presented at the 2018 United European Gastroenterology (UEG) Week congress in Vienna, Austria.