Efficacy and safety of vedolizumab subcutaneous formulation in a randomized trial of patients with ulcerative colitis
Gastroenterology Nov 17, 2019
Sandborn WJ, Baert F, Danese S, et al. - In individuals with moderately to severely active ulcerative colitis (UC), researchers tested the safety and effectiveness of vedolizumab subcutaneous as a maintenance treatment. This investigation was conducted at 141 sites in 29 countries from December 18, 2015, through August 21, 2018. Open-label treatment with intravenous vedolizumab 300 mg was given to individuals with moderately to severely active UC at weeks 0 and 2. At week 6, individuals with clinical response were randomly assigned subcutaneous vedolizumab (108 mg) maintenance treatment every 2 weeks, 300 mg intravenous vedolizumab every 8 weeks, or placebo. Of the 216 individuals randomly allocated to groups, 46.2%, 42.6%, and 14.3% of individuals in the subcutaneous vedolizumab, intravenous vedolizumab, and placebo groups accomplished clinical remission at week 52. Moreover, the subcutaneous vedolizumab group had greater endoscopic improvement and durable clinical response at week 52 vs placebo. The results obtained from this phase 3, double-blind, double-dummy trial indicate that in individuals with moderately to severely active UC who had a clinical response to intravenous vedolizumab induction therapy, subcutaneous vedolizumab is effective as maintenance therapy. It has an advantageous profile of safety and tolerability.
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