Entyvio Improves Quality of Life, Work Productivity of Ulcerative Colitis Patients, Phase 3 Study Shows

Entyvio Improves Quality of Life, Work Productivity of Ulcerative Colitis Patients, Phase 3 Study Shows
Treatment with Entyvio (vedolizumab), delivered into the blood or under the skin, led to significant clinical improvements and in quality of life, as well as work productivity in patients with moderate-to-severe ulcerative colitis, a Phase 3 clinical trial showed. The results were presented in a poster titled “Effects of subcutaneous vedolizumab on health-related quality of life and work productivity in patients with ulcerative colitis: results from the Phase 3 VISIBLE 1 trial,” at the 14thCongress of ECCO, March 6-9 in Copenhagen, Denmark. The quality of life of patients with UC is often impaired, and clinical trials testing investigational therapies for UC also should include the therapy’s effects on this important outcome. Researchers analyzed data from the Phase 3 VISIBLE 1 trial, evaluating Takeda Pharmaceutical’s new subcutaneous (under-the-skin) form of Entyvio to assess the therapy’s effects in the UC patient’s quality of life and work productivity. The VISIBLE 1 (NCT02611830) recruited adult patients with moderate-to-severe UC who already had achieved a meaningful clinical response after receiving two doses of intravenous (injected into the blood) Entyvio, compared to a placebo. The trial evaluated the safety and effectiveness of Entyvio administered subcutaneously as a maintenance therapy. All patients first received a 300 mg infusion of Entyvio for six weeks (induction phase). Those showing a clinical response entered a maintenance phase in which they were randomized to one of three groups; group 1 received Entyvio administered subcutaneously at 108 mg (every two weeks) followed by intravenous placebo; group 2 received an intravenous injection of Entyvio at 300 mg (every eight weeks) followed by subcutaneous placebo injection
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