Takeda announce PIII VISIBLE II study met primary endpoint. RCT (n=644) showed a statistically significant proportion of patients who received maintenance treatment with the SC formulation achieved clinical remission (defined as a CDAI score ≤150 at week 52) compared to placebo .
Takeda present additional results from PIIIb VARSITY study (n=769) at conference. At week 14 a larger proportion of patients receiving vedolizumab had a clinical response compared to those receiving adalimumab (67.1% vs 45.9% respectively) .
PIIIb VARSITY trial found vedolizumab superior to adalimumab in achieving clinical remission in patients with moderate to severe active ulcerative colitis at week 52. Of those treated with vedolizumab IV, 31.3% (n=120/383) achieved clinical remission (primary endpoint ) compared to 22.5% (n=87/386) of those treated with adalimumab subcutaneous (SC), (p=0.0061) .
Results from PIII VISIBLE 1 study announced at conference. At week 52, a statistically significant proportion of patients on SC vedolizumab 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 vedolizumab IV reference arm (42.6%) .
Commissioned by CCGs for adults, NHS England for children .
PIII VISIBLE-1 study (n=384) of vedolizumab for maintenance of UC achieves primary endpoint. Signifcantly more patients receiving vedolizumab achieved clinical remission at week 52 vs placebo. Safety data were consistent with IV vedolizumab (Entyvio) .
PIII trials (NCT02611830 and NCT02611817) are due to complete collecting primary outcome data in Aug 18 and Mar 2020, respectively .
Extension PIIIb trial to assess long-term safety and tolerability of vedolizumab 108mg SC in patients with ulcerative colitis (UC) and Crohn´s disease (CD) and have previously participated in the two PIII studies that started in Jan 16 starts (NCT02620046) .
Takeda initiates a PIII trial to assess safety and efficacy of vedolizumab 108mg SC injection q2w as maintenance treatment in patients with moderately to severely active Crohn´s disease (CD), who achieved clinical response following vedolizumab 300mg IV infusion induction therapy (NCT02611817). The double-blind, randomised, placebo-controlled, parallel group trial will enrol approximately 824 patients (aged 18 to 80 years); recruitment is underway in the US and Slovakia, and may expand to Australia, Belgium, Bosnia-Herzegovina, Brazil, Bulgaria, Canada, Chile, Colombia, Croatia, the Czech Republic, Denmark, Estonia, France, Germany, Hungary, Israel, Italy, Japan, Latvia, Lithuania, Mexico, the Netherlands, Poland, Portugal, Romania, Russia, Serbia, South Korea, Spain, Sweden, Turkey, Ukraine and the UK .
Takeda initiates a PIII trial to assess safety and efficacy of vedolizumab 108mg SC injection q2w as maintenance treatment, with a vedolizumab IV reference arm, in patients with moderately to severely active ulcerative colitis, who achieved clinical response following vedolizumab 300mg IV infusion q8w induction therapy (NCT02611830). The double-blind, randomised, placebo-controlled, parallel group trial will enrol approximately 400 patients (aged 18 to 80 years) in Belgium, Bulgaria, Croatia, the Czech Republic, Denmark, Estonia, France, Germany, Hungary, Italy, Latvia, Lithuania, the Netherlands, Poland, Portugal, Romania, Slovakia, Spain, Sweden, the US and the UK .