Vedolizumab in Japanese patients with ulcerative colitis: A Phase 3, randomized, double-blind, placebo-controlled study

PloS One
Satoshi MotoyaToshifumi Hibi

Abstract

Vedolizumab safety and efficacy have been established in many populations all over the world, but have never been studied in Japan. We report results from a Phase 3, randomized, double-blind, placebo-controlled study of vedolizumab in Japanese patients with active ulcerative colitis (UC). Patients with moderate-to-severe UC were enrolled into Cohort 1 (double-blinded) or Cohort 2 (open-label) in the induction phase. Cohort 1 was randomized 2:1 to receive 300 mg vedolizumab or placebo, while Cohort 2 received vedolizumab 300 mg only, at Weeks 0, 2, and 6. Patients from Cohorts 1 and 2 showing a clinical response to vedolizumab at Week 10 were randomized 1:1 to receive vedolizumab or placebo (double-blinded) at Week 14 and then every 8 weeks up to Week 54 as the maintenance phase. The primary endpoint was clinical response at Week 10, for the induction phase, and clinical remission at Week 60, for the maintenance phase. A total of 292 patients were enrolled into the induction phase (246 in Cohort 1, 46 in Cohort 2); 83 patients achieved response to vedolizumab and were subsequently enrolled into the maintenance phase. Clinical response rates at Week 10 were 39.6% (65/164) and 32.9% (27/82) in the vedolizumab and placebo groups in...Continue Reading

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Citations

Oct 12, 2020·Clinical Journal of Gastroenterology·Aiko IkeuchiMuneaki Matsuo
Mar 2, 2021·Journal of Managed Care & Specialty Pharmacy·Rajshree PandeySteven D Pearson
Apr 23, 2021·Journal of Gastroenterology·Hiroshi NakaseKazuhiko Koike
Aug 20, 2021·Journal of Gastroenterology and Hepatology·Makoto NaganumaTakanori Kanai

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Clinical Trials Mentioned

NCT02039505

Software Mentioned

GEMINI
SAS

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