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Effects of vedolizumab in Japanese patients with Crohn's disease: a prospective, multicenter, randomized, placebo-controlled Phase 3 trial with exploratory analyses.

  • Watanabe, Kenji1
  • Motoya, Satoshi2
  • Ogata, Haruhiko3
  • Kanai, Takanori4
  • Matsui, Toshiyuki5
  • Suzuki, Yasuo6
  • Shikamura, Mitsuhiro7
  • Sugiura, Kenkichi7
  • Oda, Kazunori8
  • Hori, Tetsuharu7
  • Araki, Takahiro7
  • Watanabe, Mamoru9
  • Hibi, Toshifumi10
  • 1 Department of Intestinal Inflammation Research, Hyogo College of Medicine, Hyogo, Japan. , (Japan)
  • 2 IBD Center, Hokkaido Prefectural Welfare Federation of Agricultural Cooperative, Sapporo-Kosei General Hospital, Sapporo, Japan. , (Japan)
  • 3 Endoscopic Center, Keio University School of Medicine, Tokyo, Japan. , (Japan)
  • 4 Division of Gastroenterology and Hepatology, Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan. , (Japan)
  • 5 Department of Gastroenterology, Fukuoka University Chikushi Hospital, Fukuoka, Japan. , (Japan)
  • 6 Department of Internal Medicine, Toho University Medical Center Sakura Hospital, Chiba, Japan. , (Japan)
  • 7 Takeda Development Center Japan, Takeda Pharmaceutical Company Limited, Osaka, Japan. , (Japan)
  • 8 Regenerative Medicine Unit, Takeda Pharmaceutical Company Limited, Kanagawa, Japan. , (Japan)
  • 9 Department of Gastroenterology and Hepatology, Tokyo Medical and Dental University, Tokyo, Japan. , (Japan)
  • 10 Center for Advanced Inflammatory Bowel Disease Research and Treatment, Kitasato University Kitasato Institute Hospital, 5-9-1 Shirokane, Minato-ku, Tokyo, 108-8462, Japan. [email protected] , (Japan)
Published Article
Journal of gastroenterology
Publication Date
Mar 01, 2020
DOI: 10.1007/s00535-019-01647-w
PMID: 31836930


Vedolizumab is a gut-selective humanized antibody that binds the α4β7 integrin. We evaluated efficacy and safety of vedolizumab in Japanese patients with moderate-to-severe Crohn's disease (CD). In this Phase 3, double-blind study (NCT02038920), 157 patients were randomized to receive intravenous vedolizumab 300 mg (n = 79) or placebo (n = 78) at Weeks 0, 2, and 6 (induction phase). Patients with CD activity index (CDAI)-70 response at Week 10 were randomized to receive vedolizumab 300 mg (n = 12) or placebo (n = 12) at Week 14, then every 8 weeks until Week 54 (maintenance phase). Primary endpoints were ≥ 100-point reduction in CDAI (CDAI-100 response) at Week 10 for induction, and clinical remission (CR: CDAI ≤ 150) at Week 60 for maintenance. At Week 10, 26.6% of patients who received vedolizumab and 16.7% who received placebo achieved CDAI-100 response (odds ratio [OR] [95% confidence interval (CI)] 1.80 [0.82-3.96]; p = 0.145). At Week 60, 41.7% of vedolizumab-treated patients and 16.7% of placebo-treated patients achieved CR (OR [95% CI] 3.57 [0.53-23.95]; p = 0.178). The incidence of adverse events was similar in both treatment groups in both induction and maintenance phases. In patients without prior anti-TNFα exposure or with inadequate response to anti-TNFα, vedolizumab showed improved outcomes over placebo in the induction phase. Age might be a possible predictive factor of CR for future research. Vedolizumab showed a numerically greater efficacy versus placebo as induction therapy, but the difference was not statistically significant. Vedolizumab also showed a numerically greater efficacy in maintenance therapy, and was well tolerated.

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