Efficacy, safety, and pharmacokinetics of teduglutide in adult Japanese patients with short bowel syndrome and intestinal failure: two phase III studies with an extension.

"Declarations Conflict of interestS.N. received Honoraria from Mitsubishi Tanabe Pharma, EA Pharma Co., Ltd., Janssen Pharmaceutical Co., Ltd., Mochida Pharmaceutical Co., Ltd., Takeda Pharmaceutical Co., Ltd., and AbbVie Inc., and has received research funding from Mitsubishi Tanabe Pharma. M.W. received research funding from Shire, a Takeda company. T.M. received research funding from Shire International GmbH, Takeda Pharmaceuticals; Asahi Kasei Pharma; Taiho Pharmaceutical; Chugai Pharmaceutical; Yakult Honsha; Eli Lilly Japan; Ono Pharmaceutical; Sanofi; Kaken Pharmaceutical; and Mitsubishi Tanabe Pharma; and holds a chair endowed by Kinshukai Medical Corporation. E.U. and R.K.S. are employees of Takeda Pharmaceutical Company Limited, Tokyo, Japan. M.Y. and S.C. are employees of Takeda Pharmaceutical Company, Cambridge, MA, USA. A.G. was a former employee of Shire Human Genetic Therapies, Inc., a Takeda company, MA, USA. A.S., Y.T., H.O., and H.I. have no conflicts to disclose. Ethical approvalThese studies were performed in accordance with the World Medical Association Declaration of Helsinki and applicable laws and standards of good clinical practice in Japan. The study protocols, any protocol amendments, the final approved informed consent documents, relevant supporting information, and all types of patient recruitment information were approved by the institutional review boards of Hospital of Hyogo College of Medicine, Osaka University Hospital, Yokohama Municipal Citizen’s Hospital, and Tohoku University Hospital. Written informed consent was obtained from all patients. Conflict of interest S.N. received Honoraria from Mitsubishi Tanabe Pharma, EA Pharma Co., Ltd., Janssen Pharmaceutical Co., Ltd., Mochida Pharmaceutical Co., Ltd., Takeda Pharmaceutical Co., Ltd., and AbbVie Inc., and has received research funding from Mitsubishi Tanabe Pharma. M.W. received research funding from Shire, a Takeda company. T.M. received research funding from Shire International GmbH, Takeda Pharmaceuticals; Asahi Kasei Pharma; Taiho Pharmaceutical; Chugai Pharmaceutical; Yakult Honsha; Eli Lilly Japan; Ono Pharmaceutical; Sanofi; Kaken Pharmaceutical; and Mitsubishi Tanabe Pharma; and holds a chair endowed by Kinshukai Medical Corporation. E.U. and R.K.S. are employees of Takeda Pharmaceutical Company Limited, Tokyo, Japan. M.Y. and S.C. are employees of Takeda Pharmaceutical Company, Cambridge, MA, USA. A.G. was a former employee of Shire Human Genetic Therapies, Inc., a Takeda company, MA, USA. A.S., Y.T., H.O., and H.I. have no conflicts to disclose."

"Funding The clinical trials were funded by Shire Human Genetic Therapies, Inc., a Takeda company (Cambridge, MA, USA). The sponsor of the studies participated in the study design, data collection, data analysis, data interpretation, and review and approval of the final clinical study reports and provided the study drug."