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Data were analyzed at 24\u00a0weeks and an interim data cut-off of 4.5\u00a0years.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>The parenteral support (PS) volume decreased by\u2009\u2265\u200920% for 9\/18 patients at 24\u00a0weeks and in all 11 patients by data cut-off in SHP633-307. The mean (standard deviation) PS volume decreased from baseline at 24\u00a0weeks in TED-C14-004 (\u221230.1\u2009\u00b1\u200925.9%) and SHP633-306 (\u221225.6\u2009\u00b1\u200925.5%), and at data cut-off in SHP633-307 (\u221257.08\u2009\u00b1\u200928.49%). Teduglutide was absorbed quickly. The adverse events were consistent with the underlying disease and known adverse drug reactions. Anti-teduglutide antibody titers declined with long-term treatment.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>In Japanese adults with SBS-IF, teduglutide treatment was associated with clinically meaningful reductions in PS requirements, similar to findings in prior international studies. No new safety concerns specific to the Japanese SBS-IF patient population were identified with short- or long-term teduglutide treatment. Anti-teduglutide antibody titers disappeared in most Japanese adults with long-term treatment. These results constitute the longest evaluation of teduglutide treatment within clinical trials reported to date.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1007\/s00595-022-02587-4","type":"journal-article","created":{"date-parts":[[2022,10,6]],"date-time":"2022-10-06T07:02:57Z","timestamp":1665039777000},"page":"347-359","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":17,"title":["Efficacy, safety, and pharmacokinetics of teduglutide in adult Japanese patients with short bowel syndrome and intestinal failure: two phase III studies with an extension"],"prefix":"10.1007","volume":"53","author":[{"given":"Shiro","family":"Nakamura","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Motoshi","family":"Wada","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tsunekazu","family":"Mizushima","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Akira","family":"Sugita","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yuko","family":"Tazuke","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hiroki","family":"Ohge","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eri","family":"Udagawa","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ryohsuke Ken","family":"Suzuki","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"MinJung","family":"Yoon","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andrew","family":"Grimm","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Szu-Ta","family":"Chen","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hiroki","family":"Ikeuchi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2022,10,6]]},"reference":[{"key":"2587_CR1","doi-asserted-by":"publisher","first-page":"247","DOI":"10.1016\/j.clnu.2016.01.020","volume":"35","author":"L Pironi","year":"2016","unstructured":"Pironi L, Arends J, Bozzetti F, Cuerda C, Gillanders L, Jeppesen PB, et al. 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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.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}},{"value":"These 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\u2019s Hospital<u>,<\/u> and Tohoku University Hospital. Written informed consent was obtained from all patients.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethical approval"}}]}}