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

Autor: Nakamura S; Osaka Medical and Pharmaceutical University, Osaka, Japan., Wada M; Tohoku University Hospital, Sendai, Miyagi, Japan. wada@ped-surg.med.tohoku.ac.jp., Mizushima T; Osaka University Hospital, Suita, Osaka, Japan., Sugita A; Yokohama Municipal Citizen's Hospital, Yokohama, Kanagawa, Japan., Tazuke Y; Osaka University Hospital, Suita, Osaka, Japan., Ohge H; Hiroshima University Hospital, Hiroshima, Japan., Udagawa E; Takeda Pharmaceutical Company Limited, Tokyo, Japan., Suzuki RK; Takeda Pharmaceutical Company Limited, Tokyo, Japan., Yoon M; Takeda Pharmaceutical Company, Cambridge, MA, USA., Grimm A; Shire Human Genetic Therapies, Inc., a Takeda Company, Cambridge, MA, USA.; Ultragenyx Pharmaceutical Inc, Novato, CA, USA., Chen ST; Takeda Pharmaceutical Company, Cambridge, MA, USA., Ikeuchi H; Hospital of Hyogo College of Medicine, Nishinomiya, Hyogo, Japan.
Jazyk: angličtina
Zdroj: Surgery today [Surg Today] 2023 Mar; Vol. 53 (3), pp. 347-359. Date of Electronic Publication: 2022 Oct 06.
DOI: 10.1007/s00595-022-02587-4
Abstrakt: Purpose: The short- and long-term efficacy, safety, and pharmacokinetics of teduglutide were analyzed in adult Japanese patients with short bowel syndrome and intestinal failure (SBS-IF).
Methods: Patients received teduglutide 0.05 mg/kg/day in clinical trials (TED-C14-004, SHP633-306, and extension SHP633-307). Data were analyzed at 24 weeks and an interim data cut-off of 4.5 years.
Results: The parenteral support (PS) volume decreased by ≥ 20% for 9/18 patients at 24 weeks and in all 11 patients by data cut-off in SHP633-307. The mean (standard deviation) PS volume decreased from baseline at 24 weeks in TED-C14-004 (-30.1 ± 25.9%) and SHP633-306 (-25.6 ± 25.5%), and at data cut-off in SHP633-307 (-57.08 ± 28.49%). 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.
Conclusions: 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.
(© 2022. The Author(s).)
Databáze: MEDLINE
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