Safety, efficacy, and pharmacokinetics of icatibant treatment in Japanese pediatric patients with hereditary angioedema: A phase 3, open-label study.

Autor: Hide M; Department of Dermatology, Hiroshima Citizens Hospital, Hiroshima, Japan.; Department of Dermatology, Graduate School of Biomedical & Health Sciences, Hiroshima University, Hiroshima, Japan., Wang Y; Quantitative Clinical Pharmacology, Takeda Development Center Americas Inc., Cambridge, Massachusetts, USA., Dote N; PRA Development Center KK, Osaka, Japan., Miyakawa K; Takeda Development Center Japan, Takeda Pharmaceutical Company Limited, Osaka, Japan., Sugiura K; Takeda Development Center Japan, Takeda Pharmaceutical Company Limited, Osaka, Japan., Ishida K; Takeda Development Center Japan, Takeda Pharmaceutical Company Limited, Osaka, Japan.
Jazyk: angličtina
Zdroj: The Journal of dermatology [J Dermatol] 2023 Nov; Vol. 50 (11), pp. 1473-1477. Date of Electronic Publication: 2023 Jun 29.
DOI: 10.1111/1346-8138.16883
Abstrakt: We evaluated the safety, efficacy, and pharmacokinetics of subcutaneous weight-adjusted icatibant for the treatment of acute hereditary angioedema attacks in Japanese pediatric patients. Two patients (aged 10-13 and 6-9 years) received icatibant for a total of four attacks. Each attack was abdominal and/or cutaneous and was treated with a single icatibant injection. Mild or moderate injection-site reactions were the only adverse events reported. Time to onset of symptom relief was 0.9-1.0 h. Icatibant was rapidly absorbed, with a pharmacokinetic profile consistent with previous studies. Simulated exposure levels were consistent with non-Japanese pediatric patients. These results support the safety and efficacy of icatibant in Japanese pediatric patients.
(© 2023 The Authors. The Journal of Dermatology published by John Wiley & Sons Australia, Ltd on behalf of Japanese Dermatological Association.)
Databáze: MEDLINE
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