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Efficacy and safety of Hizentra®, a new 20% immunoglobulin preparation for subcutaneous administration, in pediatric patients with primary immunodeficiency

Borte, Michael, Pac, Malgorzata, Serban, Margit, Gonzalez-Quevedo, Teresa, Grimbacher, Bodo, Jolles, Stephen, Zenker, Othmar, Neufang-Hueber, Jutta and Belohradsky, Bernd 2011. Efficacy and safety of Hizentra®, a new 20% immunoglobulin preparation for subcutaneous administration, in pediatric patients with primary immunodeficiency. Journal of Clinical Immunology 31 (5) , pp. 752-761. 10.1007/s10875-011-9557-z

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Abstract

Subcutaneous IgG treatment for primary immunodeficiencies (PI) is particularly well suited for children because it does not require venous access and is mostly free of systemic adverse events (AEs). In a prospective, open-label, multicenter, single-arm, Phase III study, 18 children and five adolescents with PI were switched from previous intravenous (IVIG) or subcutaneous (SCIG) IgG treatment to receive dose-equivalent, weekly subcutaneous infusions of Hizentra® for 40 weeks. Mean IgG trough levels were maintained in patients previously on SCIG, or increased in those previously on IVIG, regardless of age. No serious bacterial infections were reported during the efficacy period of the study. The rates of non-serious infections were 4.77 (children) and 5.18 (adolescents) infections per patient per year. Related AEs were observed in seven children (38.9%) and two adolescents (40%). Three serious AEs and two AEs leading to discontinuation (all unrelated) were reported in children. Hizentra® is an effective and well-tolerated treatment for pediatric patients.

Item Type: Article
Date Type: Publication
Status: Published
Schools: Biosciences
Medicine
Subjects: R Medicine > R Medicine (General)
R Medicine > RJ Pediatrics > RJ101 Child Health. Child health services
R Medicine > RM Therapeutics. Pharmacology
Uncontrolled Keywords: subcutaneous immunoglobulin (SCIG), primary immunodeficiency, local tolerability, serum IgG levels, pediatric patients
Publisher: Springer
ISSN: 0271-9142
Last Modified: 04 Jun 2017 03:36
URI: http://orca-mwe.cf.ac.uk/id/eprint/23348

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