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Long-term efficacy, safety, and tolerability of Hizentra® for treatment of primary immunodeficiency disease

Jolles, Stephen, Borte, Michael, Nelson, Robert P., Rojavin, Mikhail, Bexon, Martin, Lawo, John-Philip and Wasserman, Richard L. 2014. Long-term efficacy, safety, and tolerability of Hizentra® for treatment of primary immunodeficiency disease. Clinical Immunology 150 (2) , pp. 161-169. 10.1016/j.clim.2013.10.008

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Hizentra® (20% subcutaneous immunoglobulin [SCIG]) was administered to subjects with primary immunodeficiency disease in two extension studies in the EU and US to assess long-term efficacy and tolerability. Subjects (aged 4–69 years) were treated for 148 weeks in the EU (N = 40; 5405 infusions) and 87 weeks in the US (N = 21; 1735 infusions). Weekly doses were 116.0 mg/kg (EU) and 193.2 mg/kg (US); IgG levels were 7.97 g/L (EU) and 11.98 g/L (US). Annualized rates of serious bacterial infections were 0.05 infections/subject/year (EU) and 0.06 infections/subject/year (US). Rates of any infection were 3.33 infections/subject/year (EU) and 2.38 infections/subject/year (US). The rate of bronchopulmonary infections was higher in the EU study. No treatment-related serious AEs occurred; no subject discontinued because of treatment-related AEs. Self-administered Hizentra afforded sustained effective protection from infections and favorable tolerability during an extended treatment period of up to 3 years.

Item Type: Article
Date Type: Publication
Status: Published
Schools: Medicine
Publisher: Elsevier
ISSN: 1521-6616
Funders: CSL Behring
Date of First Compliant Deposit: 7 January 2019
Date of Acceptance: 15 October 2013
Last Modified: 05 May 2023 18:01

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