Efficacy and safety of Hizentra® in patients with primary immunodeficiency after a dose-equivalent switch from intravenous or subcutaneous replacement therapy

Jolles, Stephen, Bernatowska, E., de Gracia, J., Borte, M., Cristea, V., Peter, H. H., Belohradsky, B. H., Wahn, V., Neufang-Hüber, J., Zenker, O. and Grimbacher, B. 2011. Efficacy and safety of Hizentra® in patients with primary immunodeficiency after a dose-equivalent switch from intravenous or subcutaneous replacement therapy. Clinical Immunology 141 (1) , pp. 90-102. 10.1016/j.clim.2011.06.002

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Abstract

A prospective, open-label, multicenter, single-arm, Phase III study evaluated the efficacy and safety of Hizentra®, a 20% human IgG for subcutaneous administration, in 51 primary immunodeficiency patients over 40 weeks. Patients previously on intravenous or subcutaneous IgG were switched to weekly subcutaneous infusions of Hizentra® at doses equivalent to their previous treatment. IgG levels achieved with Hizentra® were similar to pre-study levels with subcutaneous, and higher by 17.7% than pre-study levels with intravenous IgG. No serious bacterial infections were reported in the efficacy period. The rate of all infections was 5.18/year/patient, the rates of days missed from work/school, and days spent in hospital were 8.00/year/patient and 3.48/year/patient, respectively. Local reactions (rate 0.060/infusion) were mostly mild (87.3%). No serious, Hizentra®-related adverse events were reported. Individual median infusion durations ranged between 1.14 and 1.27 h. Hizentra® maintained or improved serum IgG levels without dose increases and effectively protected patients against infections.

Item Type:	Article
Date Type:	Publication
Status:	Published
Schools:	Medicine
Subjects:	R Medicine > R Medicine (General) R Medicine > RM Therapeutics. Pharmacology
Uncontrolled Keywords:	primary immunodeficiency, subcutaneous IgG, IgPro20, Hizentra, IgG levels, local reactions
Publisher:	Springer
ISSN:	1521-6616
Last Modified:	04 Jun 2017 03:38
URI:	https://orca.cardiff.ac.uk/id/eprint/24160

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