Document Detail


Efficacy and safety of Hizentra(®) in patients with primary immunodeficiency after a dose-equivalent switch from intravenous or subcutaneous replacement therapy.
MedLine Citation:
PMID:  21705277     Owner:  NLM     Status:  Publisher    
Abstract/OtherAbstract:
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 40weeks. 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 1.27h. Hizentra(®) maintained or improved serum IgG levels without dose increases and effectively protected patients against infections.
Authors:
S Jolles; E Bernatowska; J de Gracia; M Borte; V Cristea; H H Peter; B H Belohradsky; V Wahn; J Neufang-Hüber; O Zenker; B Grimbacher
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Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2011-6-12
Journal Detail:
Title:  Clinical immunology (Orlando, Fla.)     Volume:  -     ISSN:  1521-7035     ISO Abbreviation:  -     Publication Date:  2011 Jun 
Date Detail:
Created Date:  2011-6-27     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  100883537     Medline TA:  Clin Immunol     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
Copyright Information:
Copyright © 2011 Elsevier Inc. All rights reserved.
Affiliation:
University Hospital of Wales, Cardiff, UK.
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