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

Stephen Jolles, Michael Borte, Robert P. Nelson, Mikhail Rojavin, Martin Bexon, John Philip Lawo, Richard L. Wasserman

Research output: Contribution to journalArticle

17 Scopus citations

Abstract

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.

Original languageEnglish (US)
Pages (from-to)161-169
Number of pages9
JournalClinical Immunology
Volume150
Issue number2
DOIs
StatePublished - Feb 1 2014

Keywords

  • 20% SCIG
  • Hizentra
  • Primary immunodeficiency
  • Subcutaneous immunoglobulin

ASJC Scopus subject areas

  • Immunology and Allergy
  • Immunology

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