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

Clin Immunol. 2011 Oct;141(1):90-102. doi: 10.1016/j.clim.2011.06.002. Epub 2011 Jun 12.


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.

Publication types

  • Clinical Trial, Phase III
  • Comparative Study
  • Multicenter Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Adult
  • Agammaglobulinemia / blood
  • Agammaglobulinemia / immunology
  • Agammaglobulinemia / therapy
  • Child
  • Child, Preschool
  • Common Variable Immunodeficiency / blood
  • Common Variable Immunodeficiency / immunology
  • Common Variable Immunodeficiency / therapy
  • Female
  • Genetic Diseases, X-Linked / blood
  • Genetic Diseases, X-Linked / immunology
  • Genetic Diseases, X-Linked / therapy
  • Humans
  • Immunoglobulin G / administration & dosage*
  • Immunoglobulin G / adverse effects
  • Immunoglobulin G / blood
  • Immunoglobulins, Intravenous / administration & dosage
  • Immunoglobulins, Intravenous / adverse effects
  • Immunoglobulins, Intravenous / blood
  • Immunologic Deficiency Syndromes / blood
  • Immunologic Deficiency Syndromes / immunology
  • Immunologic Deficiency Syndromes / therapy*
  • Infusions, Intravenous
  • Infusions, Subcutaneous
  • Male
  • Middle Aged
  • Prospective Studies
  • Treatment Outcome
  • Young Adult


  • Hizentra
  • Immunoglobulin G
  • Immunoglobulins, Intravenous

Supplementary concepts

  • Agammaglobulinemia, non-Bruton type
  • Bruton type agammaglobulinemia