Journal of Clinical Immunology

, Volume 31, Issue 5, pp 752-761

First online:

Open Access This content is freely available online to anyone, anywhere at any time.

Efficacy and Safety of Hizentra®, a New 20% Immunoglobulin Preparation for Subcutaneous Administration, in Pediatric Patients with Primary Immunodeficiency

  • Michael BorteAffiliated withHospital St. Georg GmbH Leipzig, Academic Teaching Hospital of the University of Leipzig Email author 
  • , Malgorzata PacAffiliated withChild Health Institute, Clinic of Immunology
  • , Margit SerbanAffiliated withClinica III Pediatrie “Louis Turcanu”
  • , Teresa Gonzalez-QuevedoAffiliated withHospitales Universitarios Virgen del Rocío
  • , Bodo GrimbacherAffiliated withRoyal Free Hospital and University College Medical School
  • , Stephen JollesAffiliated withUniversity Hospital of Wales
  • , Othmar ZenkerAffiliated withCSL Behring GmbH
  • , Jutta Neufang-HueberAffiliated withCSL Behring AG
  • , Bernd BelohradskyAffiliated withDr. von Haunersches Kinderspital, University Children’s Hospital


Subcutaneous IgG treatment for primary immunodeficiencies (PI) is particularly well suited for children because it does not require venous access and is mostly free of systemic adverse events (AEs). In a prospective, open-label, multicenter, single-arm, Phase III study, 18 children and five adolescents with PI were switched from previous intravenous (IVIG) or subcutaneous (SCIG) IgG treatment to receive dose-equivalent, weekly subcutaneous infusions of Hizentra® for 40 weeks. Mean IgG trough levels were maintained in patients previously on SCIG, or increased in those previously on IVIG, regardless of age. No serious bacterial infections were reported during the efficacy period of the study. The rates of non-serious infections were 4.77 (children) and 5.18 (adolescents) infections per patient per year. Related AEs were observed in seven children (38.9%) and two adolescents (40%). Three serious AEs and two AEs leading to discontinuation (all unrelated) were reported in children. Hizentra® is an effective and well-tolerated treatment for pediatric patients.


Subcutaneous immunoglobulin (SCIG) primary immunodeficiency local tolerability serum IgG levels pediatric patients