Elsevier

Clinical Immunology

Volume 141, Issue 1, October 2011, Pages 90-102
Clinical Immunology

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

https://doi.org/10.1016/j.clim.2011.06.002Get rights and content
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open access

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.

Research highlights

► We evaluated efficacy and safety of Hizentra® in primary immunodeficiency patients. ► Patients received weekly SCIG infusions at doses equivalent to previous treatment. ► IgG levels were maintained or increased with treatment. ► The annualized rate of all infections was 5.18 per patient. ► No serious treatment-related adverse events were reported.

Keywords

Primary immunodeficiency;
Subcutaneous IgG;
IgPro20;
Hizentra;
IgG levels;
Local reactions;

Cited by (0)

1

On behalf of the investigators. Germany: M. Borte, Municipal Hospital “St. Georg” GmbH Leipzig and Academic Teaching Hospital of the University of Leipzig, Leipzig (5 patients), W. Mannhardt-Laakmann, Universitäts-Kinderklinik der Johannes Gutenberg Universität, Mainz (2 patients), H. H. Peter, Universitätsklinikum Freiburg, Freiburg (3 patients), V. Wahn, Charité Campus Virchow-Klinikum, Berlin (4 patients); France: M. Debré, Hôpital Necker—Enfants malades, Paris (2 patients); Poland: E. Bernatowska, Child Health Institute, Warsaw (8 patients); Romania: V. Cristea, Clinica Medicala III, Cluj-Napoca (5 patients), M. Serban, Clinica III Pediatrie “Louis Turcanu”, Temesvar (5 patients); Spain: J. de Gracia, Hospital Vall d'Hebron, Barcelona (7 patients), T. González Quevedo, Hospitales Universitarios Virgen del Rocío, Sevilla (3 patients); Sweden: A. Fasth, The Queen Silvia Children's Hospital, Gothenburg (1 patient); Switzerland: A. Helbling, University Hospital Inselspital, Berne (2 patients); United Kingdom: B. Grimbacher, Royal Free Hospital and University College Medical School, London (2 patients), S. Jolles, University Hospital of Wales, Cardiff (1 patient), H. Longhurst, The Royal London Hospital, London (1 patient).