title: Efficacy and safety of Hizentra(®) in patients with primary immunodeficiency after a dose-equivalent switch from intravenous or subcutaneous replacement therapy.
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.
authors.affiliation: University Hospital of Wales, Cardiff, UK. jollessr@cardiff.ac.uk
authors.forename: S
authors.initials: S
authors.lastname: Jolles
authors.forename: E
authors.initials: E
authors.lastname: Bernatowska
authors.forename: J
authors.initials: J
authors.lastname: de Gracia
authors.forename: M
authors.initials: M
authors.lastname: Borte
authors.forename: V
authors.initials: V
authors.lastname: Cristea
authors.forename: H H
authors.initials: HH
authors.lastname: Peter
authors.forename: B H
authors.initials: BH
authors.lastname: Belohradsky
authors.forename: V
authors.initials: V
authors.lastname: Wahn
authors.forename: J
authors.initials: J
authors.lastname: Neufang-Hüber
authors.forename: O
authors.initials: O
authors.lastname: Zenker
authors.forename: B
authors.initials: B
authors.lastname: Grimbacher
mesh_terms: D000293:Adolescent; D000328:Adult; D000361:Agammaglobulinemia / Q000097:blood / Q000276:immunology / Q000628:therapy; D002648:Child; D002675:Child, Preschool; D017074:Common Variable Immunodeficiency / Q000097:blood / Q000276:immunology / Q000628:therapy; D005260:Female; D040181:Genetic Diseases, X-Linked / Q000097:blood / Q000276:immunology / Q000628:therapy; D006801:Humans; D007074:Immunoglobulin G / Q000008:administration & dosage* / Q000009:adverse effects / Q000097:blood; D016756:Immunoglobulins, Intravenous / Q000008:administration & dosage / Q000009:adverse effects / Q000097:blood; D007153:Immunologic Deficiency Syndromes / Q000097:blood / Q000276:immunology / Q000628:therapy*; D007262:Infusions, Intravenous; D055104:Infusions, Subcutaneous; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: C558471:Hizentra; D007074:Immunoglobulin G; D016756:Immunoglobulins, Intravenous