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Prospective open‐label study of pharmacokinetics, efficacy and safety of a new 10% liquid intravenous immunoglobulin in patients with hypo‐ or agammaglobulinemia
Author(s) -
Björkander J.,
Nikoskelainen J.,
Leibl H.,
Lanbeck P.,
Wallvik J.,
Lumio J. T.,
Braconier J. H.,
Pavlova B. G.,
Birthistle K.,
Engl W.,
Walter S.,
Ehrlich H. J.
Publication year - 2006
Publication title -
vox sanguinis
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.68
H-Index - 83
eISSN - 1423-0410
pISSN - 0042-9007
DOI - 10.1111/j.1423-0410.2006.00764.x
Subject(s) - medicine , pharmacokinetics , adverse effect , antibody , primary immunodeficiency , intravenous infusions , immunoglobulin g , prospective cohort study , gastroenterology , immunology , immune system
Background and Objectives The aim of this study was to evaluate the pharmacokinetics, efficacy and safety of a newly developed 10% liquid immunoglobulin preparation in patients with primary immunodeficiency diseases. This new preparation for intravenous use includes three dedicated virus clearance steps in its manufacturing process to ensure a high margin of viral safety. Materials and Methods This was a prospective, open‐label, non‐controlled, multicentre study. Twenty‐two subjects with primary immunodeficiency were treated initially with three infusions of a licensed intravenous immunoglobulin to standardize the immunoglobulin G (IgG) replacement therapy of all subjects to the same intravenous product. A total of nine infusions of the new 10% liquid preparation were subsequently administered. Results The median terminal half‐life of total IgG following administration of the new preparation was 30·1 days. Median terminal half‐lives for IgG subclasses IgG 1 , IgG 2 , IgG 3 and IgG 4 were 28·3, 31·3, 20·9 and 24·2 days, respectively. The median total serum IgG steady‐state trough level was 8·51 g/l. No severe infection episodes started after initiation of treatment with the new preparation. The median rate of mild or moderate infection episodes was 0·48 per month. A total of 194 infusions with the new 10% liquid immunoglobulin preparation were administered. The mean dose per infusion was 0·41 g/kg body weight and the maximum infusion rates recorded were 8 ml/kg/h. Adverse experiences were mostly mild and unrelated to the study drugs. Only 4% of infusions with the new product were followed by one or more related adverse experiences. Conclusion The new 10% liquid immunoglobulin preparation was well tolerated and shown to have an excellent pharmacokinetic, efficacy and safety profile. The liquid formulation provides convenience to patients and healthcare professionals.