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Efficacy, Safety, and Pharmacokinetics of a 10% Liquid Immune Globulin Preparation (GAMMAGARD LIQUID, 10%) Administered Subcutaneously in Subjects with Primary Immunodeficiency Disease

Authors :
Isaac Melamed
Mark R. Stein
William Grossman
Steven Strausbaugh
Werner Engl
Heinz Leibl
Lisa Kobrynski
Luba Sobolevsky
Marlies Sharkhawy
David Gelmont
Richard I. Schiff
Richard L. Wasserman
Source :
Journal of Clinical Immunology. 31:323-331
Publication Year :
2011
Publisher :
Springer Science and Business Media LLC, 2011.

Abstract

A multi-center, prospective, open-label study was conducted in primary immunodeficiency disease patients to determine the tolerability and pharmacokinetics of a 10% liquid IgG preparation administered subcutaneously. Forty-nine subjects (3–77 years old) were enrolled. Pharmacokinetic equivalence of subcutaneous treatment was achieved at a median dose of 137% of the intravenous dose, with a mean trough IgG level of 1,202 mg/dL at the end of the assessment period. The overall infection rate during subcutaneous treatment was 4.1 per subject-year. Three acute serious bacterial infections were reported, resulting in a rate of 0.067 per subject-year. A low overall rate of temporally associated adverse events (8%), and a very low rate of infusion site adverse events (2.8%), was seen at volumes up to 30 mL/site and rates ≤30 mL/h/site. Thus, subcutaneous replacement therapy with a 10% IgG preparation proved effective, safe and well-tolerated in our study population of subjects with primary immunodeficiency disease.

Details

ISSN :
15732592 and 02719142
Volume :
31
Database :
OpenAIRE
Journal :
Journal of Clinical Immunology
Accession number :
edsair.doi...........62954f2432b0bd2f9732e98a1a1bba68