Efficacy, safety and tolerability of a new 10% liquid intravenous immune globulin [IGIV 10%] in patients with primary immunodeficiency

• Published in: Journal of Clinical Immunology 2006-07, Vol.26 (4), p.388-395
• Main Authors: Church, Joseph A, Leibl, Heinz, Stein, Mark R, Melamed, Isaac R, Rubinstein, Arye, Schneider, Lynda C, Wasserman, Richard L, Pavlova, Borislava G, Birthistle, Karl, Mancini, Marianne, Fritsch, Sandor, Patrone, Lisa, Moore-Perry, Kerry, Ehrlich, Hartmut J
• Format: Article
• Language: English
• Subjects: Adolescent; Adult; Aged; Bacterial Infections - chemically induced; Child; Female; Headache - chemically induced; Humans; Immunoglobulins, Intravenous - administration & dosage; Immunoglobulins, Intravenous - pharmacokinetics; Immunoglobulins, Intravenous - toxicity; Immunologic Deficiency Syndromes - complications; Immunologic Deficiency Syndromes - drug therapy; Immunotherapy - adverse effects; Immunotherapy - methods; Incidence; Male; Middle Aged; Pharmacokinetics
• ISSN: 0271-9142; 1573-2592; 1365-2567
• DOI: 10.1007/s10875-006-9025-3

The present clinical study was designed to evaluate the efficacy, pharmacokinetics and safety of a new 10% liquid intravenous immune globulin in patients with primary immunodeficiency diseases. Sixty-one adults and children with primary immuno-deficiency diseases received doses of 300-600 mg/kg body weight every 21-28 days for 12 months. No validated acute serious bacterial infections were reported. The 95% confidence interval for the annualized rate of acute serious bacterial infections (primary endpoint) was 0-0.060. A total of four predefined validated other bacterial infections commonly occurring in primary immunodeficiency disease subjects were observed; none were serious, severe or resulted in hospitalization. The median elimination half-life of IgG was 35 days. Median total IgG trough levels varied from 9.6 to 11.2 g/L. Temporally associated adverse experiences were determined for 72 h after each infusion and the most common adverse experience was headache, which was associated with 6.9% of infusions. The study met the primary endpoint for efficacy and demonstrated excellent tolerability of the new 10% liquid intravenous imunoglobulin preparation.