Safety and efficacy of Privigen, a novel 10% liquid immunoglobulin preparation for intravenous use, in patients with primary immunodeficiencies.

Abstract

PURPOSE:

The present study was designed to evaluate the efficacy and safety of a novel, 10% liquid formulation of intravenous immunoglobulin, stabilized with 250 mmol/L L-proline (Privigen), in patients with primary immunodeficiency disease.

MATERIALS AND METHODS:

Eighty adults and children diagnosed with common variable immunodeficiency or X-linked agammaglobulinemia received intravenous Privigen infusions (200-888 mg/kg) at 3- or 4-week intervals over a 12-month period, according to their previously established maintenance dose. The primary endpoint was the annual rate of acute serious bacterial infections.

RESULTS:

There were six episodes of acute serious bacterial infections, corresponding to an annual rate of 0.08; the annual rate for all infections was 3.55. Mean serum IgG trough levels were between 8.84 and 10.27 g/L. A total of 1,038 infusions were administered, most of them at the maximum rate permitted (8.0 mg kg(-1) min(-1)). Temporally associated adverse events, possibly or probably related to study drug, occurred in 9% of infusions, either during or within 72 h after infusion end.

CONCLUSION:

Privigen is well tolerated and effective for the treatment of primary immunodeficiency.

• Authors: Mark R Stein, Robert P Nelson, Joseph A Church, Richard L Wasserman, Michael Borte, Christiane Vermylen, Johann Bichler, IgPro10 in PID study group
• Journal: Journal of clinical immunology (J Clin Immunol) Vol. 29 Issue 1 Pg. 137-44 (Jan 2009) ISSN: 1573-2592 [Electronic] Netherlands
• PMID: 18814020 (Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)

Chemical References

• Immunoglobulin G
• Immunoglobulins, Intravenous

Topics

• Adolescent
• Adult
• Aged
• Child
• Child, Preschool
• Female
• Humans
• Immunoglobulin G (blood)
• Immunoglobulins, Intravenous (administration & dosage, adverse effects)
• Immunologic Deficiency Syndromes (drug therapy)
• Male
• Middle Aged
• Young Adult