Efficacy and safety of a new 20% immunoglobulin preparation for subcutaneous administration, IgPro20, in patients with primary immunodeficiency.

Abstract

Subcutaneous human IgG (SCIG) therapy in primary immunodeficiency (PID) offers sustained IgG levels throughout the dosing cycle and fewer adverse events (AEs) compared to intravenous immunoglobulin (IVIG). A phase I study showed good local tolerability of IgPro20, a new 20% liquid SCIG stabilized with L-proline. A prospective, open-label, multicenter, single-arm, phase III study evaluated the efficacy and safety of IgPro20 in patients with PID over 15 months. Forty-nine patients (5-72 years) previously treated with IVIG received weekly subcutaneous infusions of IgPro20. The mean serum IgG level was 12.5 g/L. No serious bacterial infections were reported. There were 96 nonserious infections (rate 2.76/patient per year). The rate of days missed from work/school was 2.06/patient per year, and the rate of hospitalization was 0.2/patient per year. Ninety-nine percent of AEs were mild or moderate. No serious, IgPro20-related AEs were reported. IgPro20 effectively protected patients with PID against infections and maintained serum IgG levels without causing unexpected AEs.

• Authors: John B Hagan, Mary B Fasano, Sheldon Spector, Richard L Wasserman, Isaac Melamed, Mikhail A Rojavin, Othmar Zenker, Jordan S Orange
• Journal: Journal of clinical immunology (J Clin Immunol) Vol. 30 Issue 5 Pg. 734-45 (Sep 2010) ISSN: 1573-2592 [Electronic] Netherlands
• PMID: 20454851 (Publication Type: Clinical Trial, Phase I, Clinical Trial, Phase III, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Immunoglobulin G
• Immunoglobulins, Intravenous
• Immunologic Factors

Topics

• Adolescent
• Adult
• Agammaglobulinemia (blood, drug therapy, immunology, physiopathology)
• Aged
• Bacterial Infections (prevention & control)
• Child
• Common Variable Immunodeficiency (blood, drug therapy, immunology, physiopathology)
• Female
• Genetic Diseases, X-Linked (blood, drug therapy, immunology, physiopathology)
• Humans
• Immunoglobulin G (blood)
• Immunoglobulins, Intravenous (therapeutic use)
• Immunologic Factors (administration & dosage, adverse effects, therapeutic use)
• Injections, Subcutaneous
• Male
• Middle Aged
• Prospective Studies
• Protein Stability