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Efficacy and Safety of a New 20% Immunoglobulin Preparation for Subcutaneous Administration, IgPro20, in Patients With Primary Immunodeficiency
Journal article   Open access   Peer reviewed

Efficacy and Safety of a New 20% Immunoglobulin Preparation for Subcutaneous Administration, IgPro20, in Patients With Primary Immunodeficiency

John B Hagan, Mary B Fasano, Sheldon Spector, Richard L Wasserman, Isaac Melamed, Mikhail A Rojavin, Othmar Zenker and Jordan S Orange
Journal of clinical immunology, Vol.30(5), pp.734-745
09/2010
DOI: 10.1007/s10875-010-9423-4
PMCID: PMC2935975
PMID: 20454851
url
https://doi.org/10.1007/s10875-010-9423-4View
Published (Version of record) Open Access

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.
 serum IgG trough levels Subcutaneous immunoglobulin (SCIG) primary immunodeficiency home infusion therapy local tolerability L-proline

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