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, Jordan S. Orange

Research output: Contribution to journalArticlepeer-review

95 Scopus citations

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.

Original languageEnglish (US)
Pages (from-to)734-745
Number of pages12
JournalJournal of Clinical Immunology
Volume30
Issue number5
DOIs
StatePublished - Sep 2010

Keywords

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

ASJC Scopus subject areas

  • Immunology and Allergy
  • Immunology

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