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

J Clin Immunol. 2010 Sep;30(5):734-45. doi: 10.1007/s10875-010-9423-4. Epub 2010 May 8.

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.

Publication types

  • Clinical Trial, Phase I
  • Clinical Trial, Phase III
  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

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

Substances

  • Immunoglobulin G
  • Immunoglobulins, Intravenous
  • Immunologic Factors

Supplementary concepts

  • Bruton type agammaglobulinemia