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

Mark R. Stein, Robert Nelson, Joseph A. Church, Richard L. Wasserman, Michael Borte, Christiane Vermylen, Johann Bichler

Research output: Contribution to journalArticle

62 Citations (Scopus)

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.

Original languageEnglish (US)
Pages (from-to)137-144
Number of pages8
JournalJournal of Clinical Immunology
Volume29
Issue number1
DOIs
StatePublished - Jan 2009

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Intravenous Immunoglobulins
Safety
Bacterial Infections
Common Variable Immunodeficiency
Intravenous Infusions
Proline
Immunoglobulin G
Infection
Serum
Pharmaceutical Preparations
Therapeutics

Keywords

  • Common variable immunodeficiency (CVID)
  • Intravenous immunoglobulin (IVIG)
  • Primary immunodeficiency (PID)
  • X-linked agammaglobulinemia (XLA)

ASJC Scopus subject areas

  • Immunology and Allergy
  • Immunology

Cite this

Safety and efficacy of Privigen®, a novel 10% liquid immunoglobulin preparation for intravenous use, in patients with primary immunodeficiencies. / Stein, Mark R.; Nelson, Robert; Church, Joseph A.; Wasserman, Richard L.; Borte, Michael; Vermylen, Christiane; Bichler, Johann.

In: Journal of Clinical Immunology, Vol. 29, No. 1, 01.2009, p. 137-144.

Research output: Contribution to journalArticle

Stein, Mark R. ; Nelson, Robert ; Church, Joseph A. ; Wasserman, Richard L. ; Borte, Michael ; Vermylen, Christiane ; Bichler, Johann. / Safety and efficacy of Privigen®, a novel 10% liquid immunoglobulin preparation for intravenous use, in patients with primary immunodeficiencies. In: Journal of Clinical Immunology. 2009 ; Vol. 29, No. 1. pp. 137-144.
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