Comparison of the efficacy of IGIV-C, 10% (caprylate/chromatography) and IGIV-SD, 10% as replacement therapy in primary immune deficiency: A randomized double-blind trial

Chaim M. Roifman, Harry Schroeder, Melvin Berger, Ricardo Sorensen, Mark Ballow, Rebecca H. Buckley, Anita Gewurz, Phillip Korenblat, Gordon Sussman, Georg Lemm, Mark Stein, Donald Stark, Maria Louisa Ermitano, Anne Desroches, Bruce Mazer, Joseph Church, Zuhair Ballas, Alexandra Filipovich, Gilbert Friday, Donatella GraffinoMelvin Haysman, Alan Knutsen, Wendel Richmond, Arye Rubinstein, Frederick Marquinez, Don McNeil, Susanne Skoda-Smith

Research output: Contribution to journalArticle

103 Scopus citations

Abstract

A novel method of large-scale chromatography has been developed to improve recovery and purity of immunoglobulin G (IgG) from pooled plasma. The current study compares safety, toxicity and efficacy of two intravenous immunoglobulin products: a novel formulation, IGIV caprylate/chromatography (IGIV-C; Gamunex™, 10%) and a licensed solvent/detergent-treated product, Gamimune®N, 10% (IGIV-SD). The study, a randomized, double-blind, parallel group, therapeutic equivalence trial, was conducted at 25 treatment centers in Canada and the United States. Patients (n=172) having confirmed chronic primary immunodeficiency (PID), aged 1-75 years, and receiving IGIV therapy were enrolled. For 9 months, patients were treated with IGIV-C or IGIV-SD in accordance with the patient's individualized treatment regimen utilized before study entry. The primary endpoint was the proportion of patients with ≥1 validated acute sinopulmonary infection during the treatment period. Secondary endpoints included the proportion of patients with all infections, time to first infection, annual infection rates, lung function parameters, infusion-related safety and viral safety. The annual validated infection rate in the IGIV-C group was 0.18 compared to 0.43 in the IGIV-SD group (p=0.023). Nine patients receiving IGIV-C experienced validated infections, compared to 17 patients in IGIV-SD group (p=0.06). Acute sinusitis (validated plus clinically defined) was less frequent in the IGIV-C group (p=0.012). Presence of bronchiectasis did not affect efficacy. Adverse reactions were similar in frequency and severity in both groups. No evidence of viral transmission was observed. IGIV-C appears to be superior to IGIV-SD in preventing validated sinopulmonary infections, especially acute sinusitis, in patients with PID.

Original languageEnglish (US)
Pages (from-to)1325-1333
Number of pages9
JournalInternational Immunopharmacology
Volume3
Issue number9
DOIs
StatePublished - Sep 2003

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Keywords

  • IGIV
  • IVIG
  • IgG
  • Immunoglobulin
  • Immunotherapy
  • Primary immunodeficiency
  • Sinopulmonary infection
  • Sinusitis
  • Viral safety

ASJC Scopus subject areas

  • Immunology and Allergy
  • Immunology
  • Pharmacology

Cite this

Roifman, C. M., Schroeder, H., Berger, M., Sorensen, R., Ballow, M., Buckley, R. H., Gewurz, A., Korenblat, P., Sussman, G., Lemm, G., Stein, M., Stark, D., Ermitano, M. L., Desroches, A., Mazer, B., Church, J., Ballas, Z., Filipovich, A., Friday, G., ... Skoda-Smith, S. (2003). Comparison of the efficacy of IGIV-C, 10% (caprylate/chromatography) and IGIV-SD, 10% as replacement therapy in primary immune deficiency: A randomized double-blind trial. International Immunopharmacology, 3(9), 1325-1333. https://doi.org/10.1016/S1567-5769(03)00134-6