Journal article
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, Vol.3(9), pp.1325-1333
2003
DOI: 10.1016/S1567-5769(03)00134-6
PMID: 12890430
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.
Details
- Title: Subtitle
- 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
- Creators
- Chaim M Roifman - Hospital for Sick ChildrenHarry Schroeder - University of Alabama at BirminghamMelvin Berger - University Hospitals of ClevelandRicardo Sorensen - Louisiana State University Health Sciences Center New OrleansMark Ballow - Women & Children's Hospital of BuffaloRebecca H Buckley - Duke UniversityAnita Gewurz - Rush University Medical CenterPhillip KorenblatGordon Sussman - The Wellesley Central Hospital, Toronto, ON, CanadaGeorg Lemm - BayerIGIV-C in PID Study Group
- Contributors
- Zuhair Ballas (Contributor) - University of Iowa, Immunology
- Resource Type
- Journal article
- Publication Details
- International immunopharmacology, Vol.3(9), pp.1325-1333
- Publisher
- Elsevier B.V
- DOI
- 10.1016/S1567-5769(03)00134-6
- PMID
- 12890430
- ISSN
- 1567-5769
- eISSN
- 1878-1705
- Language
- English
- Date published
- 2003
- Academic Unit
- Immunology; Internal Medicine
- Record Identifier
- 9984359944402771
Metrics
6 Record Views