TY - JOUR
T1 - Comparison of the efficacy of IGIV-C, 10% (caprylate/chromatography) and IGIV-SD, 10% as replacement therapy in primary immune deficiency
T2 - A randomized double-blind trial
AU - Roifman, Chaim M.
AU - Schroeder, Harry
AU - Berger, Melvin
AU - Sorensen, Ricardo
AU - Ballow, Mark
AU - Buckley, Rebecca H.
AU - Gewurz, Anita
AU - Korenblat, Phillip
AU - Sussman, Gordon
AU - Lemm, Georg
AU - Stein, Mark
AU - Stark, Donald
AU - Ermitano, Maria Louisa
AU - Desroches, Anne
AU - Mazer, Bruce
AU - Church, Joseph
AU - Ballas, Zuhair
AU - Filipovich, Alexandra
AU - Friday, Gilbert
AU - Graffino, Donatella
AU - Haysman, Melvin
AU - Knutsen, Alan
AU - Richmond, Wendel
AU - Rubinstein, Arye
AU - Marquinez, Frederick
AU - McNeil, Don
AU - Skoda-Smith, Susanne
N1 - Funding Information:
This study (Identifier 100175) was funded by Bayer Healthcare, Biological Product Division, Research Triangle Park, NC, as part of the clinical development of Gamunex™, 10%.
PY - 2003/9
Y1 - 2003/9
N2 - 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.
AB - 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.
KW - IGIV
KW - IVIG
KW - IgG
KW - Immunoglobulin
KW - Immunotherapy
KW - Primary immunodeficiency
KW - Sinopulmonary infection
KW - Sinusitis
KW - Viral safety
UR - http://www.scopus.com/inward/record.url?scp=10744229712&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=10744229712&partnerID=8YFLogxK
U2 - 10.1016/S1567-5769(03)00134-6
DO - 10.1016/S1567-5769(03)00134-6
M3 - Article
C2 - 12890430
AN - SCOPUS:10744229712
SN - 1567-5769
VL - 3
SP - 1325
EP - 1333
JO - International Immunopharmacology
JF - International Immunopharmacology
IS - 9
ER -