TY - JOUR
T1 - Efficacy and safety of a new 20% immunoglobulin preparation for subcutaneous administration, IgPro20, in patients with primary immunodeficiency
AU - Hagan, John B.
AU - Fasano, Mary B.
AU - Spector, Sheldon
AU - Wasserman, Richard L.
AU - Melamed, Isaac
AU - Rojavin, Mikhail A.
AU - Zenker, Othmar
AU - Orange, Jordan S.
N1 - Funding Information:
The authors thank Dr. Christian Peters for his help during the conduct of the study, and Dr. Andrea Sebald and Dr. Martin Bexon for critical review of the manuscript. The assistance of Fritz Schindel, Corina Miede, and Cordula Massion from Accovion GmbH for the statistical analyses is gratefully appreciated. We also acknowledge the editorial assistance of Phocus Services Ltd supported by CSL Behring.
Funding Information:
Acknowledgements This study was supported by CSL Behring LLC, King of Prussia, PA. The opinions expressed in this paper are those of the authors.
PY - 2010/9
Y1 - 2010/9
N2 - 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.
AB - 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.
KW - L-proline
KW - Subcutaneous immunoglobulin (SCIG)
KW - home infusion therapy
KW - local tolerability
KW - primary immunodeficiency
KW - serum IgG trough levels
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U2 - 10.1007/s10875-010-9423-4
DO - 10.1007/s10875-010-9423-4
M3 - Article
C2 - 20454851
AN - SCOPUS:77957580751
SN - 0271-9142
VL - 30
SP - 734
EP - 745
JO - Journal of Clinical Immunology
JF - Journal of Clinical Immunology
IS - 5
ER -