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


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.


CONCLUSIONS
Privigen is well tolerated and effective for the treatment of primary immunodeficiency.
Stein
Mark R
MR
Allergy Associates of the Palm Beaches, 840 US Highway 1, Suite 235, North Palm Beach, FL 33408, USA. latallergy@aol.com
Nelson
Robert P
RP
Church
Joseph A
JA
Wasserman
Richard L
RL
Borte
Michael
M
Vermylen
Christiane
C
Bichler
Johann
J
D000293:Adolescent; D000328:Adult; D000368:Aged; D002648:Child; D002675:Child, Preschool; D005260:Female; D006801:Humans; D007074:Immunoglobulin G / Q000097:blood; D016756:Immunoglobulins, Intravenous / Q000008:administration & dosage* / Q000009:adverse effects; D007153:Immunologic Deficiency Syndromes / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D055815:Young Adult
D007074:Immunoglobulin G; D016756:Immunoglobulins, Intravenous