Efficacy, safety and tolerability of a new 10% liquid intravenous immune globulin [IGIV 10%] in patients with primary immunodeficiency.
The present clinical study was designed to evaluate the efficacy, pharmacokinetics and safety of a new 10% liquid intravenous immune globulin in patients with primary immunodeficiency diseases. Sixty-one adults and children with primary immuno-deficiency diseases received doses of 300-600 mg/kg body weight every 21-28 days for 12 months. No validated acute serious bacterial infections were reported. The 95% confidence interval for the annualized rate of acute serious bacterial infections (primary endpoint) was 0-0.060. A total of four predefined validated other bacterial infections commonly occurring in primary immunodeficiency disease subjects were observed; none were serious, severe or resulted in hospitalization. The median elimination half-life of IgG was 35 days. Median total IgG trough levels varied from 9.6 to 11.2 g/L. Temporally associated adverse experiences were determined for 72 h after each infusion and the most common adverse experience was headache, which was associated with 6.9% of infusions. The study met the primary endpoint for efficacy and demonstrated excellent tolerability of the new 10% liquid intravenous imunoglobulin preparation.
Church
Joseph A
JA
Childrens Hospital Los Angeles, Los Angeles, California, USA.
Leibl
Heinz
H
Stein
Mark R
MR
Melamed
Isaac R
IR
Rubinstein
Arye
A
Schneider
Lynda C
LC
Wasserman
Richard L
RL
Pavlova
Borislava G
BG
Birthistle
Karl
K
Mancini
Marianne
M
Fritsch
Sandor
S
Patrone
Lisa
L
Moore-Perry
Kerry
K
Ehrlich
Hartmut J
HJ
D000293:Adolescent; D000328:Adult; D000368:Aged; D001424:Bacterial Infections / Q000139:chemically induced; D002648:Child; D005260:Female; D006261:Headache / Q000139:chemically induced; D006801:Humans; D016756:Immunoglobulins, Intravenous / Q000008:administration & dosage* / Q000493:pharmacokinetics / Q000633:toxicity; D007153:Immunologic Deficiency Syndromes / Q000150:complications / Q000188:drug therapy*; D007167:Immunotherapy / Q000009:adverse effects / Q000379:methods; D015994:Incidence; D008297:Male; D008875:Middle Aged; D010599:Pharmacokinetics
D016756:Immunoglobulins, Intravenous