Efficacy and safety of a new immunoglobulin G product, Gammaplex(®), in primary immunodeficiency diseases.
This open-label multi-centre study evaluated a new intravenous immunoglobulin, Gammaplex®, in the treatment of 50 patients with primary immunodeficiency and significant hypogammglobulinaemia. Patients treated previously with other intravenous immunoglobulins received Gammaplex® on their same infusion schedule for 1 year; 22 were on a 21-day and 28 on a 28-day regimen (300-800 mg/kg/infusion). There were no serious, acute bacterial infections, whereas six subjects (12·0%) had at least one such infection in the 6 months before enrollment. Forty subjects (80·0%) had at least one non-serious infection; the median number of infective episodes per subject per year was 3·07. Antibiotics were taken by 38 subjects therapeutically and prophylactically by 16 at some time. Fewer than half (46·0%) missed any time off work or school because of infection or other illness. Trough immunoglobulin (Ig)G levels were above 6·00 g/l in all subjects at all assessments after 15 weeks with two exceptions. Overall, 21·2% of infusions were associated with an adverse event up to 72 h after infusion. The frequency of adverse events increased with infusion rate. Headache was the most common product-related adverse event (7·5% of 703 infusions). In conclusion, Gammaplex® is effective in primary immunodeficiency and is well tolerated.
Rush University Medical Center, Chicago, IL, USA.
J N
JN
Moy
A M
AM
Scharenberg
M R
MR
Stein
D
D
Suez
R L
RL
Roberts
R J
RJ
Levy
M
M
Ballow
M B
MB
Fasano
C H
CH
Dash
S J
SJ
Leach
D000293:Adolescent; D000328:Adult; D000368:Aged; D002648:Child; D002985:Clinical Protocols; D017074:Common Variable Immunodeficiency / Q000188:drug therapy* / Q000453:epidemiology / Q000503:physiopathology; D005260:Female; D005334:Fever; D005500:Follow-Up Studies; D006760:Hospitalization; D006801:Humans; D016756:Immunoglobulins, Intravenous / Q000008:administration & dosage* / Q000009:adverse effects / Q000493:pharmacokinetics; D007239:Infections; D008297:Male; D008875:Middle Aged
D016756:Immunoglobulins, Intravenous