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Clinical Trial
. 2010 Dec;162(3):510-5.
doi: 10.1111/j.1365-2249.2010.04247.x.

Efficacy and safety of a new immunoglobulin G product, Gammaplex(®), in primary immunodeficiency diseases

J N Moy  1 , A M Scharenberg, M R Stein, D Suez, R L Roberts, R J Levy, M Ballow, M B Fasano, C H Dash, S J Leach
Affiliations
Clinical Trial

Efficacy and safety of a new immunoglobulin G product, Gammaplex(®), in primary immunodeficiency diseases

J N Moy et al. Clin Exp Immunol. 2010 Dec.

Abstract

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.

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Figures

Fig. 1
Fig. 1
Number of school/work days missed because of infection or illness. *This subject underwent lumbar disc surgery, experienced recurrent wheezing and had a coincidental squamous cell carcinoma (240 days off school/work).
Fig. 2
Fig. 2
Concentrations of immunoglobulin (Ig)G against time in patients who received mean 467 mg/kg Gammaplex® administered on a 21-day or 28-day schedule. Results shown as mean ± standard deviation; n = 9 for the 21-day schedule and n = 15 for the 28-day schedule.
See this image and copyright information in PMC

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