Rapid subcutaneous immunoglobulin administration every second week results in high and stable serum immunoglobulin G levels in patients with primary antibody deficiencies

Clinical and Experimental Immunology - Tập 152 Số 2 - Trang 274-279 - 2008
R Gustafson1,2, Ann Gardulf3, Susanne Vinkel Koch2, Heinz Leibl4, Werner Engl4, Magdalena Lindén2, Anne Müller4, Lennart Hammarström3
1Baxter Medical AB, Kista
2Immunodeficiency Unit, Karolinska University Hospital, Huddinge, Stockholm
3Department of Laboratory Medicine, Division of Clinical Immunology, Karolinska Institutet at Karolinska University Hospital, Huddinge, Stockholm, Sweden
4Baxter AG, Vienna, Austria

Tóm tắt

Summary Subcutaneous immunoglobulin G (SCIG) infusions as life-long replacement therapy in patients with primary antibody deficiences (PAD) is being applied increasingly. However, only a few published pharmacokinetic studies are available for this route of administration. Therefore, the pharmacokinetics of a 16% immunoglobulin G (IgG) preparation intended for subcutaneous use were investigated in patients with common variable immunodeficiency and X-linked agammaglobulinaemia. SCIG infusions (200 mg/kg body weight) were administered to 12 adult patients every 14 days for 24 weeks (total of 144 infusions). Pharmacokinetic parameters were determined based on serum IgG trough levels and antibody levels against tetanus. The median half-life of the total serum IgG and for the tetanus antibodies was 40·6 and 23·3 days respectively. Median in vivo recovery of serum IgG and tetanus immunoglobulins were 36% and 46% respectively. Median, preinfusion serum IgG trough levels per patient were high without major variations between infusions and ranged from 7·24 to 7·86 g/l. Safety, in terms of adverse events including systemic adverse reactions and local tissue reactions at infusions sites, was monitored throughout the study. Six mild, local tissue reactions were observed during the study in one patient. No systemic adverse reactions related to the study drug were observed and no serious other adverse event occurred during the study. It is concluded that the bi-weekly SCIG therapy was well tolerated in the study and that it results in high and stable serum IgG levels, offering an alternative therapy regimen to patients suffering from PAD.

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Tài liệu tham khảo

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Thông tin xuất bản

Clinical and Experimental Immunology

Tập 152 Số 2

274-279

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