Safety and efficacy of self-administered subcutaneous immunoglobulin in patients with primary immunodeficiency diseases.

摘要: Intravenous immunoglobulin (IVIg) infusions at 3-4 week intervals are currently standard therapy in the United States for patients with primary immune deficiency diseases (PIDD). To evaluate alternative modes of administration we have designed an open-label study to investigate efficacy and safety a subcutaneously administered preparation (16% IgG) PIDD. After their final IVIg infusion, 65 entered 3-month, wash-in/wash-out phase, bring steady-state immunoglobulin. This was followed by 12 months weekly SCIg infusions, dose determined pharmacokinetic substudy provide noninferior intravascular exposure. resulted mean 158 mg/kg, calculated equal 137% previous intravenous dose. Two (4%) each reported 1 serious bacterial infection (pneumonia), annual rate 0.04 per patient-year. There were 4.43 infections any type Mean trough serum IgG levels increased from 786 1040 mg/dL during study, increase 39%. The most frequent treatment-related adverse event infusion-site reaction, 91% patients; this predominantly mild or moderate, incidence decreased over time. No events reported. We conclude that subcutaneous 16% is safe effective replacement