A pilot study of equal doses of 10% IGIV given intravenously or subcutaneously.

摘要

Patients with primary immunodeficiency disease are most often given immunoglobulin replacement therapy by the intravenous route. Subcutaneous administration offers advantages that may be important for many patients. Because of differences in the pharmacokinetics of IgG given by the subcutaneous versus intravenous route, the Food and Drug Administration required that the area under the curve of serum IgG versus time must be noninferior for IgG given by the subcutaneous compared with the intravenous route.In contrast, European regulators require only that the trough serum IgG levels maintained on steady-state subcutaneous therapy must be higher than those achieved with intravenous therapy given every 3 to 4 weeks.