Safety and Efficacy of PrivigenA (R), a Novel 10% Liquid Immunoglobulin Preparation for Intravenous Use, in Patients with Primary Immunodeficiencies

The present study was designed to evaluate the efficacy and safety of a novel, 10% liquid formulation of intravenous immunoglobulin, stabilized with 250 mmol/L l-proline (PrivigenA (R)), in patients with primary immunodeficiency disease. Eighty adults and children diagnosed with common variable immunodeficiency or X-linked agammaglobulinemia received intravenous PrivigenA (R) infusions (200-888 mg/kg) at 3- or 4-week intervals over a 12-month period, according to their previously established maintenance dose. The primary endpoint was the annual rate of acute serious bacterial infections. There were six episodes of acute serious bacterial infections, corresponding to an annual rate of 0.08; the annual rate for all infections was 3.55. Mean serum IgG trough levels were between 8.84 and 10.27 g/L. A total of 1,038 infusions were administered, most of them at the maximum rate permitted (8.0 mg kg(-1) min(-1)). Temporally associated adverse events, possibly or probably related to study drug, occurred in 9% of infusions, either during or within 72 h after infusion end. PrivigenA (R) is well tolerated and effective for the treatment of primary immunodeficiency.