Efficacy and Safety of a New 20% Immunoglobulin Preparation for Subcutaneous Administration, IgPro20, in Patients With Primary Immunodeficiency

摘要: Subcutaneous human IgG (SCIG) therapy in primary immunodeficiency (PID) offers sustained levels throughout the dosing cycle and fewer adverse events (AEs) compared to intravenous immunoglobulin (IVIG). A phase I study showed good local tolerability of IgPro20, a new 20% liquid SCIG stabilized with L-proline. prospective, open-label, multicenter, single-arm, III evaluated efficacy safety IgPro20 patients PID over 15 months. Forty-nine (5–72 years) previously treated IVIG received weekly subcutaneous infusions IgPro20. The mean serum level was 12.5 g/L. No serious bacterial infections were reported. There 96 nonserious (rate 2.76/patient per year). rate days missed from work/school 2.06/patient year, hospitalization 0.2/patient year. Ninety-nine percent AEs mild or moderate. serious, IgPro20-related effectively protected against maintained without causing unexpected AEs.