A multicenter, prospective, open label, historically controlled clinical trial to evaluate efficacy and safety in Primary Immunodeficiency Diseases (PID) patients of Flebogamma® 5% DIF, the next generation of Flebogamma®

Background: Flebogamma® 5% dual inactivation and filtration (DIF) is the next generation of Flebogamma®. Flebogamma® was first licensed in 1992. The new preparation features additional viral inactivation and removal steps to enhance safety margins. Objective: The purpose of this study was to evaluate the efficacy, safety, and pharmacokinetics of Flebogamma® 5% DIF for immunoglobulin replacement therapy in primary immunodeficiency diseases (PID). Methods: Flebogamma® 5% DIF was administered at seven clinical sites to 46 subjects with well-defined primary immunodeficiency diseases at a dose of 300-600 mg/kg every 21-28 days for 12 months. Results: The calculated serious bacterial infection rate was 0.021/subject/year. The incidence of adverse events considered potentially related to Flebogamma® 5% DIF during or within 72 h after completing an infusionwas approximately 10%. The half-life in serum of the administered IgG was around 31 days. Conclusions: Flebogamma® 5% DIF is efficacious and safe, has adequate pharmacokinetic properties, is well-tolerated and maintains the profile of Flebogamma® 5% for the treatment of primary humoral immunodeficiency diseases.