Efficacy and Safety of the New Intravenous Immunoglobulin IGIV 10% in Adults with Chronic Idiopathic Thrombocytopenic Purpura

Abstract

Background: Intravenous immunoglobulin (IGIV) 10% is a newly developed10% liquid immunoglobulin preparation for intravenous use where 3 dedicatedvirus reduction steps have been integrated into the manufacturingprocess. The efficacy and safety of this product were assessed in a prospectivemulticenter study in chronic ITP (idiopathic thrombocytopenic purpura)patients with platelet counts of =20 × 109/l. Patients and Methods: 23 adult ITPpatients received the product at a total dose of 2 g/kg body weight administeredover 2-5 days, and were followed for 4 weeks. Results: Of the 21 subjectsincluded in the Per-Protocol Analysis Data Set, 15 responded successfullyto treatment (71.4%). Eleven subjects in this group attained a platelet countincrease to >100 × 109/l, and 8 reached a platelet count of >200 × 109/l. All 15responders achieved a platelet count of =50 × 109/l by day 8, and 14 of themreached this level by day 5. The median duration of platelet response was 25days, and the highest median platelet count in the responders was 182 × 109/l.A total of 81 infusions were administered to the 23 subjects in the SafetyAnalysis Data Set over the course of the study. There were 40 non-serious adverseevents related to the use of the study drug - 35 mild, 3 moderate, and2 severe. The most frequent related adverse events were headache andpyrexia. Conclusion: The results obtained in this study demonstrate that IGIV10% is effective in the treatment of adult subjects with chronic ITP and indicatea good safety profile.