Efficacy and Safety of a New Intravenous Immunoglobulin in Adult Subjects with Chronic Idiopathic Thrombocytopenic Purpura.

Idiopathic thrombocytopenic purpura (ITP) is a common clinical disorder of immune regulation leading to phagocytic destruction of platelets. Intravenous immunoglobulin (IGIV) has been used successfully to increase platelet count in patients with ITP. Baxter has developed a new IGIV (IGIV,10%), a 10% liquid immunoglobulin preparation with 3 dedicated virus reduction steps integrated into the manufacturing process. The efficacy and safety of this product was assessed in a prospective multi-center study in adult chronic ITP patients with platelet counts of 20x10⁹/L or less. A total of 23 subjects were enrolled and treated for 2 to 5 days with a total dose of 2 g/kg. Of 21 subjects included in the per-protocol analysis data set, 15 responded to treatment (71.4%), achieving a platelet count of at least 50x10⁹/L by Day 8. Fourteen of 15 responders reached this level by Day 5. The median duration of platelet response was 25 days and the highest median platelet count in the responders was 182x10⁹/L. A total of 81 infusions were administered to the 23 subjects in the safety analysis data set. Among the 40 non-serious adverse events related to the use of the study drug, 35 were mild, 3 were moderate, and 2 were severe. The most frequent related adverse events were headache and pyrexia. The results of this study demonstrate that IGIV, 10% TVR Solution is effective in the treatment of adult subjects with chronic ITP and has an excellent safety profile.