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 developed 10% liquid immunoglobulin preparation for intravenous use where 3 dedicated virus reduction steps have been integrated into the manufacturing process. The efficacy and safety of this product were assessed in a prospective multicenter study in chronic ITP (idiopathic thrombocytopenic purpura) patients with platelet counts of =20 × 109/l. Patients and Methods: 23 adult ITP patients received the product at a total dose of 2 g/kg body weight administered over 2-5 days, and were followed for 4 weeks. Results: Of the 21 subjects included in the Per-Protocol Analysis Data Set, 15 responded successfully to treatment (71.4%). Eleven subjects in this group attained a platelet count increase to >100 × 109/l, and 8 reached a platelet count of >200 × 109/l. All 15 responders achieved a platelet count of =50 × 109/l by day 8, and 14 of them 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 182 × 109/l. A total of 81 infusions were administered to the 23 subjects in the Safety Analysis Data Set over the course of the study. There were 40 non-serious adverse events related to the use of the study drug - 35 mild, 3 moderate, and 2 severe. The most frequent related adverse events were headache and pyrexia. Conclusion: The results obtained in this study demonstrate that IGIV 10% is effective in the treatment of adult subjects with chronic ITP and indicate a good safety profile.

Human Immunoglobulin (KIOVIG ® /GAMMAGARD LIQUID ® ) for Immunodeficiency and Autoimmune Diseases: An Observational Cohort Study

“…The infusion rate of IVIG 10% used in subjects with immunodeficiency (median maximum: 3.02 ml/kg BW/h) was well below the recommended maximum rate. With respect to the treatment of autoimmune disease, the median total dose of IVIG 10% was as expected (1.7-1.9 g/kg BW), and for ITP, was comparable to that administered in a prior clinical study of IVIG 10% in ITP (2.00 g/kg BW) [23]. Compared to the infusion rate used in subjects with immunodeficiency, IVIG 10% was infused more slowly (median maximum flow rate: 1.89 ml/ kg BW/h) in subjects with autoimmune disease, in whom prior exposure to Ig concentrates was presumably uncommon.…”

“…All but one subject attained platelet counts >50 × 10 9 /l within a median of 3 days after initiating treatment, in contrast to 71.4% of subjects who did so within 15 days in a previously reported clinical study on the same Ig preparation [23]. The higher response rate documented in the present study may be attributed to the acute subtype of ITP that was diagnosed in all subjects, while in the earlier study all subjects had chronic ITP, which in some subjects becomes refractory to treatment [23]. Intravenous Ig is a standard first-line treatment of Kawasaki disease based on the demonstration of efficacy in previous clinical studies [30].…”

Clinical efficacy and safety of Flebogammadif®, a new high‐purity human intravenous immunoglobulin, in adult patients with chronic idiopathic thrombocytopenic purpura

“…Furthermore, our work is the first clinical study, which supports the efficacy of Flebogammadif ® with regard to immunomodulatory activities such as the treatment of patients with chronic ITP. The data on clinical efficacy reported in the literature indicate that the response to IVIG in patients with ITP may vary depending on the product tested, the dosing mode or the study design (Choi et al , 2001, Wolf et al , 2003, Varga et al , 2006). Treatment with IVIG is effective and the platelet response rates reported range from 66 to 100% (Korninger et al , 1985, Wolf et al , 2003).…”

Relevant Criteria for Selecting an Intravenous Immunoglobulin Preparation for Clinical Use

“…The efficacy of IVIg as replacement therapy [44,[74][75][76] or as immunomodulatory or anti-inflammatory therapy [44,[77][78][79] is well established. IVIg products are approved for use in at least six disease entities in US and EU, [2,6,7] and are probably beneficial in more than ten off-label indications.…”