Borhane Slama1, Olivier Fain2, Hervé Maisonneuve3, Eric Jourdan4, Jean-François Viallard5, Rabye Ouaja6, Ousmane Alfa-Cissé6, Bertrand Godeau7. 1. Department of Haematology, Henri Duffaut Hospital France. 2. Department of Internal Medicine, Jean Verdier Hospital France. 3. Department of Internal Medicine, Les Oudairies Hospital France. 4. Hematology Department, Carémeau Hospital France. 5. Department of Internal Medicine, Haut-Lévêque Hospital France. 6. Global Scientific Affairs Unit, LFB Biomedicaments France. 7. Department of Internal Medicine, University Hospital Henri Mondor France.
Abstract
PURPOSE: The present study was designed to assess the efficacy and safety of IGNG that is a new liquid, saccharose and maltose-free highly purified ready-to-use 5% intravenous immunoglobulin (IVIg), in primary immune thrombocytopenic patients with severe thrombocytopenia. METHODS: Nineteen adults with a platelet count ≤ 25 × 109/L received a single dose of IGNG (1 g/kg) on Day 1, with a second identical dose on Day 3 if needed. Patients were followed for 30 days. Primary endpoint was the response rate, defined as the proportion of patients with a platelet count ≥ 50 × 109/L within 96 hours after the first IGNG dose. RESULTS: All but one of the 17 evaluable patients for efficacy responded with an overall response rate of 94.1% (95% CI 71.3%-99.9%). Response was observed after only one infusion (1 g/kg boby weight) in 11 patients (59%) and the others required a second dose. Mean time to response was 2.2 days. Maximum platelet count was reached within 1 week after the first dose and lasted for approximately 2 weeks. Patients requiring a second dose had lower platelet counts at baseline than patients requiring a single dose. In the 19 evaluable patients for safety, IGNG demonstrated good safety, good hepatic and renal tolerance, and did not induce hemolysis. This trial was registered at the French Medical Agency (AFSSAPS) as #DI n°060735.
PURPOSE: The present study was designed to assess the efficacy and safety of IGNG that is a new liquid, saccharose and maltose-free highly purified ready-to-use 5% intravenous immunoglobulin (IVIg), in primary immune thrombocytopenicpatients with severe thrombocytopenia. METHODS: Nineteen adults with a platelet count ≤ 25 × 109/L received a single dose of IGNG (1 g/kg) on Day 1, with a second identical dose on Day 3 if needed. Patients were followed for 30 days. Primary endpoint was the response rate, defined as the proportion of patients with a platelet count ≥ 50 × 109/L within 96 hours after the first IGNG dose. RESULTS: All but one of the 17 evaluable patients for efficacy responded with an overall response rate of 94.1% (95% CI 71.3%-99.9%). Response was observed after only one infusion (1 g/kg boby weight) in 11 patients (59%) and the others required a second dose. Mean time to response was 2.2 days. Maximum platelet count was reached within 1 week after the first dose and lasted for approximately 2 weeks. Patients requiring a second dose had lower platelet counts at baseline than patients requiring a single dose. In the 19 evaluable patients for safety, IGNG demonstrated good safety, good hepatic and renal tolerance, and did not induce hemolysis. This trial was registered at the French Medical Agency (AFSSAPS) as #DI n°060735.
Authors: Bertrand Godeau; Sylvie Chevret; Bruno Varet; François Lefrère; Jean Marc Zini; François Bassompierre; Stéphane Chèze; Eric Legouffe; Cyrille Hulin; Marie José Grange; Olivier Fain; Philippe Bierling Journal: Lancet Date: 2002-01-05 Impact factor: 79.321
Authors: W Marieke Schoonen; Gena Kucera; Jenna Coalson; Lin Li; Mark Rutstein; Fionna Mowat; Jon Fryzek; James A Kaye Journal: Br J Haematol Date: 2009-02-24 Impact factor: 6.998