Safety and efficacy of intravenous immunoglobulin (Flebogamma® 10% DIF) in patients with immune thrombocytopenic purpura
Shashikant Apte, Jordi Navarro-Puerto, Sharat Damodar, Vijay Ramanan, Joseph John, Giraldo Kato, Cecil Ross, Chirag Shah, Marcela Torres, Chieh-Lin 'Kathy' Fu, Karen Rucker, Paul Pinciaro, Gladis Barrera, Maria Esperança Aragonés, Jaume Ayguasanosa, Shashikant Apte, Jordi Navarro-Puerto, Sharat Damodar, Vijay Ramanan, Joseph John, Giraldo Kato, Cecil Ross, Chirag Shah, Marcela Torres, Chieh-Lin 'Kathy' Fu, Karen Rucker, Paul Pinciaro, Gladis Barrera, Maria Esperança Aragonés, Jaume Ayguasanosa
Abstract
Aim: To evaluate the safety and efficacy of 10% intravenous immunoglobulin (IVIG; Flebogamma® 10% DIF) in individuals with chronic immune thrombocytopenic purpura (ITP).
Patients & methods: Patients aged 3-70 years, diagnosed with chronic ITP, received 1 g/kg IVIG over two consecutive days.
Results: 64 evaluable patients (51 adults, 13 children) with chronic ITP received IVIG. The primary efficacy end point (increased platelet counts from ≤20 × 109/l to ≥50 × 109/l by day 8) was achieved by 81.3% of patients; mean time to response was 1.7 days (all responders). Adverse events, mostly mild or moderate, were reported in 59 patients (92.2%).
Conclusion: Flebogamma® 10% DIF administered over two consecutive days was safe and effective in adults and children with chronic ITP.
Trial registration: ClinicalTrials.gov NCT00511147.
Keywords: Flebogamma DIF; ITP; hemorrhage; immune thrombocytopenic purpura; intravenous immunoglobulin.
Source: PubMed