Safety and efficacy of intravenous immunoglobulin (Flebogamma® 10% DIF) in patients with immune thrombocytopenic purpura.

Journal: Immunotherapy
Published:
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.

Authors
Shashikant Apte, Jordi Navarro Puerto, Sharat Damodar, Vijay Ramanan, Joseph John, Giraldo Kato, Cecil Ross, Chirag Shah, Marcela Torres, Chieh-lin Fu, Karen Rucker, Paul Pinciaro, Gladis Barrera, Maria Aragonés, Jaume Ayguasanosa