1. Safety and efficacy of intravenous immunoglobulin (Flebogamma® 10% DIF) in patients with immune thrombocytopenic purpura
- Author
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Chirag Shah, Paul Pinciaro, Maria Esperança Aragonés, Karen Rucker, Gladis Barrera, Jaume Ayguasanosa, Sharat Damodar, Vijay Ramanan, Chieh-Lin 'Kathy' Fu, Shashikant Apte, Giraldo Kato, Marcela Torres, Joseph M John, Jordi Navarro-Puerto, and Cecil Ross
- Subjects
0301 basic medicine ,medicine.medical_specialty ,Immunology ,Gastroenterology ,03 medical and health sciences ,0302 clinical medicine ,Immune system ,hemic and lymphatic diseases ,Internal medicine ,medicine ,Immunology and Allergy ,In patient ,Platelet ,Adverse effect ,End point ,biology ,business.industry ,medicine.disease ,Thrombocytopenic purpura ,Flebogamma ,030104 developmental biology ,Oncology ,030220 oncology & carcinogenesis ,biology.protein ,Antibody ,business - 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.
- Published
- 2019
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