کد مقاله | کد نشریه | سال انتشار | مقاله انگلیسی | نسخه تمام متن |
---|---|---|---|---|
6087579 | 1589430 | 2014 | 9 صفحه PDF | دانلود رایگان |
- Annualized serious bacterial infection rates were â¤Â 0.06 per subject per year.
- Annualized rates of any infection were low among subjects across a wide age range.
- Lower rates of bronchopulmonary infections were observed with higher doses of SCIG.
- No treatment-related discontinuations occurred, supporting long-term tolerability.
- Weekly infusions were well tolerated throughout a treatment period of up to 3Â years.
Hizentra® (20% subcutaneous immunoglobulin [SCIG]) was administered to subjects with primary immunodeficiency disease in two extension studies in the EU and US to assess long-term efficacy and tolerability. Subjects (aged 4-69Â years) were treated for 148Â weeks in the EU (NÂ =Â 40; 5405 infusions) and 87Â weeks in the US (NÂ =Â 21; 1735 infusions). Weekly doses were 116.0Â mg/kg (EU) and 193.2Â mg/kg (US); IgG levels were 7.97Â g/L (EU) and 11.98Â g/L (US). Annualized rates of serious bacterial infections were 0.05Â infections/subject/year (EU) and 0.06Â infections/subject/year (US). Rates of any infection were 3.33Â infections/subject/year (EU) and 2.38Â infections/subject/year (US). The rate of bronchopulmonary infections was higher in the EU study. No treatment-related serious AEs occurred; no subject discontinued because of treatment-related AEs. Self-administered Hizentra afforded sustained effective protection from infections and favorable tolerability during an extended treatment period of up to 3Â years.
Journal: Clinical Immunology - Volume 150, Issue 2, February 2014, Pages 161-169