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 4-69. years) were treated for 148. weeks in the EU (N. = 40; 5405 infusions) and 87. weeks in the US (N. = 21; 1735 infusions). Weekly doses were 116.0. mg/kg (EU) and 193.2. mg/kg (US); IgG levels were 7.97. g/L (EU) and 11.98. g/L (US). Annualized rates of serious bacterial infections were 0.05. infections/subject/year (EU) and 0.06. infections/subject/year (US). Rates of any infection were 3.33. infections/subject/year (EU) and 2.38. 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 3. years. © 2013.
S., J., M., B., R.P., N., M., R., M., B., & J.-P., L. (2014). Long-term efficacy, safety, and tolerability of Hizentra for treatment of primary immunodeficiency disease. Clinical Immunology. S. Jolles, Department of Immunology, University Hospital of Wales, Heath Park, Cardiff CF14 4XW, United Kingdom. E-mail: firstname.lastname@example.org: Academic Press Inc. (1250 Sixth Avenue, San Diego, California CA 92101, United States). Retrieved from http://ovidsp.ovid.com/ovidweb.cgi?T=JS&PAGE=reference&D=emed12&NEWS=N&AN=2014025800