Efficacy, Safety and Pharmacokinetics of a Novel Subcutaneous Immunoglobulin, Evogam®, in Primary Immunodeficiency

• Published in: Journal of clinical immunology Vol. 32; no. 5; pp. 897 - 906
• Main Authors: Empson, Marianne B., Tang, Mimi L. K., Pearce, Lisa K. C., Rozen, Leon, Gold, Michael S., Katelaris, Constance H., Langton, David, Smart, Joanne, Smith, William B., Steele, Richard H., Ziegler, John B., Maher, Darryl
• Format: Journal Article
• Language: English
• Published: Boston Springer US 01.10.2012
• Subjects: Adolescent; Adult; Aged; Biomedical and Life Sciences; Biomedicine; Child; Female; Humans; Immunoglobulin G - administration & dosage; Immunoglobulin G - blood; Immunoglobulin G - pharmacology; Immunologic Deficiency Syndromes - blood; Immunologic Deficiency Syndromes - drug therapy; Immunologic Factors - administration & dosage; Immunologic Factors - blood; Immunologic Factors - pharmacology; Immunology; Infectious Diseases; Injections, Subcutaneous; Internal Medicine; Male; Medical Microbiology; Middle Aged; Quality of Life; Young Adult; primary immunodeficiency; quality of life; intravenous immunoglobulin; Immunoglobulin therapy; subcutaneous immunoglobulin
• ISSN: 0271-9142; 1573-2592
• DOI: 10.1007/s10875-011-9641-4

This phase III, open-label, multi-centre study investigated the efficacy, safety, pharmacokinetics and quality of life impact of Evogam ® , a new chromatographically fractionated 16% subcutaneous immunoglobulin, utilising a 1:1 dose transition ratio from previous immunoglobulin therapy. Thirty-five previously treated patients with primary immunodeficiency received weekly Evogam over 36 weeks. Primary endpoints were rate of serious bacterial infections (SBIs) and steady-state serum immunoglobulin G (IgG) trough concentrations. No SBIs were reported during the study. Evogam produced significantly higher mean trough IgG concentrations with 1:1 dose conversion compared to previous immunoglobulin treatment (8.94 versus 8.27 g/L, p  = 0.0063). Evogam was efficacious in the prevention of infections and maintenance of trough levels using a 1:1 dose conversion. It was well tolerated with no withdrawals due to adverse events and was preferred to IVIg by the majority of patients.