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|Title:||Efficacy, safety and pharmacokinetics of a novel subcutaneous immunoglobulin, Evogam®, in primary immunodeficiency|
|Other Titles:||Efficacy, safety and pharmacokinetics of a novel subcutaneous immunoglobulin, Evogam (R), in primary immunodeficiency|
|Citation:||Journal of Clinical Immunology, 2012; 32(5):897-906|
|Publisher:||Kluwer Academic/plenum Publ|
|Marianne B. Empson, Mimi L. K. Tang, Lisa K. C. Pearce, Leon Rozen, Michael S. Gold, Constance H. Katelaris, David Langton, Joanne Smart, William B. Smith, Richard H. Steele, John B. Ziegler, Darryl Maher|
|Abstract:||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.|
|Keywords:||Immunoglobulin therapy; primary immunodeficiency; subcutaneous immunoglobulin; intravenous immunoglobulin; quality of life|
|Rights:||© Springer Science+Business Media, LLC 2012|
|Appears in Collections:||Paediatrics publications|
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