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Type: Journal article
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
Author: Empson, M.
Tang, M.
Pearce, L.
Rozen, L.
Gold, M.
Katelaris, C.
Langton, D.
Smart, J.
Smith, W.
Steele, R.
Ziegler, J.
Maher, D.
Citation: Journal of Clinical Immunology, 2012; 32(5):897-906
Publisher: Kluwer Academic/plenum Publ
Issue Date: 2012
ISSN: 0271-9142
Statement of
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
RMID: 0020126689
DOI: 10.1007/s10875-011-9641-4
Appears in Collections:Paediatrics publications

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