Please use this identifier to cite or link to this item: http://hdl.handle.net/2440/77254
Citations
Scopus Web of Science® Altmetric
?
?
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
1573-2592
Statement of
Responsibility: 
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

Files in This Item:
There are no files associated with this item.


Items in DSpace are protected by copyright, with all rights reserved, unless otherwise indicated.