Low risk of inhibitor formation in haemophilia A patients following en masse switch in treatment to a third generation full length plasma and albumin-free recombinant factor VIII product (ADVATE®).
Authors
Bacon, C LSingleton, E
Brady, B
White, B
Nolan, B
Gilmore, R M
Ryan, C
Keohane, C
Jenkins, P Vince
O'Donnell, J S
Affiliation
National Centre for Hereditary Coagulation Disorders, St. James's Hospital, Dublin, Ireland.Issue Date
2011-05MeSH
AdolescentAdult
Autoantibodies
Blood Coagulation Factor Inhibitors
Child
Child, Preschool
Factor VIII
Hemophilia A
Humans
Recombinant Proteins
Retrospective Studies
Serum Albumin
Young Adult
Metadata
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Low risk of inhibitor formation in haemophilia A patients following en masse switch in treatment to a third generation full length plasma and albumin-free recombinant factor VIII product (ADVATE®). 2011, 17 (3):407-11 HaemophiliaJournal
Haemophilia : the official journal of the World Federation of HemophiliaDOI
10.1111/j.1365-2516.2010.02430.xPubMed ID
21382134Additional Links
http://www.ncbi.nlm.nih.gov/pubmed/21382134Abstract
Previous studies have suggested that development of inhibitors in previously treated patients (PTPs) may be attributable to a switch in factor VIII (FVIII) therapeutic product. Consequently, it is widely recognized that inhibitor development must be assessed in PTPs following the introduction of any new FVIII product. Following a national tender process in 2006, all patients with haemophilia A in Ireland changed their FVIII treatment product en masse to a plasma and albumin-free recombinant full-length FVIII product (ADVATE(®)). In this study, we retrospectively reviewed the case records of Irish PTPs to evaluate risk of inhibitor formation following this treatment switch. One hundred and thirteen patients participated in the study. Most patients (89%) had severe haemophilia. Only one of 96 patients with no inhibitor history developed an inhibitor. Prior to the switch in his recombinant FVIII (rFVIII) treatment of choice, this child had only experienced three exposure days (EDs). Consequently, in total he had only received 6 EDs when his inhibitor was first diagnosed. In keeping with this lack of de novo inhibitor development, we observed no evidence of any recurrent inhibitor formation in any of 16 patients with previously documented inhibitors. Similarly, following a previous en masse switch, we have previously reported that changing from a Chinese hamster ovary cell-produced to a baby hamster kidney cell-produced rFVIII was also associated with a low risk of inhibitor formation in PTPs. Our cumulative findings from these two studies clearly emphasizes that the risk of inhibitor development for PTPs following changes in commercial rFVIII product is low, at least in the Irish population.Item Type
ArticleLanguage
enISSN
1365-2516ae974a485f413a2113503eed53cd6c53
10.1111/j.1365-2516.2010.02430.x
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