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®).

Hdl Handle:
http://hdl.handle.net/10147/139950
Title:
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 L; Singleton, 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.
Citation:
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 Haemophilia
Journal:
Haemophilia : the official journal of the World Federation of Hemophilia
Issue Date:
May-2011
URI:
http://hdl.handle.net/10147/139950
DOI:
10.1111/j.1365-2516.2010.02430.x
PubMed ID:
21382134
Additional Links:
http://www.ncbi.nlm.nih.gov/pubmed/21382134
Abstract:
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:
Article
Language:
en
MeSH:
Adolescent; Adult; Autoantibodies; Blood Coagulation Factor Inhibitors; Child; Child, Preschool; Factor VIII; Hemophilia A; Humans; Recombinant Proteins; Retrospective Studies; Serum Albumin; Young Adult
ISSN:
1365-2516

Full metadata record

DC FieldValue Language
dc.contributor.authorBacon, C Len
dc.contributor.authorSingleton, Een
dc.contributor.authorBrady, Ben
dc.contributor.authorWhite, Ben
dc.contributor.authorNolan, Ben
dc.contributor.authorGilmore, R Men
dc.contributor.authorRyan, Cen
dc.contributor.authorKeohane, Cen
dc.contributor.authorJenkins, P Vinceen
dc.contributor.authorO'Donnell, J Sen
dc.date.accessioned2011-08-17T08:49:56Z-
dc.date.available2011-08-17T08:49:56Z-
dc.date.issued2011-05-
dc.identifier.citationLow 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 Haemophiliaen
dc.identifier.issn1365-2516-
dc.identifier.pmid21382134-
dc.identifier.doi10.1111/j.1365-2516.2010.02430.x-
dc.identifier.urihttp://hdl.handle.net/10147/139950-
dc.description.abstractPrevious 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.-
dc.language.isoenen
dc.relation.urlhttp://www.ncbi.nlm.nih.gov/pubmed/21382134en
dc.subject.meshAdolescent-
dc.subject.meshAdult-
dc.subject.meshAutoantibodies-
dc.subject.meshBlood Coagulation Factor Inhibitors-
dc.subject.meshChild-
dc.subject.meshChild, Preschool-
dc.subject.meshFactor VIII-
dc.subject.meshHemophilia A-
dc.subject.meshHumans-
dc.subject.meshRecombinant Proteins-
dc.subject.meshRetrospective Studies-
dc.subject.meshSerum Albumin-
dc.subject.meshYoung Adult-
dc.titleLow 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®).en
dc.typeArticleen
dc.contributor.departmentNational Centre for Hereditary Coagulation Disorders, St. James's Hospital, Dublin, Ireland.en
dc.identifier.journalHaemophilia : the official journal of the World Federation of Hemophiliaen
dc.description.provinceLeinster-

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