Article ; Online: A prospective surveillance study of inhibitor development in haemophilia A patients following a population switch to a third-generation B-domain-deleted recombinant factor VIII.
Haemophilia : the official journal of the World Federation of Hemophilia
2018 Volume 24, Issue 2, Page(s) 236–244
Abstract: Introduction: Following a provincial tender, most subjects with haemophilia A in Quebec switched their treatment to a third-generation recombinant B-domain-deleted factor VIII (FVIII).: Aim: Our objective was to evaluate the incidence of inhibitor ... ...
| Abstract | Introduction: Following a provincial tender, most subjects with haemophilia A in Quebec switched their treatment to a third-generation recombinant B-domain-deleted factor VIII (FVIII). Aim: Our objective was to evaluate the incidence of inhibitor development and FVIII recovery in patients following the switch of factor replacement therapy. Methods: One hundred and thirty-five subjects were enrolled and tested for FVIII activity and inhibitors every 6 months during 1 year. Subjects with mild haemophilia A or current inhibitors were excluded. Data on demographics, bleeds and FVIII usage were collected. Results: A total of 125 switchers and 10 non-switchers were enrolled. Most subjects had severe haemophilia A (95.6%) and were on prophylaxis (89.6%). Mean FVIII recovery was similar at 0, 6 and 12 months postswitch. Two switchers developed de novo inhibitors in the 6 months postswitch, one of which was transient. No recurrent inhibitor was observed. A small but significant increase in FVIII usage was observed for adult switchers and the whole cohort of switchers and non-switchers. There was an increase in the annualized bleeding rate (ABR) for non-joint bleeds for the whole cohort of switchers. However, no significant differences were observed in ABR for joint bleeds. Conclusion: Our surveillance study shows comparable inhibitor development to similar published studies. A significant increase in FVIII utilization was noted for the whole cohort, switchers and non-switchers. Lastly, no clinically significant changes were observed in ABR for joint bleeds, but a difference for non-joint bleed ABRs was observed in switchers. |
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| MeSH term(s) | Adult ; Factor VIII/therapeutic use ; Female ; Hemophilia A/drug therapy ; Humans ; Male ; Prospective Studies | ||||||||||
| Chemical Substances | Factor VIII (9001-27-8) | ||||||||||
| Language | English | ||||||||||
| Publishing date | 2018-02-01 | ||||||||||
| Publishing country | England | ||||||||||
| Document type | Journal Article | ||||||||||
| ZDB-ID | 1229713-6 | ||||||||||
| ISSN | 1365-2516 ; 1351-8216 ; 1355-0691 | ||||||||||
| ISSN (online) | 1365-2516 | ||||||||||
| ISSN | 1351-8216 ; 1355-0691 | ||||||||||
| DOI | 10.1111/hae.13410 | ||||||||||
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| Database | MEDical Literature Analysis and Retrieval System OnLINE |
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