Analyses of the FranceCoag cohort support immunogenicity differences among one plasma-derived and two recombinant factor VIII brands in boys with severe hemophilia A.

Analyses of the FranceCoag cohort support immunogenicity differences among one plasma-derived and two recombinant factor VIII brands in boys with severe hemophilia A. Haematologica. 2017 Oct 12;: Authors: Calvez T, Chambost H, d'Oiron R, Dalibard V, Demiguel V, Doncarli A, Gruel Y, Huguenin Y, Lutz P, Rothschild C, Vinciguerra C, Goudemand J, FranceCoag Collaborators Abstract Around one third of boys with severe hemophilia A develop inhibitors (neutralizing antibodies) against their therapeutic factor VIII product. This adverse effect may result in more life-threatening bleeding, disability, impaired quality of life, and costly care. We compared the inhibitor incidence in boys treated with the three factor VIII products most used in France: one plasma-derived (Factane) and two recombinant products (Advate and Kogenate Bayer). A previously untreated patient cohort was created in 1994 to investigate risk factors for inhibitor development. We selected boys with severe hemophilia A (factor VIII <1 IU/dL) first treated with one of the three factor VIII products studied. Details of product infusions, inhibitor assays and main fixed and time-varying inhibitor risk factors were recorded for the first 75 exposure days. Three outcomes (all inhibitors, high-titer inhibitors and subsequently treated inhibitors) were analyzed by uni- and multivariate Cox models. We studied 395 boys first treated between 2001 and 2016 (131, 137, and 127 with Fa...
Source: Haematologica - Category: Hematology Authors: Tags: Haematologica Source Type: research