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No differences observed between Factor VIII products in hemophilia
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Plasma-derived and recombinant Factor VIII products yielded similar antibody development in hemophilia A, according to study results.
Researchers conducted the investigation to evaluate which type of Factor VIII product was linked to development of clinically relevant inhibitory antibodies in a cohort of 574 consecutive patients with severe hemophilia A (Factor VIII activity, <0.01 IU/mL).
Eligible participants were born between 2000 and 2010. The researchers analyzed data for all clotting-factor administration for up to 75 exposure days.
Inhibitor development — defined as “at least two positive inhibitor tests with decreased in vivo recovery of Factor VIII levels — served as the primary endpoint.
The incidence of inhibitory antibody development was 32.4%, with 177 of 574 children developing them.
High titer inhibitory antibodies were defined as a peak titer of at least 5 Bethesda units per milliliter. These developed in 116 children (cumulative incidence, 22.4%).
Plasma-derived products and recombinant products carried a similar risk of inhibitor development (adjusted HR as compared with recombinant products, 0.96; 95% CI, 0.62-1.49).
The investigators observed an increased risk of inhibitor development for second-generation full-length products as compared with third-generation full-length recombinant products (derived from the full-length complementary DNA sequence of human Factor VIII; adjusted HR=1.6; 95% CI, 1.08-2.37).
No increased risk was associated with the content of von Willebrand factor in the products, nor was there a risk in switching among products.
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