Observations regarding the immunogenicity of BDD-rFVIII derived from a mechanistic personalized medicine perspective.
ABSTRACT Aledort et al. recently reported the results of a meta-analysis of prospective clinical trials of the two classes of recombinant Factor VIII (rFVIII) products, B-domain-deleted (BDD) and full-length (FL) . The authors claimed that exposure to BDD-rFVIII was associated with an increased risk of de novo inhibitors. A detailed critique of the meta-analysis conducted in this report was provided by Iorio et al.  and the conclusions of Aledort and coworkers remain highly controversial. © 2012 International Society on Thrombosis and Haemostasis.