Inhibitors are a significant problem in hemophilia. People with hemophilia who use factor based on recombinant products could have nearly twice as many inhibitors as those using plasma factor.
Patients with hemophilia had almost twice the risk of developing alloantibodies when treated with recombinant factor VIII instead of plasma-derived factor, a randomized trial showed.
Overall, inhibitor development occurred in 35.4% of 251 randomized patients. Patients who received recombinant factor VIII had a hazard ratio for inhibitor development of 1.87 compared with the group randomized to receive plasma-derived factor VIII. Analysis of the subgroup of patients with high-titer inhibitors showed a 70% greater risk of inhibitor development with recombinant product.
A multivariate analysis that accounted for a dozen demographic and clinical factors showed a consistent pattern of increased risk of inhibitor formation in patients treated with recombinant factor VIII, Flora Peyvandi, MD, PhD, of the University of Milan, reported here at the American Society of Hematology meeting.
“Patients treated with recombinant factor VIII have an 87% higher risk to develop inhibitors than those treated with platelet-derived factor VIII containing von Willebrand factor,” Peyvandi said in conclusion. “This difference remained even when second-generation full length recombinant factor VIII concentrate was excluded from the analyses.
“These findings are clinically important because the development of factor VIII alloantibodies is currently the major therapeutic complication in hemophilia A that causes a marked increase in morbidity, mortality, and treatment costs.”
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