Inhibitor Incidence Is Similar for Recombinant, Plasma-Derived FVIII Treatment Products
The study confirmed that recombinant and plasma-derived FVIII treatment products are associated with similar risk.
Both recombinant factor VIII (rcFVIII) and plasma-derived factor VIII (pdFVIII) products demonstrate similar inhibitor incidence when used to treat patients with severe hemophilia A (HA), according to a study published in Haemophilia.
This study provided an update to a similar research conducted by the RODIN study group in nearly 600 previously untreated patients with severe HA based on data collected through June 2011. The updated data included more patients and longer follow-up periods.
Researchers assessed 988 previously untreated patients registered in the PedNet registry who had received at least 1 exposure day; 805 patients used an rcFVIII product and 103 patients used a pdFVIII product. Inhibitor incidence was found to be 29% for class rcFVIII and 28% for class pdFVIII. Additionally, 21% of patients who used rcFVIII and 20% of patients who used pdFVIII exhibited high-titer inhibitors, defined as an inhibitor titer greater than 5 BU/ml.
This study reinforced the findings of the RODIN study, which reported inhibitor incidences ranging from 28.2% to 33.1% for various rcFVIII and pdFVIII products.
Further analysis to account for individual genetic and treatment-related risk factors is currently under way.
- Gouw SC, van der Bom JG, Ljung R, et al. Factor VIII Products and Inhibitor Development in Severe Hemophilia A [published online September 24, 2018]. N Engl J Med. doi: 10.1056/NEJMoa1208024
- Van denBerg HM, Carcao M, Kenet G, et al. Inhibitor incidence in 1083 PUPs with severe haemophilia A treated with class recombinant or with class plasma-derived products is similar; recent data from the PedNet study group [Abstract M-LBMED01-002 (884)]. Haemophilia. 2018;24(suppl 5):209.