New data published on Ruconest's effect on blood clotting parameters during HAE attacks

Published : Tuesday, January 24, 2012
New data published on Ruconest's effect on blood clotting parameters during HAE attacks

Biotech company Pharming Group NV announced that recombinant human C1 inhibitor (rhC1INH; RUCONEST®) was not observed to have a prothrombotic effect when used to treat acute Hereditary Angioedema (HAE) attacks in a study published by Relan et al in the peer-reviewed journal Biodrugs.


These results can be found online and will be published in print on 1 February 2012 in Biodrugs issue 26:1.

Thrombotic events have been reported at the recommended dose of plasma-derived C1 inhibitor products following treatment of HAE. To investigate the effect of RUCONEST on blood clotting parameters, blood samples of 25 HAE patients experiencing an angioedema attack included in a randomized clinical tr ial were analyzed for levels of coagulation (clotting) and fibrinolytic (clot dissolution) parameters before and after infusion of saline placebo, RUCONEST 50 U/kg, or RUCONEST 100 U/kg.

The findings in this study suggest that HAE patients feature changes in coagulation and fibrinolytic parameters during an HAE attack. Administration of RUCONEST dose-dependently restored the balance in the intrinsic coagulation pathway and resulted in a reduction of thrombin generation. No harmful effect was observed either on other coagulation or fibrinolysis activation parameters.

Pharming’s Chief Medical Officer, Dr. Rienk Pijpstra, commented: “These findings suggest that, contrary to being thrombogenic, in this study RUCONEST did not have any negative effect on the clotting parameters.”