Pfizer recently published the results to its Phase 3 study of BeneFIX Coagulation Factor IX (recombinant) 100 IU/kg prophylaxis compared to on-demand treatment for patients with moderately severe or severe hemophilia B.
The Phase 3 results were published in the World Federation of Hemophilia’s official journal, Haemophilia.
The results of the study showed that BeneFIX, which was designed as a once-a-week prophylactic regimen, considerably reduced bleeding. The reduction of bleeding is a primary goal when combating hemophilia. Data from the Phase 3 study showed that the median annualized bleeding rate (ABR) values were 2.0. This included numbers in the range of 0.0 to 13.8 during the period when BeneFIX was used. The on-demand treatment period results had a median ABR of 33.6 in a range of 6.1 to 69.0. During the 52-week study, 36 percent of patients did not suffer any type of bleeding events and 48 percent of patients did not suffer any spontaneous bleeding events.
Adverse events of the prophylactic regimen reported during the study mirrored those of the on-demand treatment. Occurring most often, in 10 percent of the patients, were arthralgia, back pain, headache, joint swelling, nasopharyngitis, pharyngitis, pyrexia, toothache and upper respiratory tract infection.