Bayer HealthCare has announced that Kogenate ( Octocog alfa ) is effective and well tolerated at reducing bleeding frequency in adults with severe hemophilia A when administered as a secondary prophylactic regimen versus on-demand treatment.

The SPINART study, which is ongoing, was designed to evaluate the effect of secondary prophylaxis with Kogenate on bleeding frequency and joint damage compared to episodic treatment in adults with severe hemophilia A.

A total of 84 subjects were randomized to either receive prophylaxis ( 25 IU/kg three times per week ) or on-demand treatment, with a total follow up period of 3 years.

After a median follow-up period of 1.7 years, results show significantly fewer total bleeding events occurred per year with prophylaxis vs on-demand ( median, 0.0 vs 27.9 respectively, p < 0.0001. No bleeds seen in 52% of prophylaxis patients ).

The results also showed significantly fewer joint bleeds on prophylaxis as compared to on-demand ( median, 0.0 vs 21.2. No bleeds seen in 62% of prophylaxis patients ).

The majority of bleeds in prophylaxis patients were mild ( 44% ) or moderate ( 36% ), while most bleeds in on-demand patients were moderate ( 58% ) or severe ( 19% ). Observed adverse events were consistent with the product insert and no inhibitor formation was observed.

Source: 50th annual World Federation of Hemophilia ( WFH ) World Congress, 2012

XagenaMedicine2012