Date: 2012-07-12
Type of information: Presentation of results at a congress
phase: 3
Announcement: presentation of results at the 50th annual World Federation of Hemophilia (WFH) World Congress, July 8-12, in Paris, France
Company: Bayer Healthcare (Germany)
Product: Kogenate® Bayer (octocog alfa)
Action mechanism:
Disease: hemophilia A
Therapeutic area: Hematological diseases - Genetic diseases
Country:
Trial
details: SPINART is an ongoing, phase III study evaluating the effect of secondary prophylaxis with rFVIII on bleeding frequency (number of bleeds per year) and on joint damage compared to episodic treatment in adults and adolescents.
Latest
news: Bayer HealthCare has announced that Kogenate® Bayer (octocog alfa) was 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. These data were presented as a late-breaker at the 50th annual World Federation of Hemophilia (WFH) World Congress, July 8-12, in Paris, France.
The SPINART study, which is ongoing, was designed to evaluate the effect of secondary prophylaxis with Kogenate Bayer on bleeding frequency and joint damage compared to episodic treatment in adults with severe hemophilia A.
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.
