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Clinical Data Suggest Decreased Bleeding Risk in People With Severe,Hemophilia A While Maintaining Factor VIII Levels Above One Percent

p was treated for 75 exposure days on a fixed prophylactic regimen of 25-40 IU/kg 3-4 times a week irrespective of bleeding. Prophylaxis could be modified by the physician (or investigator) for the one to six year old group.

By analyzing individual pharmacokinetic data and doses infused, Collins and coauthors were able to estimate the median number of hours per week spent below the 1 IU/dL trough level for each population, 19.7 hours and 16.5 hours for the one to six year old and 10 to 65 years old groups respectively. Subsequent comparison with bleed frequency for each group found that in the one to six years of age group the time below 1 IU/dL while on prophylaxis was associated with increased incidence of traumatic and spontaneous total bleeds (p<0.0001). Similarly in subjects that remained on a fixed prophylactic regimen in the 10 to 65 years age group, the duration of time below 1IU/dL was associated with increased total and joint bleeds (p<0.02).

"ADAPT continues to generate important information relating treatment with outcomes for people with hemophilia A," said Bruce Ewenstein, M.D., Ph.D., global medical director for hemophilia therapies at Baxter. "These data from the ADVATE clinical program have provided valuable insight into the potential role of maintaining trough levels above 1 IU/dL to reduce the risk of breakthrough bleeding."

Additionally, a poster presentation of data from ADAPT, results showed that bleeding patterns in people with severe hemophilia using standard prophylaxis therapy vary according to age groups. For both adolescents and adults, joint bleeds were more likely to occur in the summer, possibly due to increased physical activity. Furthermore, in patients on a Monday-Wednesday- Friday dosing schedule, a greater number of joint bleeds occurred on Sundays, reaching statistical significance in adults (18 to 65 years of age). The results support the concept of individual tailoring of prophylactic regimens according to
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