Baxter International Inc. (NYSE:BAX) today presented clinical data on Baxter’s leading recombinant factor VIII treatment, including interim data from the first year of observation from the AHEAD (ADVATE HaEmophilia A Database) study, a four-year outcomes registry of hemophilia A patients treated with ADVATE [Antihemophilic Factor (Recombinant) Plasma/Albumin-Free Method]. These data were presented during the European Association for Haemophilia and Allied Disorders (EAHAD) meeting in Brussels, Belgium.
These real-world data, which support the clinical experience of prophylaxis treatment with ADVATE, found that the majority of patients (55.3%) on prophylaxis had fewer than two bleeding episodes per year, with a median annual bleed rate (ABR) of 1.1. Of these patients, 51 percent experienced no bleeds during one year of treatment.
''ADVATE delivers proven clinical performance, with similar data in routine clinical settings as those reported in controlled clinical trials. The growing body of prophylaxis data provides physicians and patients even more support for this prophylactic treatment and add to the robust body of evidence available on its safety and efficacy,'' said Ludwig Hantson, Ph.D., president of Baxter’s BioScience business. ''These data strongly support the concept of treating prophylactically to reduce the risk of bleeding episodes, a measurable target that we continue to pursue as part of our vision of a bleed free world.''
About the AHEAD StudyA total of 562 hemophilia A patients have been enrolled to date, 77 percent of whose hemophilia is severe. Of the 115 patients from the European arm who have been followed for at least one year and have provided data on their annual bleed rate, 85 were treated with ADVATE prophylactically and 30 were treated on-demand. Of the patients on prophylactic treatment, more than half (55.3%) reached an ABR of 0-2; and 51 percent of this group experienced no bleeds during one year of treatment. The median ABR was 1.1 for prophylaxis and 11.8 for on-demand patients, consistent with previously published studies. The overall effectiveness was rated as ''excellent or good'' in 97.6 percent for prophylaxis treatment and 92.9 percent for on-demand treatment.