Baxter International Inc. (NYSE:BAX) today presented two comprehensive analyses supporting the proven clinical and real-world results of ADVATE [Antihemophilic Factor (Recombinant), Plasma/Albumin-Free Method] during the 24 th Annual Congress of the International Society on Thrombosis and Haemostasis (ISTH) in Amsterdam, The Netherlands. The presentations include two complementary studies of the ADVATE profile, including an analysis of post-marketing data from approximately 1,200 hemophilia A patients across 15 countries as well as safety findings from a 10-year database of 12 clinical trials.
A meta-analysis of post-authorization safety studies (PASS) (abstract# PO148) presented at ISTH supports the overall product safety and effectiveness profile, as well as low rate of inhibitor development with ADVATE, with only one de-novo inhibitor in severe previously-treated patients (n=669) with more than 150 prior exposure days. 1 The analysis assessed the effectiveness of ADVATE treatment in non-controlled, real-world clinical practice, and found that the median annual bleed rate (ABR) for patients on continuous prophylaxis (twice a week or more, n=560) was 1.67, which supports the ABR reported in controlled clinical studies. 2 The effectiveness result in the study captured ADVATE efficacy in routine clinical practice (as opposed to efficacy, which measures in a controlled, interventional trial setting). The meta-analysis included patients from the United States, Australia, Japan, and 12 countries in Europe, who were followed for more than one year with exposure to ADVATE ranging between 85 and 103 mean exposure days across five studies. 1
''This meta-analysis of the post-market surveillance database, the largest available in hemophilia today, demonstrates a global patient experience with ADVATE that is consistent with the results reported in our highly controlled clinical programs,'' said Bruce Ewenstein, M.D., Ph.D., vice president of clinical affairs for Baxter. ''Given the broad range of patients and hemophilia clinical practice around the world, it is significant that these data continue to support the low inhibitor rate among patients using ADVATE as well as the effectiveness of bleed prevention when on an ADVATE prophylaxis regimen.''