Baxter International Inc. announced the results of a multi-national study to assess the safety, efficacy and inhibitor rates associated with ADVATE®, its recombinant factor VIII product. The results were reported at the World Federation of Hemophilia 2010 Congress in Buenos Aires, Argentina in July. The study was also published online June 22, 2010, in the journal Haemophilia.
The study included 521 previously treated patients (PTPs) with severe to moderately severe hemophilia A. The participants, including patients from both the European Union (E.U.) and the U.S., were treated with ADVATE® on either a prophylactic (preventive) or an on-demand basis.
The post-authorization safety surveillance (PASS) data yielded from the study showed that the safety and efficacy profile of ADVATE® remains comparable to what was demonstrated in previous, prospective clinical trials of the product. Inhibitor rates also remained comparable. In PTPs with severe to moderately severe hemophilia A the inhibitor rate was 0.29%, similar to the 0.51% percent inhibitor rate found in an earlier, smaller clinical study using ADVATE®.
“Importantly, the E.U./U.S. PASS data confirm patients on ADVATE®, particularly those with previous exposure to factor VIII products, had a low risk of developing an inhibitor, the management of which remains the greatest challenge for physicians and patients with hemophilia A today,” said lead investigator Johannes Oldenburg, MD, PhD, head, Institute of Experimental Haematology and Transfusion Medicine, University Clinic Bonn, Germany. “The data from the large registry involving a broad population of patients with hemophilia A are important because they corroborate the safety, immunogenicity profile and efficacy of ADVATE in real-world practice.”
Source: Baxter press release dated July 13, 2010