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Extension Study Supports Long-Term Safety and Efficacy of Eloctate
Newly published clinical data demonstrate that people on extended-interval prophylaxis regimens with antihemophilic factor (recombinant), Fc fusion protein (Eloctate, Biogen/Sobi) experienced low bleeding rates.
The interim results of this phase 3, open-label extension study called ASPIRE were published in the online edition of Haemophilia, the journal of the World Federation of Hemophilia, the European Association for Haemophilia and Allied Disorders, and the Hemostasis & Thrombosis Research Society.
Study participants completing the phase 3 A-LONG and Kids A-LONG studies were eligible to participate in ASPIRE. The results to date show the majority of participants in ASPIRE maintained or extended their dosing intervals between treatments compared with the A-LONG and Kids A-LONG studies.
As of the interim analysis, the median time in the ASPIRE study was 80.9 weeks for adults and adolescents completing the A-LONG study, and 23.9 weeks for children completing the Kids A-LONG study. Inhibitor development is the primary endpoint of ASPIRE and no inhibitors were reported in any treatment groups. Through the interim ASPIRE analysis, adults and adolescents experienced annualized bleeding rates (ABRs) of 0.66, 2.03, and 1.97 in the individualized, weekly, and modified prophylaxis arms, respectively. Children on individualized prophylaxis also experienced low bleeding rates, with an overall median ABR of 0.0 in children less than 6 years of age, and 1.54 for children ages 6 to 12. These results were consistent with data from the phase 3 A-LONG and Kids A-LONG studies.
In addition to efficacy and safety endpoints, the publication also reports changes in prophylactic infusion frequency from the end of the A-LONG study through the interim analysis. Of the adults and adolescents who had previously been treated prophylactically and who remained in the study through the interim analysis (n = 128), 72% maintained their prophylactic dosing interval; 22% lengthened and 6% shortened the time between infusions. Extension study participants could change treatment group at any time.
In ASPIRE, most participants received prophylactic treatment and were able to maintain protection against bleeding episodes with Eloctate consumption that was consistent with that observed in A-LONG and Kids A-LONG.
The publication reported cumulative duration of treatment from the beginning of the A-LONG and Kids A-LONG studies through the ASPIRE interim data analysis. The median cumulative duration of treatment was 117.7 weeks for adults and adolescents, and 51.5 weeks for children less than 12 years old.
Across age groups, safety results were consistent with the general hemophilia A population. There were no reports of serious allergic reactions or vascular clots. The most common adverse events (incidence of greater than or equal 5%) included nasopharyngitis, arthralgia, and upper respiratory infection.
ASPIRE enrolled 211 males, including 150 (98%) of those who completed A-LONG and 61 (91%) of those who completed Kids A-LONG.
Eloctate is indicated in the United States for the control and prevention of bleeding episodes, perioperative management, and routine prophylaxis in adults and children with hemophilia A. It was introduced in the U.S. in July 2014.
Source: Biogen/Sobi; August 10, 2015.