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Eloctate effective in prevention of target joint bleeding

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Patients with severe hemophilia A who took Eloctate prophylactically experienced reduced annualized bleeding rates overall and in target joints, according to an abstract presented at the ASH Annual Meeting and Exposition.

Data indicate that Eloctate (antihemophilic factor (recombinant) Fc fusion protein, Biogen Idec) is effective in the long-term prevention of target joint bleeding in patients with severe hemophilia A.

Bryce A. Kerlin, MD, principal investigator at the Center for Clinical and Translational Research at Nationwide Children's Hospital, Columbus, Ohio, and colleagues, as part of the ongoing extension study, ASPIRE, investigated long-term efficacy of recombinant FVIII Fc fusion protein (rFVIIIFc) in adults, adolescents and children who had target joints when they entered the parent studies A-LONG and Kids A-LONG.

"The phase 3 A-LONG and Kids A-LONG studies demonstrated the safety and efficacy of rFVIIIFc for control and prevention of bleeding episodes in subjects with severe hemophilia A," the researchers wrote.

Kerlin and colleagues analyzed a group of 111 adults and adolescents and 13 pediatric participants who were assigned to one of four treatment groups: individualized prophylaxis, weekly prophylaxis, modified prophylaxis or episodic treatment. Participants younger than 12 years old were only able to participate in the individualized or modified prophylaxis groups.

Results showed that just less than half of the adult and adolescent participants in the individualized prophylaxis group, the weekly prophylaxis group and the modified prophylaxis group had no target joint bleeding episodes during A-LONG/ASPIRE (47.6%, 42.3% and 41.7%, respectively). Additionally, 53.8% of children in the IP group had no target joint bleeding episodes during Kids A-LONG/ASPIRE.

Kerlin and colleagues reported that median overall annualized bleeding rates were also lower than prestudy bleeding rates.

"For subjects with target joints at baseline, efficacy data from the phase 3 and extension trials suggest that long-term use of extended half-life rFVIIIFc prophylaxis is effective for prevention of target joint bleeding," Kerlin and colleagues concluded.

“As the first prolonged half-life therapies, Eloctate and Alprolix have shown low rates in both joint bleeding and overall annualized bleeding episodes,” Kate Dawson, MD, vice president of U.S. medical at Biogen, said in a press release. “Their ability to reduce bleed rates, which may translate into the potential for reducing some joint disease, continues to reaffirm their clinical value for people living with hemophilia A and B.” – by Chelsea Frajerman Pardes

Reference:

Kerlin BA, et al. Abstract 3520. Presented at: ASH Annual Meeting and Exposition; Dec. 5-8, 2015; Orlando, Fla.

Disclosures: Kerlin reports board of directors or advisory committee membership for Bayer Healthcare US and Novo Nordisk and research funding from CSL Behring. Please see the abstract for a full list of all other authors' relevant financial disclosures.