Study: Eloctate, Alprolix Effective at Preventing Surgical Bleeds
The extended half-life replacement therapies Eloctate and Alprolix can be used to effectively manage bleeding during surgery in people with hemophilia, according to a new study based on Phase 3 clinical trial data.
These findings highlight the “efficacy and safety of these products in a broad age range of patients undergoing a variety of major and minor procedures typical for a population with severe hemophilia,” the researchers wrote.
The study, “Managing surgery in hemophilia with recombinant factor VIII Fc and factor IX Fc: Data on safety and effectiveness from phase 3 pivotal studies,” was published in Research and Practice in Thrombosis and Haemostasis. The work was funded by Sobi and Sanofi, which collaboratively market both therapies.
Due to hemophilia patients’ high risk of bleeding during and after surgery, replacement therapy is used in the perioperative period (immediately before surgery through recovery).
Replacement therapy delivers to patients the missing clotting factor for that specific type of hemophilia: factor FVIII (FVIII) for type A and factor IX (FIX) for type B.
Extended half-life (EHL) replacement therapies such as Eloctate (recombinant FVIII fusion protein) and Alprolix (recombinant FIX fusion protein) take longer to be broken down by the body, meaning they work for longer periods of time after being infused into the bloodstream.
Both therapies are approved for the prevention and resolution of bleeds in people with hemophilia across all age groups.
Their approvals were based on data from Phase 3 clinical trials and extension studies showing they could lower bleeding rates and improve life quality in children, adolescents, and adults with hemophilia.
Eloctate was evaluated in the A-LONG (NCT01181128) and Kids A-LONG (NCT01458106) Phase 3 trials and the ASPIRE extension study (NCT01454739).
Alprolix was tested in the B-LONG (NCT01027364) and Kids B-LONG (NCT01440946) Phase 3 trials and the B-YOND extension study (NCT01425723).
Now, an international team of scientists analyzed data from these clinical trials specifically focusing on use of the therapies during surgery.
In Eloctate trials, the researchers identified 31 hemophilia A patients who underwent 45 major surgeries and 70 patients who underwent 90 minor surgeries. In Alprolix trials, 22 hemophilia B patients underwent 35 major surgeries and 37 participants underwent 62 minor surgeries.
The specific surgeries included a range of procedures. In both hemophilia types, the most common major surgery was joint replacement/revision (22 in hemophilia A patients and 10 in hemophilia B patients), while the most common minor surgery was tooth extraction (31 in hemophilia A patients and 24 in hemophilia B patients).
“To the best of our knowledge, this is the largest report of surgical procedures with EHL products to date,” the researchers wrote.
Results showed that a single dose of the corresponding EHL was administrated on the day of surgery in 86% of major surgeries in hemophilia A patients and 83% of those in hemophilia B patients. Also, 83% of minor surgeries in hemophilia A patients and 74% of minor surgeries in hemophilia B patients required only one dose during surgery.
The maximum number of reported doses on the day of surgery was three for Eloctate and four for Alprolix.
In both hemophilia types, the median estimated blood loss during major surgery was about 100 mL — less than a third the volume of a typical soda can.
Bleeding control was rated “excellent” in 93% of major surgeries with Eloctate and 88% of major surgeries with Alprolix, meaning that the observed blood loss was comparable to a person without hemophilia.
In all remaining major surgeries, the hemostatic, or bleed-preventing, response was categorized as “good.”
Trends similar for minor surgeries
Generally similar trends were seen for minor surgeries, though bleeding control in two dental procedures on Alprolix was rated as only “fair.”
Safety data were generally favorable, with no major treatment-related safety events reported during the surgical period and no changes in planned treatment schedules following surgery. No patient developed antibodies against the delivered clotting factors or experienced blood clot-related events.
The researchers concluded that both EHL therapies “were efficacious for the management of perioperative hemostasis across a wide spectrum of major and minor surgeries.”
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