Eloctate, Alprolix control bleeds in hemophilia patients’ major surgeries
Data: Extended half-life therapies helped maintain stable clotting factor levels
Treatment with the extended half-life (EHL) therapies Eloctate (efmoroctocog alfa) and Alprolix (eftrenonacog alfa) was found to safely and effectively control bleeding during major orthopedic surgeries in people with hemophilia A or B, according to real-world data from two Italian centers.
The therapies helped patients maintain stable clotting factor levels throughout the surgical period, with a low risk of bleeding and no treatment-related side effects.
The study, “Orthopaedic Surgery Outcomes in Patients With Haemophilia A or B Treated With Extended Half-Life Recombinant Factor VIII and IX Fc Fusion Proteins: A Multicentre Prospective Study,” was published in Haemophilia.
Eloctate, Alprolix designed to stay in bloodstream longer
Hemophilia A and B are bleeding disorders caused by missing or faulty clotting proteins — factor VIII in hemophilia A and factor IX in hemophilia B. Without these proteins, even small injuries can cause prolonged bleeding, which can damage joints and lead to the need for orthopedic surgery.
The standard treatment involves replacing the missing clotting factor with lab-made versions. While many replacement therapies are approved, EHL therapies such as Eloctate and Alprolix are designed to stay longer in the bloodstream, allowing for less-frequent infusions.
However, evidence on their use around major surgeries, when patients need continuous bleeding control, remains limited.
To learn more, a group of researchers in Italy followed 19 adult men with hemophilia (14 with hemophilia A, five with hemophilia B) who underwent 20 major orthopedic surgeries between 2018 and 2023 at two reference centers in Milan and Florence. One patient had two procedures on different joints.
The most common procedures were ankle arthroplasty (45%) and knee arthroplasty (25%), both joint replacement surgeries that aim to reduce pain and improve mobility in joints damaged by repeated bleeding.
All participants received the appropriate EHL therapy — Eloctate for hemophilia A or Alprolix for hemophilia B — following international treatment guidelines. This included a loading dose before surgery and additional doses during and after surgery, as needed, to maintain factor levels between 80 and 100 international units per decilitre (IU/dL).
Bleeding control rated as ‘good’ in 95% of cases
Before surgery, patients with hemophilia A had a median factor VIII level of 12 IU/dL, which rose to 150 IU/dL after receiving Eloctate. Levels remained steady during recovery, ranging from 129 IU/dL immediately after surgery to 86 IU/dL one week later or at discharge.
The median factor VIII consumption during hospitalization for these patients was 300 IU/kg.
Patients with hemophilia B had a median preoperative factor IX level of 7 IU/dL, which increased to 82 IU/dL after the first dose of Alprolix. Their levels also stayed stable during hospitalization, with a median factor IX consumption of 388 IU/kg.
In total, patients with hemophila A received a median of 9.5 Eloctate infusions. Those with hemophilia B received a median of 11 Alprolix infusions.
Our study supports the role of [Eloctate and Alprolix] as effective and safe options for managing haemostasis in major orthopaedic surgery for persons with haemophilia.
Overall, bleeding control was rated as “good” in 95% of cases, meaning it was able to control or prevent bleeding, with no transfusions required.
Nine patients (45%) experienced post-surgery complications, mostly anemia — low levels of hemoglobin, the protein in red blood cells that transports oxygen — or minor surgical-site bleeding.
No blood clots or side effects related to Eloctate or Alprolix were reported. The median hospital stay was seven days, and no patients required repeat procedures or delayed discharge.
“Our study supports the role of [Eloctate and Alprolix] as effective and safe options for managing haemostasis in major orthopaedic surgery for persons with haemophilia,” the researchers concluded. “Further multicentre studies are warranted to confirm these results and refine perioperative management guidelines.”
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