Turoctocog Alfa Pegol in Surgical Procedures – Experiences from Pathfinder 3 and 5 Studies
The Haemophilia journal published data in May 2020 from 2 studies that summarize experiences with turoctocog alfa pegol during surgical procedures in adults, adolescents, and children with hemophilia A.
Turoctocog Alfa Pegol
The substance, also known as N8-GP (Esperoct®), is a glycopegylated recombinant FVIII with an extended half-life of up to 1.6× compared to regular recombinant FVIII with a standard half-life. PEG modification typically allows for a lower frequency of administration while ensuring very good prevention of bleeding.
Study Population and Goals of the Pathfinder Studies
In the pathfinder 3 study, adults and adolescents over 12 years old with severe hemophilia A treated with N8-GP were monitored with the goal of achieving FVIII levels > 80% during major surgical procedures (such as orthopedic surgeries including joint replacements or arthroscopic interventions, cholecystectomy, circumcision, pseudotumor removal, etc.). The primary endpoint was hemostatic efficacy, and secondary endpoints included blood loss, hemostatic effect in the postoperative period, factor consumption, need for erythrocyte transfusion, safety, and financial cost.
The pathfinder 5 study focused on children aged 11 and younger who underwent minor surgical procedures (tooth extraction, implantation or removal of implantofix, etc.) with preparation by administration of N8-GP at a dose of 20–75 IU/kg.
Results
The pathfinder 3 study included 35 patients who underwent a total of 49 major surgical procedures. Hemostasis was sufficient in 95.5% of cases, and the response was moderately good in 2 procedures. Four bleeding episodes were observed postoperatively; 3 were successfully managed with additional N8-GP doses and 1 case lacked evaluation. The average N8-GP dose on the day of surgery was 75.5 IU/kg, and the average number of doses was 1.7. Postoperative erythrocyte transfusion was required for 5 procedures.
All procedures in the pathfinder 5 study were performed without complications.
Conclusion
Based on the above experiences, turoctocog alfa pegol was effective in ensuring perioperative care in individuals with severe congenital hemophilia A, both for major and minor procedures.
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Source: Tosetto A., Neff A., Lentz S. R. et al. Turoctocog alfa pegol provides effective management for major and minor surgical procedures in patients across all age groups with severe haemophilia A: full data set from the pathfinder 3 and 5 phase III trials. Haemophilia 2020 May; 26 (3): 450–458, doi: 10.1111/hae.13980.
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