Safety and efficacy of BAY 81-8973 for surgery in previously treated patients with haemophilia A: Results of the LEOPOLD clinical trial programme

Abstract

Introduction: BAY 81-8973 is a recombinant factor VIII (rFVIII) with the same amino acid sequence as Bayer's sucrose-formulated rFVIII (rFVIII-FS) but manufactured with certain more advanced technologies. Aim: To describe surgery outcomes with BAY 81-8973 in the LEOPOLD trials. Methods: Male patients with severe haemophilia A and no inhibitors aged 12-65 years with ≥150 exposure days (EDs) to FVIII (LEOPOLD I and II), or aged ≤12 years with ≥50 EDs to FVIII (LEOPOLD Kids), received BAY 81-8973 based on dosing recommendations for rFVIII-FS according to surgical requirements. Haemostasis-related complications, investigator/surgeon assessment of haemostasis, blood loss, need for transfusion and use of BAY 81-8973 were determined. Results: In LEOPOLD I and II, 11 patients (mean age, 35.3 years) underwent 13 major surgeries. In LEOPOLD Kids, one patient (aged 6 years) underwent one major surgery. Thirty-two adult and paediatric patients underwent 46 minor surgeries. Haemostasis was rated good or excellent in all major and minor surgeries. Blood loss during surgery did not exceed expected amounts; blood transfusions were required in three of the 14 major surgeries. For major surgeries in LEOPOLD I and II, patients received a presurgical 50-IU kg-1 dose of BAY 81-8973; median nominal dose on day of surgery was 7000 IU (107.5 IU kg-1). Total BAY 81-8973 dose was 2500 IU (108.7 IU kg-1) on the day of the only major surgery in LEOPOLD Kids. No haemostasis-related complications were reported. Conclusions: Haemostatic control with BAY 81-8973 during all surgeries in the LEOPOLD trials was good or excellent, with no haemostasis-related complications.