PB0681 - German experience with simoctocog alfa during surgery in female haemophilia A carriers

Monday, June 26, 2023

18:30 – 19:30 ET

Room: Exhibition

Presenting Author(s)

Natascha Marquardt, MD

Senior Physician
Institute for Experimental Hematology and Transfusion Medicine, University Clinic Bonn
Bonn, Nordrhein-Westfalen, Germany

Co-Author(s)

Johannes Oldenburg, MD (he/him/his)

Professor, Chairman and Director
University Clinic Bonn AöR, Institute of Experimental Haematology and Transfusion Medicine, Bonn, Germany
Bonn, Nordrhein-Westfalen, Germany

Background: Data on the efficacy of factor VIII (FVIII) concentrates in female haemophilia A carriers are lacking, with clinical trials predominantly including male patients with severe disease. There is growing evidence that female haemophilia A carriers may experience bleeding symptoms and require additional haemostatic coverage. Improved evidence-based treatment guidelines for female haemophilia A carriers are needed.

Aims: To assess the efficacy of simoctocog alfa (Nuwiq®), a recombinant FVIII concentrate, for achieving haemostasis during surgery in female haemophilia A carriers.

Methods: A retrospective case series was collated of all female haemophilia A carriers prescribed simoctocog alfa at the Bonn Haemophilia Centre between 2014–2022. Data on haemostatic coverage with simoctocog alfa during surgery were collected. Haemostatic efficacy was deemed achieved if the blood loss volume was as expected for that type of surgery and/or no bleeding complications were reported.

Results: From 2014–2022, 51 female haemophilia A carriers were prescribed simoctocog alfa at the centre. Simoctocog alfa was used for haemostatic coverage during 33 surgeries in 26 patients; 7 surgeries were classified as major and 26 minor. Median (range) baseline FVIII activity was 48(15–81) and age at time of surgery was 40 (5–83). Median (range) duration of simoctocog alfa treatment for surgery was 2 (1–22) days and median (range) total simoctocog alfa dose was 53 (20–312) IU/kg. In 32/33 (97%) surgeries, haemostatic efficacy of simoctocog alfa was achieved. For the remaining surgery (caesarean section), haemostatic efficacy could not be assessed due to the development of atony where the resulting blood loss for a caesarean section was (as expected) exceeded. No inhibitors developed in any patient despite intensive FVIII treatment.

Conclusion(s): Clinical experience in our centre shows that simoctocog alfa is efficacious for haemostatic coverage during surgery in female haemophilia A carriers, with no development of FVIII inhibitors.