Elena Santagostino1, Shadan Lalezari2, Mark T Reding3, Jonathan Ducore4, Heng Joo Ng5, Lone H Poulsen6, Lisa A Michaels7, Camila C G Linardi8. 1. Foundation IRCCS Ca' Granda, Maggiore Hospital Policlinico, Milan, Italy. 2. Israel National Hemophilia Center, Chaim Sheba Medical Center, Tel Hashomer, Israel; Sackler School of Medicine, Tel-Aviv University, Israel. 3. Center for Bleeding and Clotting Disorders, University of Minnesota Medical Center, Minneapolis, MN, United States of America. 4. Hemophilia Treatment Center, UC Davis Medical Center, Sacramento, CA, United States of America. 5. Department of Haematology, Singapore General Hospital, Singapore. 6. The Haemophilia Centre, Aarhus University Hospital, Aarhus, Denmark. 7. Bayer, Whippany, NJ, United States of America. 8. Bayer, Whippany, NJ, United States of America. Electronic address: camila.linardi@bayer.com.
Abstract
INTRODUCTION: Ensuring hemostasis during invasive procedures is a challenge in patients with severe hemophilia A. This analysis evaluated efficacy and safety of BAY 94-9027, an extended-half-life recombinant factor VIII (FVIII), in the surgical setting. MATERIALS AND METHODS: Patients participating in an open-label BAY 94-9027 clinical trial who underwent major surgery were included in the analysis. Investigator/surgeon assessment of hemostasis during surgery was the primary outcome. In addition, information about FVIII use, FVIII levels during perioperative period, bleeding complications and FVIII inhibitor development were collected. RESULTS: Data were analyzed for 26 major surgeries (orthopedic, n = 21) in 20 patients aged 13-61 years. BAY 94-9027 provided effective hemostasis during all procedures. FVIII levels 6-8 h post preoperative infusion and prior to the first follow-up infusion were in the range expected to maintain protection in the major surgery setting. The median time from preoperative infusion to the first follow-up infusion (the first infusion administered after the preoperative infusion) was 12.33 (3.6-49.9) h. No intraoperative bleeding complications occurred, and no new inhibitors developed following any surgery. CONCLUSIONS: The results of the study demonstrate that BAY 94-9027 was efficacious and well tolerated in the treatment of patients undergoing major surgeries. Advantages of BAY 94-9027 include the potential for less frequent infusion and reduced factor consumption, which should simplify the management of patients during major surgery.
INTRODUCTION: Ensuring hemostasis during invasive procedures is a challenge in patients with severe hemophilia A. This analysis evaluated efficacy and safety of BAY 94-9027, an extended-half-life recombinant factor VIII (FVIII), in the surgical setting. MATERIALS AND METHODS:Patients participating in an open-label BAY 94-9027 clinical trial who underwent major surgery were included in the analysis. Investigator/surgeon assessment of hemostasis during surgery was the primary outcome. In addition, information about FVIII use, FVIII levels during perioperative period, bleeding complications and FVIII inhibitor development were collected. RESULTS: Data were analyzed for 26 major surgeries (orthopedic, n = 21) in 20 patients aged 13-61 years. BAY 94-9027 provided effective hemostasis during all procedures. FVIII levels 6-8 h post preoperative infusion and prior to the first follow-up infusion were in the range expected to maintain protection in the major surgery setting. The median time from preoperative infusion to the first follow-up infusion (the first infusion administered after the preoperative infusion) was 12.33 (3.6-49.9) h. No intraoperative bleeding complications occurred, and no new inhibitors developed following any surgery. CONCLUSIONS: The results of the study demonstrate that BAY 94-9027 was efficacious and well tolerated in the treatment of patients undergoing major surgeries. Advantages of BAY 94-9027 include the potential for less frequent infusion and reduced factor consumption, which should simplify the management of patients during major surgery.
Authors: Pratima Chowdary; Margareta Holmström; Johnny N Mahlangu; Margaret C Ozelo; Ingrid Pabinger; K John Pasi; Margaret V Ragni; Amy Shapiro; Chris Barnowski; Stefan Lethagen Journal: Res Pract Thromb Haemost Date: 2022-07-26