Safety and efficacy of BAY 94-9027, an extended-half-life factor VIII, during surgery in patients with severe hemophilia A: Results of the PROTECT VIII clinical trial

Elena Santagostino, Shadan Lalezari, Mark T. Reding, Jonathan Ducore, Heng Joo Ng, Lone H. Poulsen, Lisa A. Michaels, Camila C.G. Linardi

Research output: Contribution to journalArticlepeer-review

9 Scopus citations

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.

Original languageEnglish (US)
Pages (from-to)13-19
Number of pages7
JournalThrombosis Research
Volume183
DOIs
StatePublished - Nov 2019
Externally publishedYes

Bibliographical note

Funding Information:
The authors would like to thank Maria Wang (Bayer) for providing statistical support, and Anita Shah (Bayer) and Yvonne Katterle (Bayer) for providing pharmacokinetics data. This analysis and the PROTECT VIII main study were funded by Bayer. Medical writing assistance was provided by Ken Wannemacher, PhD, from Complete Healthcare Communications, LLC (West Chester, PA, USA) and Graeme Baldwin from Darwin Healthcare Communications (London, UK) and was funded by Bayer.

Funding Information:
The authors would like to thank Maria Wang (Bayer) for providing statistical support, and Anita Shah (Bayer) and Yvonne Katterle (Bayer) for providing pharmacokinetics data. This analysis and the PROTECT VIII main study were funded by Bayer . Medical writing assistance was provided by Ken Wannemacher, PhD, from Complete Healthcare Communications, LLC (West Chester, PA, USA) and Graeme Baldwin from Darwin Healthcare Communications (London, UK) and was funded by Bayer.

Publisher Copyright:
© 2019 The Authors

Keywords

  • Extended-half-life factor VIII
  • Hemophilia A
  • Recombinant protein
  • Surgery

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