ISTH Congress Abstracts

Official abstracts site for the ISTH Congress

MENU 
  • Home
  • Congress Archive
    • ISTH 2022 Congress
    • ISTH 2021 Congress
    • ISTH 2020 Congress
  • Resources
  • Search

BAY 81-8973 prophylaxis in Patients with Hemophilia A: Interim Usage and Safety Results from the TAURUS Real-World Study

C. Santoro1, M. Wang2, B. Fuh3, P. Maes4, M.E. Mingot-Castellano5, R. Berrueco6, E. Detering7, J.F. Cabre Marquez8, P.Q. Lê9

1Hematology, Policlinico Umberto I Hospital, Rome, Italy, 2University of Colorado, Aurora, United States, 3East Carolina University, Greenville, United States, 4University Hospital of Antwerp, Edegem, Belgium, 5Regional University Hospital Carlos Haya, Division of Hematology, Málaga, Spain, 6Sant Joan de Déu Children's Hospital, Barcelona, Spain, 7Bayer, Berlin, Germany, 8Bayer, Mexico City, Mexico, 9Queen Fabiola Children's University Hospital, Brussels, Belgium

Abstract Number: PB0870

Meeting: ISTH 2020 Congress

Theme: Hemophilia and Rare Bleeding Disorders » Hemophilia - Clinical

Background: BAY 81-8973 (Kovaltry®) is an unmodified, full length, recombinant factor VIII (FVIII) indicated for prophylaxis and treatment of bleeds in patients with hemophilia A. Safety and efficacy were established in the LEOPOLD clinical trials.

Aims: To highlight interim findings on the real-world usage and safety of BAY 81-8973 from the TAURUS study.

Methods: TAURUS (NCT02830477) is an international, open-label, prospective, non-interventional study enrolling patients of all ages with moderate/severe hemophilia A (FVIII ≤5% or ≤1%) and ≥50 exposure days to any FVIII, receiving BAY 81‑8973 prophylaxis in standard clinical practice. This interim analysis reports switching behavior and safety.

Results: At data cutoff (June 2019), 264 patients had received ≥1 prophylactic dose of BAY 81-8973. The median age at baseline was 25.0 years (97.3% were previously treated with FVIII). 191 patients fulfilled inclusion criteria and had ≥1 follow-up assessment after receiving BAY 81-8973. At baseline, 60.7% received prophylaxis >2.5×/week and 36.6% received prophylaxis ≤2.5×/week (data missing for 5 patients). Three patients switched from ≤2.5×/week at baseline to >2.5×/week at cutoff; eight patients switched from >2.5×/week to ≤2.5×/week. The most frequent reason for the initial switch to BAY 81-8973 was “physician decision” (61.8%); reasons for initial dose/dosing frequency are shown in

Figure 1. The median prescribed weekly dose was 56.9 IU/kg.
The safety population included 263 patients. 22.1% experienced an adverse event (AE): all were treatment emergent and none were related to inhibitor development or positive inhibitor measurement. One AE (pruritis in one patient) was drug-related and led to discontinuation of BAY 81-8973. No other AEs were drug-related. Serious AEs were reported in 20 patients (7.6%), but none were drug-related.


[Figure 1: Reasons for initial dose/dosing frequency]

Conclusions: Data analyzed in this interim report confirm a reassuring safety profile and indicate that prophylaxis regimens before and after initiation of BAY 81-8973 were similar and remained stable during the treatment period.

To cite this abstract in AMA style:

Santoro C, Wang M, Fuh B, Maes P, Mingot-Castellano ME, Berrueco R, Detering E, Cabre Marquez JF, Lê PQ. BAY 81-8973 prophylaxis in Patients with Hemophilia A: Interim Usage and Safety Results from the TAURUS Real-World Study [abstract]. Res Pract Thromb Haemost. 2020; 4 (Suppl 1). https://abstracts.isth.org/abstract/bay-81-8973-prophylaxis-in-patients-with-hemophilia-a-interim-usage-and-safety-results-from-the-taurus-real-world-study/. Accessed October 1, 2023.

« Back to ISTH 2020 Congress

ISTH Congress Abstracts - https://abstracts.isth.org/abstract/bay-81-8973-prophylaxis-in-patients-with-hemophilia-a-interim-usage-and-safety-results-from-the-taurus-real-world-study/

Simple Search

Supported By:

Takeda logo

ISTH 2022 Congress site

Visit the official web site for the ISTH 2022 Virtual Congress »

  • Help & Support
  • About Us
  • Cookies & Privacy
  • Wiley Job Network
  • Terms & Conditions
  • Advertisers & Agents
Copyright © 2023 John Wiley & Sons, Inc. All Rights Reserved.
Wiley