RT Journal Article
T1 BAY 81-8973 prophylaxis and pharmacokinetics in haemophilia A: Interim results from the TAURUS study.
A1 Santoro, Cristina
A1 Fuh, Beng
A1 Le, Phu Quoc
A1 Maes, Philip
A1 Berrueco, Ruben
A1 Mingot-Castellano, Eva Maria
A1 von-Mackensen, Sylvia
A1 Solms, Alexander
A1 Wang, Michael
K1 Coagulation disorders
K1 Haemophilia
K1 Pharmacokinetics
K1 Prophylaxis
K1 Real-world evidence
AB To report interim data from TAURUS, a study assessing real-world prophylactic treatment with unmodified, full-length recombinant FVIII BAY 81-8973 (Kovaltry® ; Bayer) indicated for haemophilia A. TAURUS (NCT02830477) is an international, open-label, prospective, non-interventional, single-arm study with a one-year observation period (target N = 350). Patients have moderate or severe haemophilia A (FVIII ≤5% or ≤1%) and ≥50 exposure days to any FVIII product. Clinician- and patient-reported outcomes are captured on previous product use, changes in prophylaxis dose and dosing frequency, FVIII consumption, reported bleeding rates, treatment satisfaction and adherence, pharmacokinetic (PK) data (if available) and safety data. At cut-off, baseline data were available from 160 patients (89 had ≥6 months of follow-up data). Most patients had severe haemophilia A (85%), infused BAY 81-8973 ≥ 3×/wk (59%) and experienced a median number of total bleeds of 2.0 (non-annualised; 246 days median documentation period). Good levels of treatment satisfaction (Hemo-SATA,P ) and adherence (VERITAS-Pro) were maintained. TAURUS demonstrated a favourable PK profile of BAY 81-8973 in comparison with other standard half-life rFVIIIs and supported the WAPPS PopPK model. No patients developed inhibitors. TAURUS data demonstrate effective prophylaxis with BAY 81-8973 in the real world without compromising patient satisfaction or adherence.
PB John Wiley & Sons
YR 2020
FD 2020-03-27
LK http://hdl.handle.net/10668/15337
UL http://hdl.handle.net/10668/15337
LA en
NO Santoro C, Fuh B, Le PQ, Maes P, Berrueco R, Mingot-Castellano EM, et al. BAY 81-8973 prophylaxis and pharmacokinetics in haemophilia A: Interim results from the TAURUS study. Eur J Haematol. 2020 Aug;105(2):164-172
DS RISalud
RD Apr 12, 2025