BAY 81‐8973 prophylaxis and pharmacokinetics in haemophilia A: Interim results from the TAURUS study

Objectives 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. Methods TAURUS (NCT02830477) is an international, open‐label, prospective, non‐interventional,...

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Published in:European journal of haematology 2020-08, Vol.105 (2), p.164-172
Main Authors: Santoro, Cristina, Fuh, Beng, Le, Phu Quoc, Maes, Philip, Berrueco, Rubén, Mingot‐Castellano, Eva Maria, von Mackensen, Sylvia, Solms, Alexander, Wang, Michael
Format: Article
Language:English
Subjects:
coagulation disorders
Dosage
haemophilia
Hemophilia
Original
Patient satisfaction
Pharmacokinetics
Prophylaxis
real‐world evidence
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cited_by cdi_FETCH-LOGICAL-c4430-3afbd476c986313691c2de9b11a818768695ee3fcdea110d24fbd32a941a1bec3
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container_issue 2
container_start_page 164
container_title European journal of haematology
container_volume 105
creator Santoro, Cristina
Fuh, Beng
Le, Phu Quoc
Maes, Philip
Berrueco, Rubén
Mingot‐Castellano, Eva Maria
von Mackensen, Sylvia
Solms, Alexander
Wang, Michael
description Objectives 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. Methods 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. Results 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. Conclusions TAURUS data demonstrate effective prophylaxis with BAY 81‐8973 in the real world without compromising patient satisfaction or adherence.
doi_str_mv 10.1111/ejh.13420
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Methods 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. Results 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. Conclusions TAURUS data demonstrate effective prophylaxis with BAY 81‐8973 in the real world without compromising patient satisfaction or adherence.</description><identifier>ISSN: 0902-4441</identifier><identifier>EISSN: 1600-0609</identifier><identifier>DOI: 10.1111/ejh.13420</identifier><identifier>PMID: 32259334</identifier><language>eng</language><publisher>England: Wiley Subscription Services, Inc</publisher><subject>coagulation disorders ; Dosage ; haemophilia ; Hemophilia ; Original ; Patient satisfaction ; Pharmacokinetics ; Prophylaxis ; real‐world evidence</subject><ispartof>European journal of haematology, 2020-08, Vol.105 (2), p.164-172</ispartof><rights>2020 The Authors. published by John Wiley &amp; Sons Ltd.</rights><rights>2020 The Authors. 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Methods 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. Results 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. 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subjects coagulation disorders
Dosage
haemophilia
Hemophilia
Original
Patient satisfaction
Pharmacokinetics
Prophylaxis
real‐world evidence
title BAY 81‐8973 prophylaxis and pharmacokinetics in haemophilia A: Interim results from the TAURUS study
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