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

Autor:	Beng Fuh, Eva Maria Mingot‐Castellano, Philip Maes, Phu Quoc Lê, Sylvia von Mackensen, Alexander Solms, Michael Wang, Rubén Berrueco, Cristina Santoro
Jazyk:	angličtina
Rok vydání:	2020
Předmět:	Adult Male medicine.medical_specialty Adolescent Haemophilia A haemophilia Hemorrhage Clinical Trials Phase IV as Topic Hemophilia A Haemophilia Chemoprevention Severity of Illness Index Young Adult Patient satisfaction Pharmacokinetics Internal medicine Interim Humans Medicine Patient Reported Outcome Measures real-world evidence Factor VIII business.industry Hematology General Medicine Baseline data Original Articles real‐world evidence medicine.disease Recombinant Proteins Treatment Outcome coagulation disorders Original Article Human medicine prophylaxis business Bay Dosing Frequency pharmacokinetics
Zdroj:	European Journal of Haematology European journal of haematology
ISSN:	1600-0609 0902-4441 0283-0477
Popis:	Objectives To report interim data from TAURUS, a study assessing real-world prophylactic treatment with unmodified, full-length recombinant FVIII BAY 81-8973 (Kovaltry(R); 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 = 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 >= 3x/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-SAT(A,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.
Databáze:	OpenAIRE
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