Evidence map›Paper›PMID 32259334›Full record

ArticleEuropean journal of haematology2020

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

Cristina Santoro, Beng Fuh, Phu Quoc Le, Philip Maes, Rubén Berrueco, Eva Maria Mingot-Castellano, Sylvia von Mackensen, Alexander Solms, Michael Wang

Registry-linked trialOpen access · greenAbstract read
In one paragraph

Article in European journal of haematology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02830477 (A Multinational Phase IV Study Evaluating "Real World" Treatment Pattern in Previously Treated Hemophilia A Patients Receiving KOVALTRY), which is not on this map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
0.4field-weighted citation impact, top 38% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02830477 completednot on this map

A Multinational Phase IV Study Evaluating "Real World" Treatment Pattern in Previously Treated Hemophilia A Patients Receiving KOVALTRY (Octocog Alfa) for Routine Prophylaxis

TypeobservationalSponsorBayerRan2016 to 2021Enrolled313ConditionsHemophilia A, CongenitalArmsKovaltry (Antihemophilic Factor [Recombinant], BAY81-8973
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 7 citations in OpenAlex.

  1. Trial
  2. Article
  3. Article
  4. Article
  5. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors at 9 institutions in 5 countries.

Cristina SantoroHematology, Department of Translational and Precision Medicine, Policlinico Umberto I, Sapienza University, Rome, Italy.ORCID https://orcid.org/0000-0002-7181-447X
Beng FuhEast Carolina University, Greenville, NC, USA.
Phu Quoc LeQueen Fabiola Children's University Hospital, Brussels, Belgium.
Philip MaesUniversity Hospital of Antwerp, Edegem, Belgium.
Rubén BerruecoHospital Sant Joan de Déu, Barcelona University, Barcelona, Spain.
Eva Maria Mingot-CastellanoHospital Regional Universitario de Málaga, Málaga, Spain.
Sylvia von MackensenDepartment of Medical Psychology, University Medical Centre Hamburg-Eppendorf, Hamburg, Germany.
Alexander SolmsBayer, Berlin, Germany.
Michael WangUniversity of Colorado, Aurora, CO, USA.
Antwerp University Hospital · BEBayer (Germany) · DEEast Carolina University · USHospital Regional Universitario de Málaga · ESHospital Sant Joan de Déu Barcelona · ESPoliclinico Umberto I · ITQueen Fabiola Children's University Hospital · BEUniversität Hamburg · DEUniversity of Colorado Anschutz Medical Campus · US

Funding

Bayer
6 · The paper itself

Abstract

objectivesTo report interim data from TAURUS, a study assessing real-world prophylactic treatment with unmodified, full-length recombinant FVIII BAY 81-8973 (Kovaltry

methodsTAURUS (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.

resultsAt 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-SAT

conclusionsTAURUS data demonstrate effective prophylaxis with BAY 81-8973 in the real world without compromising patient satisfaction or adherence.

Indexed as

AdolescentAdultChemopreventionClinical Trials, Phase IV as TopicFactor VIIIHemophilia AHemorrhageHumansMalePatient Reported Outcome MeasuresRecombinant ProteinsSeverity of Illness IndexTreatment OutcomeYoung AdultF8 protein, humanFactor VIIIRecombinant Proteinscoagulation disordershaemophiliapharmacokineticsprophylaxisreal-world evidence

Identifiers

PMID32259334
PMCPMC7497079
OpenAlexW3014098219

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.