Evidence map›Paper›PMID 36192847›Full record

Trial reportEuropean journal of haematology2023

Efficacy and safety in patients with haemophilia A switching to octocog alfa (BAY 81-8973): Final results of the global real-world study, TAURUS.

Cristina Santoro, Beng Fuh, Phu Quoc Le, Philip Maes, Rubén Berrueco, Eva Maria Mingot-Castellano, Sylvia von Mackensen, Claudia Tueckmantel, Jose Francisco Cabre-Marquez, Michael Wang

Registry-linked trialOpen access · hybridAbstract readClinical Trial
In one paragraph

Trial report in European journal of haematology, 2023. 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 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
0.6field-weighted citation impact, top 29% 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

4 citing papers in PubMed, 4 citations in OpenAlex.

  1. Trial
  2. Article
  3. Single-arm clinical trials: design, ethics, principles.BMJ supportive & palliative care · 2024
    Review
  4. 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

10 authors at 10 institutions in 6 countries.

Cristina SantoroHematology, University Hospital, Policlinico Umberto I, Rome, Italy.ORCID https://orcid.org/0000-0002-7181-447X
Beng FuhEast Carolina University, Greenville, North Carolina, 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.ORCID https://orcid.org/0000-0001-9083-855X
Sylvia von MackensenDepartment of Medical Psychology, University Medical Centre Hamburg-Eppendorf, Hamburg, Germany.ORCID https://orcid.org/0000-0002-5926-0478
Claudia TueckmantelBayer, Wuppertal, Germany.
Jose Francisco Cabre-MarquezGlobal Medical Affairs, Bayer, Mexico City, Mexico.
Michael WangUniversity of Colorado, Aurora, Colorado, USA.
Antwerp University Hospital · BEBayer (Germany) · DEBayer (Mexico) · MXEast 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 the final results of the 2-year TAURUS study, assessing weekly prophylaxis dosing regimens of octocog alfa (Kovaltry®/BAY 81-8973) used in standard clinical practice in patients with moderate-to-severe haemophilia A.

methodsTAURUS (NCT02830477) is a phase 4, multinational, prospective, non-interventional, single-arm study in patients of any age with moderate or severe haemophilia A (≤5% factor [F]VIII activity). TAURUS was designed to primarily investigate weekly prophylaxis dosing regimens used in standard clinical practice. Annualised bleeding rates (ABRs), treatment satisfaction and adherence, and safety were also assessed.

resultsOf 302 patients included in the full analysis set, 84.4% (n = 255) maintained their octocog alfa prophylaxis baseline regimen throughout the study, with a majority of patients (76.5%, n = 231) on two times or three times weekly regimens at the end of the observation period (≥1-≤2 years). ABRs, treatment satisfaction, and adherence remained stable during the observation period. Octocog alfa was well tolerated and there were no new or unexpected adverse events.

conclusionsThese data show that a smooth transition is observed when switching to octocog alfa from a previous FVIII treatment, with no safety issues and stable bleeding rates in a real-world setting of patients with moderate-to-severe haemophilia A.

Indexed as

Hemophilia AFactor VIIIHemorrhageHumansProspective StudiesTreatment OutcomeF8 protein, humanFactor VIIIdrug switchinghaemophilia Aoctocog alfaprophylaxisprospective study

Identifiers

PMID36192847
PMCPMC10092432
OpenAlexW4301391123

What OpenQuestion holds

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LicenceCC BY-NC
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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.