Evidence map›Paper›PMID 39434416›Full record

Observational studyEuropean journal of haematology2025

Superior Prophylactic Effectiveness of a Recombinant FVIIIFc Over Standard Half-Life FVIII in Hemophilia A: A-SURE Study.

Johannes Oldenburg, Charles Hay, Flora Peyvandi, Annarita Tagliaferri, Pål Andrè Holme, María Teresa Álvarez-Román, Christine Biron-Andréani, Håkan Malmström, Linda Bystrická, Stefan Lethagen and 1 more

Abstract readMulticenter StudyObservational Study
In one paragraph

Observational study in European journal of haematology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Article
  2. Article
  3. Clinical and Surgical Experiences with Efmoroctocog Alfa in Pediatric Population with Hemophilia A.Clinical and applied thrombosis/hemostasis : official journal of the International Academy of Clinical and Applied Thrombosis/Hemostasis
    Observational
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

11 authors.

Johannes OldenburgInstitute of Experimental Hematology and Transfusion Medicine, University Hospital Bonn, Medical Faculty, University of Bonn, Bonn, Germany.
Charles HayUniversity Department of Haematology, Manchester Royal Infirmary, Manchester, UK.
Flora PeyvandiAngelo Bianchi Bonomi Hemophilia and Thrombosis Center and Fondazione Luigi Villa, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico, Milan, Italy.
Annarita TagliaferriRegional Reference Center for Inherited Bleeding Disorders, University Hospital of Parma, Parma, Italy.
Pål Andrè HolmeDepartment of Haematology, Oslo University Hospital, Institute of Clinical Medicine, University of Oslo, Oslo, Norway.
María Teresa Álvarez-RománDepartment of Haematology, La Paz University Hospital-IdiPaz, Madrid, Spain.
Christine Biron-AndréaniHaemophilia Treatment Centre, Department of Biological Haematology, University Hospital Montpellier, Montpellier, France.
Håkan MalmströmObservational Research, Sobi, Stockholm, Sweden.
Linda BystrickáGlobal Medical Affairs and Clinical Development, Sobi, Stockholm, Sweden.
Stefan LethagenGlobal Medical Affairs and Clinical Development, Sobi, Stockholm, Sweden.
A‐SURE Study Group

Funding

Sobi
6 · The paper itself

Abstract

objectivesThe 24-month, prospective, non-interventional, European multicenter A-SURE study evaluated the real-world effectiveness of prophylaxis using an extended half-life recombinant factor VIII (FVIII) Fc fusion protein, efmoroctocog alfa (hereinafter rFVIIIFc), compared with prophylaxis using standard half-life (SHL) FVIII products in patients with hemophilia A.

methodsPrimary endpoints were annualized bleeding rate (ABR), annualized injection frequency, and annualized factor consumption. A comparative study design unique for an observational hemophilia study was implemented to reduce potential confounding in effectiveness estimates, wherein each patient prescribed rFVIIIFc was matched with one receiving SHL FVIII. Propensity scores were used for adjustment in statistical analyses.

resultsOutcomes for all primary endpoints were significantly better in the rFVIIIFc group (n = 184) compared with the SHL FVIII group (n = 170): mean ABR 1.5 versus 2.3 (difference of -0.8; p = 0.0147); mean annualized injection frequency 114.4 versus 169.2 (difference of -54.8; p < 0.0001); and mean annualized factor consumption 243 024.2 versus 288 718.6 International Units (difference of 45 694.5; p = 0.0003). rFVIIIFc was well tolerated, with no inhibitor development.

conclusionsrFVIIIFc has superior prophylactic effectiveness versus SHL FVIII, providing higher bleed protection with fewer injections and lower factor consumption.

Indexed as

Factor VIIIHemophilia ARecombinant Fusion ProteinsAdolescentAdultChildChild, PreschoolFemaleHalf-LifeHemorrhageHumansImmunoglobulin Fc FragmentsMaleMiddle AgedProspective StudiesTreatment OutcomeFactor VIIIfactor VIII-Fc fusion proteinImmunoglobulin Fc FragmentsRecombinant Fusion Proteinsfactor VIIIhemophilia Apropensity scoreprospective study

Identifiers

PMID39434416
PMCPMC11707817

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Registered trials

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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.