Evidence map›Paper›PMID 34170499›Full record

ArticleDrugs - real world outcomes2021

Recombinant Factor VIII Fc Fusion Protein (rFVIIIFc) in Real Life: One-Year Clinical and Economic Outcomes.

Romain Giraud, Nicolas Delmotte, Sophie Gensollen, Martine Roche, Céline Falaise, Hervé Chambost, Manon Roche

Abstract read
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Article in Drugs - real world outcomes, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing 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

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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

4 citing papers in PubMed.

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4 · The record

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5 · Who and what money

Authors and funding

7 authors.

Romain GiraudPharmacie de la Conception, AP-HM, Marseille, France.
Nicolas DelmottePharmacie de la Conception, AP-HM, Marseille, France.
Sophie GensollenPharmacie de la Conception, AP-HM, Marseille, France.
Martine RocheCentre de Traitement de l'Hémophilie (CTH), AP-HM, Marseille, France.
Céline FalaiseCentre de Traitement de l'Hémophilie (CTH), AP-HM, Marseille, France.
Hervé ChambostCentre de Traitement de l'Hémophilie (CTH), AP-HM, Marseille, France.
Manon RocheService Central des Opérations Pharmaceutiques, AP-HM, Marseille, France. manon.roche@ap-hm.fr.ORCID http://orcid.org/0000-0001-9892-9173

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundRecombinant factor VIII Fc fusion protein (rFVIIIFc) is the first extended half-life (EHL) recombinant clotting factor with marketing authorization; it has been available in France since October 2016. However, data and literature about rFVIIIFc in clinical practice are scarce.

objectiveWe propose a 1-year clinical and economic outcome evaluation in patients with hemophilia A taking into consideration treatment adherence. PATIENTS AND

methodsWe reviewed the diaries of all patients treated with rFVIIIFc at Marseille Hemophilia Center for 1 year. All the data were related to the patients' infusion (i.e., annual number of infusions, weekly dose/kg, and annual consumption) and bleeding reports. The clotting factor costs were considered, whereas additional costs (e.g., infusion devices and nurse intervention) were neglected.

resultsA total of 34 patients were evaluated. Their median age was 18 years (IQR = 18). Treatment adherence was observed in 62% for FVIII and 66% for rFVIIIFc. The analysis revealed a negligible decrease in the annual clotting factor consumption following the switch (- 2%, p = 0.7339). These data were combined with a significant reduction in the annual number of infusion (- 22.5%, median = 138.5, IQR = 65.8 for FVIII; median = 105, IQR = 24 for rFVIIIFc, p < 0.0001) and bleeding (- 50%, median = 5, IQR = 7.5 for FVIII; median = 1, IQR = 4 for rFVIIIFc, p < 0.0001). With regard to the cost, a decreasing trend was observed (- 8%, p = 0.1300).

conclusionThe analysis in a real-life setting revealed that the input of switches toward rFVIIIFc in different treatment (age of patients and regimen) patterns seems to corroborate previous studies. The results suggest that switches have a beneficial effect in terms of efficacy, clotting factor consumption, and cost.

Identifiers

PMID34170499
PMCPMC8605945

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