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

Abstract : Background: Recombinant 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. Objective: We propose a 1-year clinical and economic outcome evaluation in patients with hemophilia A taking into consideration treatment adherence. Patients and methods: We 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. Results: A 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). Conclusion: The 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.
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https://hal-amu.archives-ouvertes.fr/hal-03653429
Contributor : GUILLAUME RANCHON Connect in order to contact the contributor
Submitted on : Wednesday, April 27, 2022 - 5:28:34 PM
Last modification on : Wednesday, May 4, 2022 - 3:44:02 AM

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Romain Giraud, Nicolas Delmotte, Sophie Gensollen, Martine Roche, Céline Falaise, et al.. Recombinant Factor VIII Fc Fusion Protein (rFVIIIFc) in Real Life: One-Year Clinical and Economic Outcomes. Drugs - Real World Outcomes, 2021, 8 (4), pp.527-535. ⟨10.1007/s40801-021-00259-2⟩. ⟨hal-03653429⟩

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