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Despite hemophilia A advances, bleeds persist that can hold some patients back¹

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In a real-world study of patients with moderate-to-severe hemophilia A, the percentage of patients who experienced ≥1 bleed in first year of treatment¹:

^aAmong participants with ≥6 months of treatment exposure during Year 1, ABR was calculated based on bleed events data only.

Healthcare providers may refer to individual product labels for product-specific efficacy and other information. Data are descriptive, not head-to-head.

STUDY DESIGN¹:

Descriptive, observational cohort study in which eligible participants, including children and adults residing in the United States who were diagnosed with moderate to severe hemophilia A, were enrolled in the PicnicHealth database on or before October 3, 2022. Three cohorts were established to evaluate (1) treatment patterns between 2019 and 2022; (2) clinical outcomes by prophylactic therapy (SHL FVIII; EHL FVIII; FVIII mimetic); and (3) health-related quality of life (HRQoL) using the Patient-Reported Outcomes Measuring Instruments System (PROMIS)-29 survey and a supplemental pain survey. Patients switching treatment classes were included in multiple treatment groups. In the “clinical outcomes population,” 88 used EHL FVIII prophylaxis, 141 used SHL FVIII prophylaxis, and 82 used FVIII mimetic prophylaxis. Because patients who switched treatment classes were included in multiple treatment groups, cohorts were not mutually exclusive. As a retrospective medical record study, missing or incomplete documentation may have led to underestimation of treatment use, comorbidities, and bleeding events. ABR estimates based on discrete bleed events may also underestimate true bleeding rates due to potential underreporting.

ABR=annualized bleeding rate; EHL=extended half-life; FVIII=Factor VIII; SHL=standard half-life.

Many factors may contribute to ongoing bleeds. Patients may experience challenges with injections and infusions.^2,3 Patients may miss doses.³ Insufficient thrombin generation and weakened clot structure may also impact ongoing bleeds^4,5

THROMBIN GENERATION IS ESSENTIAL FOR ACHIEVING HEMOSTASIS⁶:

Lower thrombin generation was observed in more severe hemophilia and has been associated with a more severe bleeding phenotype⁶

Thrombogram of people with hemophilia A vs healthy control^6,b

^bThrombogram depicts thrombin generated in plasma during a 60-minute in vitro assay.

SUPPORTING THROMBIN GENERATION TOWARD PHYSIOLOGICAL LEVELS SUFFICIENT TO ACHIEVE EFFECTIVE CLOT FORMATION IS A CENTRAL GOAL OF HEMOPHILIA THERAPIES^6,7

How does lower thrombin activity impact clot stability?

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References:

1.	Wheeler AP, Amos LE, Gupta S, et al. Treatment of haemophilia A without inhibitors: real-world treatment patterns and clinical outcomes in the US. Haemophilia. 2026;32(3):760-771.
2.	Wheeler AP, Cibelli E, Hanson G, et al. Treatment and disease burden in a cohort of people with haemophilia without inhibitors in the United States. Haemophilia. 2025;31(5):912-921.
3.	Data on file. Novo Nordisk Inc; Plainsboro, NJ.
4.	Ząbczyk M, Natorska J, Undas A. Novel factors affecting fibrin clot formation and their clinical implications. Polish Archives of Internal Medicine. Published online November 6, 2024.
5.	Mihalko E, Brown AC. Clot structure and implications for bleeding and thrombosis. Semin Thromb Hemost. 2020;46(1):96-104.
6.	Sidonio RF Jr, Hoffman M, Kenet G, Dargaud Y. Thrombin generation and implications for hemophilia therapies: a narrative review. Res Pract Thromb Haemost. 2022;7(1):100018.
7.	Maneikis K, Krumb E, Hermans C. Normalization in hemophilia: conceptual foundations and clinical implications. Res Pract Thromb Haemost. 2025;9(7):103200.

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