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Risk of Intracranial Hemorrhage in Persons with Hemophilia A in the United States: Real-World Retrospective Cohort Study Using the ATHNdataset.
Hu, Jianzhong; Chandler, Martin; Manuel, Christopher Matthew; Caicedo, Jorge; Denne, Michael; Ewenstein, Bruce; Mokdad, Ali G; Xing, Shan; Recht, Michael.
Afiliación
  • Hu J; American Thrombosis and Hemostasis Network, Rochester, NY, USA.
  • Chandler M; American Thrombosis and Hemostasis Network, Rochester, NY, USA.
  • Manuel CM; American Thrombosis and Hemostasis Network, Rochester, NY, USA.
  • Caicedo J; Rare Diseases and Hematology, Takeda Pharmaceuticals, U.S.A., Inc, Lexington, MA, USA.
  • Denne M; Rare Diseases and Hematology, Takeda Pharmaceuticals, U.S.A., Inc, Lexington, MA, USA.
  • Ewenstein B; Rare Diseases and Hematology, Takeda Pharmaceuticals, U.S.A., Inc, Lexington, MA, USA.
  • Mokdad AG; Rare Diseases and Hematology, Takeda Pharmaceuticals, U.S.A., Inc, Lexington, MA, USA.
  • Xing S; US Value and Evidence Generation, Takeda Pharmaceuticals, U.S.A., Inc, Lexington, MA, USA.
  • Recht M; American Thrombosis and Hemostasis Network, Rochester, NY, USA.
J Blood Med ; 15: 191-205, 2024.
Article en En | MEDLINE | ID: mdl-38699197
ABSTRACT

Introduction:

Intracranial hemorrhage (ICH), a serious complication in persons with hemophilia A (PWHA), causes high rates of mortality and morbidity. Identified ICH risk factors from patient data spanning 1998-2008 require reassessment in light of changes in the current treatment landscape. Aim and

methods:

PWHA identified in the ATHNdataset were evaluated retrospectively to assess incidence of ICH and determine the association between ICH risk and key characteristics using time-to-event analyses (Cox proportional-hazards models, survival curves, and sensitivity analyses).

Results:

Over a median follow-up time of 10.7 patient-years, 135 of 7837 PWHA over 2 years of age in the ATHNdataset (1.7%) experienced an ICH. Stratification by prophylaxis status and inhibitor status resulted in an incidence rate (IR) ratio (IRR) (IR+/IR-) of 0.63 (95% confidence interval [CI], 0.43-0.94; P=0.020) and 1.76 (95% CI, 0.97-3.20; P=0.059), respectively. Characteristics associated with greater risk of developing ICH include being aged 2-12 years; being covered by Medicaid; having had HIV, hepatitis C, or hypertension; and never having received factor VIII or prophylactic treatment. In multivariable analysis with interaction, the estimated hazard ratio for PWHA never receiving prophylaxis was 7.67 (95% CI, 2.24-26.30), which shrunk to 2.03 (95% CI, 1.30-9.12) in bootstrapping analysis and 3.09 in the highest-penalty ridge-regression analysis but was still significant. Inhibitor status was found not to be statistically associated with ICH in all analyses.

Conclusion:

These results align with previous studies demonstrating that prophylaxis confers a protective effect against ICH. Previously, inhibitor positivity had been shown to increase risk for ICH; however, this study did not corroborate those findings.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Idioma: En Revista: J Blood Med Año: 2024 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Nueva Zelanda
Texto completo
Añadir a Mi BVS
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Idioma: En Revista: J Blood Med Año: 2024 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Nueva Zelanda