Abstract
In recent decades, hemophilia A treatment has been focused on body weight, without taking pharmacokinetic parameters into account. Previous research has shown that the individual pharmacokinetic response is more effective in predicting the required dose of clotting factor. We want to evaluate the impact on reducing the frequency of bleeding in patients treated with recombinant factor VIII, based on a personalized comprehensive management program. Our aim was to compare the results of a standard comprehensive treatment program (stage I) vs. a personalized pharmacokinetic - based treatment program (stage II) in a cohort of 60 patients with severe hemophilia without inhibitors. The median age was 15.5 years (3-68). The annual bleeding rate (ABR) was 1.03 (62 episodes) in the first stage and 0.58 (35 episodes) in the second one, (p=0.004). By type of bleeding, the impact of the intervention differs significantly in spontaneous bleeding (p=0.007) and a 73% reduction in the first stage. There were no significant differences in traumatic bleeding. The use of pharmacokinetics (PK) for personalized dosing of patients with severe hemophilia A, significantly reduces ABR and spontaneous bleeding, improving the patient’s quality of life and costs for the health system.
Highlights
II) in a cohort of 60 patients with severe m hemophilia without inhibitors
Patients were eligible for the study if they fulfilled the inclusion criteria: diagnosis of severe hemophilia A (FVIII:
The use of pharma- of drug was kept for at least 12 months), the cokinetics (PK) for personalized dosing of patients with severe hemophilia A, signifidata of PK were calculated from the WAPPS-Hemo computer application,[19] cantly reduces ABR and spontaneous bleed- availability of complete medical records to tive analysis of the sociodemographic and ing, improving the patient’s quality of life analyze demographics and clinical evolu- clinical variables
Summary
We carried out a descriptive, longitudinal study of a single cohort of 60 patients in a health care institution in Bogotà, Colombia, between 2017 and 2019. The use of pharma- of drug was kept for at least 12 months), the cokinetics (PK) for personalized dosing of patients with severe hemophilia A, signifidata of PK were calculated from the WAPPS-Hemo computer application,[19] cantly reduces ABR and spontaneous bleed- availability of complete medical records to tive analysis of the sociodemographic and ing, improving the patient’s quality of life analyze demographics and clinical evolu- clinical variables. 31 patients were all those who met the inclu- the median FVIII was 34.0 IU, at 12 hours patients (51.7%) had no bleeding episodes sion criteria. Bleeding episodes, while 25 patients the data found in the medical record against. Teria, ensuring that the data of the variables State are valid and there was a sufficient sample
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