Blood Res.  2024;59:29. 10.1007/s44313-024-00023-9.

Evaluation of FVIII pharmacokinetic profiles in Korean hemophilia A patients assessed with myPKFiT: a retrospective chart review

Affiliations
  • 1Department of Pediatrics, Kyung Hee University Hospital, Gangdong, Seoul, Republic of Korea
  • 2Korea Hemophilia Foundation Clinic, Seoul, Republic of Korea
  • 3Korea Hemophilia Foundation Clinic, Busan, Republic of Korea
  • 4Korea Hemophilia Foundation Clinic, Gwangju, Republic of Korea
  • 5Medical Affairs, Takeda Pharmaceuticals Korea Co., Ltd, Seoul, Republic of Korea
  • 6Department of Pediatrics, Daegu Catholic University Medical Center, 33 Duryugongwon‑Ro 17‑Gil, Nam‑Gu, Daegu 42472, Republic of Korea

Abstract

Purpose
This study aimed to investigate the pharmacokinetics (PK) of factor VIII (FVIII) in Korean patients, as limited information is available on the PK of FVIII in this population.
Methods
We collected the FVIII PK results from patients with moderate-to-severe hemophilia A using myPKFiT. PK variations were assessed according to age, blood type, inhibitor history, von Willebrand factor antigen (vWF:Ag) level, and body mass index. Additionally, the correlation between the PK profile and prophylaxis regimen was specifically analyzed for each product in severe cases.
Results
The PK data of 48 and 81 patients treated with octocog alfa and rurioctocog alfa pegol, respectively, were obtained. The median half-lives of octocog alfa and rurioctocog alfa pegol were 9.9 (range: 6.3–15.2) h and 15.3 (range: 10.4–23.9) h, respectively. The PK profiles for each product did not differ according to age group; however, blood type-O patients had shorter half-lives and time to 1% compared to non-blood type-O patients. In regression analysis, the PK of octocog alfa showed a statistically significant difference according to age, whereas the PK of ruri‑ octocog alfa pegol correlated with vWF:Ag. Only the frequency of rurioctocog alfa pegol use showed a statistically significant difference in relation to time to 1%, although the coefficient of determination was small.
Conclusion
This study confirmed significant interpatient variation in the PK of FVIII among Korean patients with hemophilia A. To achieve optimized prophylaxis, personalizing the regimen based on the PK profile of each individual patient is essential.

Keyword

Hemophilia A; FVIII; Pharmacokinetics; Prophylaxis; Korean

Figure

  • Fig. 1 Distribution of dose and frequency by quartiles of time to 1%. A Dose (IU/kg) of octocog alfa; (B) dose of rurioctocog alfa pegol; (C) frequency (injections per week) of octocog alfa; and (D) frequency of rurioctocog alfa pegol. The box in the plot represents the interquartile range (IQR), and the points extending from the box represent values that are 1.5 times greater than the IQR from the median value. R2 was calculated using a simple linear regression

  • Fig. 2 Distribution of dose and frequency by quartiles of half-life. A Dose (IU/kg) of octocog alfa; (B) dose of rurioctocog alfa pegol; (C) frequency (injections per week) of octocog alfa; and (D) frequency of rurioctocog alfa pegol. The box in the plot represents the interquartile range (IQR), and the points extending from the box represent values that are 1.5 times greater than the IQR from the median value. R2 was calculated using a simple linear regression


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