Innovate with potential, and move forward with determination—individualized preventive treatment under the guidance of PK in the digital age

The development of science and technology has brought progress in the medical field
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Online and digital, these changes reflected in the new crown epidemic are not available in previous lives, and they are also one of the epitome of current medical progress
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Nowadays, digitalization is having an all-round impact on the diagnosis and treatment of many diseases including hemophilia
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Digital medical treatment-the "new weapon" for hemophilia treatment Digital medical treatment refers to a new modern medical method that applies modern computer technology and information technology to the entire medical process.
It is the development direction and management goal of public medical care1
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With the continuous development and progress of digital medical care, human health has been continuously improved.
The efficiency improvement, precise access and optimized payment brought about by digital medical care are accelerating the arrival of the "patient-centered" era.
The change in the health landscape has had a profound impact
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Digitalization has also brought tangible convenience to hemophilia patients
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During the epidemic, the application of telemedicine in patients with hemophilia demonstrated its convenience and accessibility, improved patient health and cost management, and at the same time avoided contact between patients and healthcare professionals (HCP), and reduced medical care.
Institutional burden 2
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In a broader sense, the widespread implementation of telemedicine will not only strengthen the direct care of bleeding patients, but also enable more people, especially those living in areas with insufficient medical services, to receive specialist hematology care3
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In terms of databases, the World Federation of Hemophilia (WFH) guidelines point out that the use of national online databases or World Bleeding Disease Registry Service (WBDR) data can better manage hemophilia patients in emergency and long-term, and use digital mobile The device allows patients to record their bleeding and transmit the information to the Hemophilia Clinic (HTC) 4 in real time
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PK software-the "right-hand man" for individualized treatment of hemophilia in the digital age.
As there are differences between individuals with hemophilia, it should be based on age, intravenous access, bleeding phenotype, pharmacokinetics (PK) characteristics, and clotting factors The supply of preparations, and the development of individualized preventive treatment plans adapted to the patient’s life>
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Among the many individualized preventive treatment plans, PK-guided individualized preventive treatment is the most effective plan for successful preventive treatment7
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In order to calculate PK parameters more conveniently and quickly, Takeda has developed a PK-guided hemophilia A management tool (recombinant human coagulation factor Ⅷ dose calculation software for injection, hereinafter referred to as "PK software")
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The software has been approved for marketing by the National Medical Products Administration (NMPA)
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PK software integrates the Bayesian algorithm with the aid of the population PK model and uses the two-compartment model.
It can be accurately calculated through limited blood samples and PK parameters, and can be visualized through individual PK characteristic curves and charts8
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Clinical Significance Application 9: Used by HCP to generate recommendations for the administration of rAHF-PFM based on the individual patient’s age and weight and other information as well as the local laboratory’s coagulation factor Ⅷ phase I coagulation activity measurement value of the patient’s sparse sample
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In addition, HCP can formulate individualized preventive treatment plans based on software prediction results, individual patient needs and treatment plans
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Applicable population: It is suitable for patients with hemophilia A who are 16 years old and above (weight 45 kg and above) receiving rAHF-PFM treatment
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Advantages and convenience-simplified PK detection process PK software can simplify the PK detection and data analysis process, compared with the previous recommended 10-11 sampling times10, with the aid of the PK software, it can pass at least 2 sampling times without a washout period, that is PK detection can be performed, and PK curve can be simulated10
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Feasibility-Helping the formulation of PK-guided individualized preventive treatment plans.
PK testing through PK software can better guide the formulation of individualized preventive treatment treatment plans
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A retrospective observational study, using PK software to perform PK detection on 6 patients with hemophilia, simulate the Bayesian curve, and develop individualized prevention and treatment plans
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The results show that PK-guided individualized treatment based on PK software can significantly reduce bleeding and improve the quality of life of patients 11
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Another study included 27 patients with severe hemophilia A who were treated with rAHF-PFM and used PK software for PK-guided individualized preventive treatment
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The results showed that the use of PK software increased the number of patients undergoing PK studies (patients had no PK data in the past), and provided a basis for the formulation of individualized preventive treatment plans7
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Summary Today, with the continuous enrichment, optimization, and iteration of hemophilia treatment methods, the approval and application of PK software demonstrates that the most urgent needs of patients are the starting point and the continuous exploration of treatment opportunities in new technical fields.
Work hard and believe that with the blessing of digitalization, the future will definitely bring more benefits to patients with hemophilia! References: 1.
Fan Yidong.
China Digital Medicine, 2008, 3(005):29-31.
2.
Valentino LA,et al.
Haemophilia.
2020 Sep;26(5)e230-e231.
3.
Kulkarni R,et al.
Haemophilia .
2018;24(1):33-42.
4.
Srivastava A .
et al.
Haemophilia.
2020;001–158.
5.
Thrombosis and Hemostasis Group of Hematology Branch of Chinese Medical Association, Chinese Hemophilia Collaborative Group.
Chinese Journal of Blood.
2020 ;41(4):265-271.
6.
Petrini P,et al.
Expert Rev Hematol 2015 Apr;8(2):237-46.
7.
Álvarez-Román MT,et al.
Haemophilia 2017 Jan;23(1):e50- e54.
8.
myPKFiT Instructions for Use 12/2020.
9.
https:// Lee M,et al.
2001.
The design and analysis of pharmacokinetic studies of coagulation factors.
ISTH Website, Scientific and Standardization Committee Communication p.
1–9.
11.
Pasca S,et al.
Thromb.
Res.
2017 Sep;157.
Approval number: VV-MEDMAT-54840 Approval time: 10/15/2021 Expiration time: 10/15/2023 Help medical and health professionals better understand the latest developments in the field of related diseases
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