Population pharmacokinetic analyses of methotrexate in pediatric patients: a systematic review.

Background and objectives: Methotrexate is widely utilized in the chemotherapy of malignant tumors and autoimmune diseases in the pediatric population, but dosing can be challenging. Several population pharmacokinetic models were developed to characterize factors influencing variability and improve...

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Published in:European Journal of Clinical Pharmacology Vol. 80; no. 7; pp. 965 - 983
Main Authors: Cheng, Yu, Zhang, Yujia, Zhang, Ying, Liu, Maobai, Zhao, Limei
Format: research systematic review tables/charts Journal Article
Published: Springer Nature Jul2024
Online Access:View this record in EBSCOhost
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      dt: Jul2024
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      pub: Springer Nature
      place: New York, New York
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        atl: Population pharmacokinetic analyses of methotrexate in pediatric patients: a systematic review.
      aug:
        au:
          Cheng, Yu
          Zhang, Yujia
          Zhang, Ying
          Liu, Maobai
          Zhao, Limei
        affil: https://ror.org/00v408z34 Department of Pharmacy, Shengjing Hospital Affiliated to China Medical University, 36 Sanhao Street, 110004, Shenyang, Liaoning Province, China
      sug:
        subj:
          Methotrexate Pharmacokinetics
          Pediatric Care
          Drug Monitoring
          Human
          Systematic Review
          Funding Source
          PubMed
          Embase
          Checklists
          Models, Structural
          Body Size
          Kidney Physiology
          Drug Elimination Routes
          Polymorphism, Genetic
          Male
          Female
          Child
          Adolescence
          Descriptive Statistics
          Dose-Response Relationship, Drug
          Child: 6-12 years
          Adolescent: 13-18 years
          Male
          Female
      ab: Background and objectives: Methotrexate is widely utilized in the chemotherapy of malignant tumors and autoimmune diseases in the pediatric population, but dosing can be challenging. Several population pharmacokinetic models were developed to characterize factors influencing variability and improve individualization of dosing regimens. However, significant covariates included varied across studies. The primary objective of this review was to summarize and discuss population pharmacokinetic models of methotrexate and covariates that influence pharmacokinetic variability in pediatric patients. Methods: Systematic searches were conducted in the PubMed and EMBASE databases from inception to 7 July 2023. Reporting Quality was evaluated based on a checklist with 31 items. The characteristics of studies and information for model construction and validation were extracted, summarized, and discussed. Results: Eighteen studies (four prospective studies and fourteen retrospective studies with sample sizes of 14 to 772 patients and 2.7 to 93.1 samples per patient) were included in this study. Two-compartment models were the commonly used structural models for methotrexate, and the clearance range of methotrexate ranged from 2.32 to 19.03 L/h (median: 6.86 L/h). Body size and renal function were found to significantly affect the clearance of methotrexate for pediatric patients. There were limited reports on the role of other covariates, such as gene polymorphisms and co-medications, in the pharmacokinetic parameters of methotrexate pediatric patients. Internal and external evaluations were used to assess the performance of the population pharmacokinetic models. Conclusion: A more rigorous external evaluation needs to be performed before routine clinical use to select the appropriate PopPK model. Further research is necessary to incorporate larger cohorts or pool analyses in specific susceptible pediatric populations to improve the understanding of predicted exposure profiles and covariate identification.
      pubtype: Academic Journal
      doctype:
        research
        systematic review
        tables/charts
        Journal Article
      ougenre: Article
    language: English
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