Population pharmacokinetics of mycophenolate mofetil in Thai lupus nephritis patients

Baralee Punyawudho1, Paungpaga Lertdumrongluk, Poorichaya Somparn

  • 1Department of Pharmacy Practice, Faculty of Pharmaceutical Sciences, Chulalongkorn University, Bangkok, Thailand.

Abstract

Insights

This study developed a pharmacokinetic model for mycophenolic acid (MPA) in Thai lupus nephritis patients. High interindividual variability in MPA exposure highlights the need for personalized dosing in this population.

Area of Science:

  • Pharmacology
  • Nephrology
  • Immunosuppression

Background:

  • Mycophenolic acid (MPA) is a first-line treatment for lupus nephritis.
  • Significant pharmacokinetic variability of MPA necessitates careful dosing.
  • Limited data exists on MPA pharmacokinetics in Asian lupus nephritis patients.

Purpose of the Study:

  • Develop a population pharmacokinetic model for MPA in Thai lupus nephritis patients.
  • Estimate MPA population pharmacokinetic parameters and their variability.
  • Provide a basis for individualized MPA dosing in this demographic.

Main Methods:

  • Analyzed 112 MPA plasma concentrations from 14 lupus nephritis patients.
  • Utilized NONMEM software for data analysis.
  • Validated the model using bootstrap and visual predictive checks.

Main Results:

  • A two-compartment model with lag time best described MPA pharmacokinetics.
  • Estimated mean apparent clearance (CL/F) was 14.5 l/h (45.2% variability).
  • Estimated mean central volume was 12.2 l (166% variability); no significant covariates identified.

Conclusions:

  • Successfully developed a population pharmacokinetic model for MPA in severe lupus nephritis.
  • Observed high interindividual variability in MPA pharmacokinetics supports personalized dosing.
  • The model can guide MPA dose adjustments in Thai and Asian lupus nephritis patients.

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