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Optimizing mycophenolic acid exposure for reduced relapse risk in paediatric nephrotic syndrome: An observational

Yiting Cai1,2, Baojing Liu1,2, Lizhi Chen3

  • 1Department of Pharmacy, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.

British Journal of Clinical Pharmacology
|October 9, 2025
PubMed
Abstract

Insights

Maintaining mycophenolic acid (MPA) AUC levels above 31.51 μg/h/mL is crucial for preventing relapse in pediatric nephrotic syndrome (NS). This finding supports individualized dosing for better patient outcomes.

Area of Science:

  • Pharmacology and Therapeutics
  • Nephrology
  • Pediatric Medicine

Background:

  • Mycophenolic acid (MPA) is effective in reducing relapses in pediatric nephrotic syndrome (NS).
  • However, significant pharmacokinetic variability necessitates optimized dosing strategies.
  • Understanding exposure-response relationships is key for effective maintenance therapy.

Purpose of the Study:

  • To establish risk reference values for MPA area under the concentration-time curve (AUC₀₋₁₂h) to prevent relapse in pediatric NS.
  • To identify a target AUC threshold for effective maintenance therapy.

Main Methods:

  • Retrospective cohort study of 89 pediatric NS patients on MPA.
  • Logistic regression and ROC curve analysis to determine optimal AUC cut-off.
  • Kaplan-Meier and Cox regression to assess relapse-free survival (RFS).

Main Results:

  • Lower MPA AUC₀₋₁₂h levels (<31.51 μg/h/mL) significantly correlated with relapse (P < 0.001).
  • MPA AUC₀₋₁₂h was confirmed as a protective factor (OR = 0.93).
  • An AUC₀₋₁₂h of 31.51 μg/h/mL was identified as the optimal risk reference value.

Conclusions:

  • Maintaining MPA AUC₀₋₁₂h ≥ 31.51 μg/h/mL significantly reduces relapse risk in pediatric NS.
  • Individualized mycophenolate mofetil (MMF) dosing guided by therapeutic drug monitoring is essential.
  • This approach optimizes treatment outcomes for pediatric NS patients.
Keywords:
mycophenolic acidnephrotic syndromepaediatricsrelapserisk reference value

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