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<p>Tacrolimus is the most commonly used immunosuppression drug after solid organ transplantation; however, its dosing is challenging due to substantial inter-individual variability, often resulting in blood levels that deviate from the target therapeutic range. We explored whether a dynamically customized, phenotypic-outcome-guided drug dosing method could improve maintenance of drug trough levels within pre-determined target ranges, focusing on tacrolimus immediately after liver transplantation. This single-center, partially blinded, completed clinical trial involved 62 adults undergoing liver transplantation, block randomized into parallel groups: standard-of-care (SOC) clinician-determined or Phenotypic Personalized Medicine (PPM)-guided tacrolimus dosing. The primary outcome was percentage of post-transplant days with large (&gt;2 ng/mL) deviations from the target range. At trial completion, analysis found statistically significant improvement in the PPM group (<i>n</i> = 27): 24.2% of days showing large deviations compared to 38.4% in the SOC group (<i>n</i> = 29) (difference −14.2%, 95% CI: −26.7 to −1.5 %, <i>P</i> = 0.029) with no increase in adverse events. These results demonstrate that PPM-guided tacrolimus dosing more effectively maintains drug levels within the target range compared to SOC, suggesting a promising approach to improving drug dosing. The trial was registered at ClinicalTrials.gov with the identifier NCT03527238.</p>

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Tacrolimus dosing in liver transplant recipients using phenotypic personalized medicine: A phase 2 randomized clinical trial

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年5月16日

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  • Jeffrey Khong,
  • Megan Lee,
  • Curtis Warren,
  • Un Bi Kim,
  • Sergio Duarte,
  • Kenneth A. Andreoni,
  • Sunaina Shrestha,
  • Mark W. Johnson,
  • Narendra R. Battula,
  • Danielle M. McKimmy,
  • Thiago Beduschi,
  • Ji-Hyun Lee,
  • Derek M. Li,
  • Chih-Ming Ho,
  • Ali Zarrinpar

摘要

Tacrolimus is the most commonly used immunosuppression drug after solid organ transplantation; however, its dosing is challenging due to substantial inter-individual variability, often resulting in blood levels that deviate from the target therapeutic range. We explored whether a dynamically customized, phenotypic-outcome-guided drug dosing method could improve maintenance of drug trough levels within pre-determined target ranges, focusing on tacrolimus immediately after liver transplantation. This single-center, partially blinded, completed clinical trial involved 62 adults undergoing liver transplantation, block randomized into parallel groups: standard-of-care (SOC) clinician-determined or Phenotypic Personalized Medicine (PPM)-guided tacrolimus dosing. The primary outcome was percentage of post-transplant days with large (>2 ng/mL) deviations from the target range. At trial completion, analysis found statistically significant improvement in the PPM group (n = 27): 24.2% of days showing large deviations compared to 38.4% in the SOC group (n = 29) (difference −14.2%, 95% CI: −26.7 to −1.5 %, P = 0.029) with no increase in adverse events. These results demonstrate that PPM-guided tacrolimus dosing more effectively maintains drug levels within the target range compared to SOC, suggesting a promising approach to improving drug dosing. The trial was registered at ClinicalTrials.gov with the identifier NCT03527238.