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The Impact of Tacrolimus Trough Variability on Acute Rejection Following Lung Transplantation

K. Evans1, K. Beermann1, H. Lee2, M. Harris1, C. W. Frankel3, H. Berry1, H. Ali3

1Pharmacy, Duke Health, Durham, NC, 2Biostatistics and Bioinformatics, Duke University, Durham, NC, 3Pulmonary, Allergy, and Critical Care, Duke Health, Durham, NC

Meeting: 2022 American Transplant Congress

Abstract number: 530

Keywords: FK506, Lung transplantation, Pharmacokinetics, Rejection

Topic: Clinical Science » Pharmacy » 29 - Non-Organ Specific: Pharmacokinetics / Pharmacogenomics / Drug interactions

Session Information

Session Name: Non-Organ Specific: Pharmacokinetics / Pharmacogenomics / Drug interactions

Session Type: Rapid Fire Oral Abstract

Date: Tuesday, June 7, 2022

Session Time: 5:30pm-7:00pm

 Presentation Time: 6:10pm-6:20pm

Location: Hynes Room 311

*Purpose: This study aimed to evaluate the association of tacrolimus coefficient of variation (CV) with biopsy-proven acute cellular rejection in the first year following lung transplant (LT).

*Methods: This was a retrospective chart review of 229 adult LT recipients who received basiliximab induction and tacrolimus-based triple drug maintenance immunosuppression. Tacrolimus CV at 0-3, 3-6, and 6-12 months was compared to the median CV of the cohort to assign patients to a high or low variability group. Total acute rejection score (TRS) at 12-months was compared between these groups by two-sample t-tests. The TRS was calculated as the summed scores of all biopsy specimens with points allocated as follows: A0=0, A1=1, A2=2, A3=3, A4=4, and isolated B grade=1. The development of chronic lung allograft dysfunction (CLAD) and antibody-mediated rejection (AMR) were analyzed as secondary outcomes.

*Results: An average (SD) of 50 (16.9) levels per patient were collected between 0-12 months post-transplant. The mean (SD) of the average tacrolimus levels for each patient were 9.9 ng/mL (1.4 ng/mL), 10.5 ng/mL (2.4 ng/mL), and 10.5 ng/mL (1.8 ng/mL) between 0-3, 3-6, and 6-12 months, respectively. The median CV of tacrolimus levels was 40%, 30%, and 30% between 0-3, 3-6, and 6-12 months, respectively. The mean (SD) TRS was 1.6 (1.7). Patients with high tacrolimus variability at 0-3, 3-6, and 6-12 months on average scored 0.18 (mean 1.6 vs. 1.5; 95% confidence interval [CI]: -0.3 to 0.66, p=0.46), 0.14 (mean 1.7 vs. 1.5; 95% CI: -0.32 to 0.6, p=0.55), and 0.12 (mean 1.6 vs. 1.5; 95% CI: -0.34 to 0.58, p=0.62) point higher in twelve-month TRS, respectively. The incidences of CLAD and AMR were numerically greater in the high variability group throughout certain periods.

*Conclusions: High tacrolimus CV was not associated with twelve-month total acute rejection score. Further studies are needed to assess long-term outcomes with tacrolimus level variability.

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To cite this abstract in AMA style:

Evans K, Beermann K, Lee H, Harris M, Frankel CW, Berry H, Ali H. The Impact of Tacrolimus Trough Variability on Acute Rejection Following Lung Transplantation [abstract]. Am J Transplant. 2022; 22 (suppl 3). https://atcmeetingabstracts.com/abstract/the-impact-of-tacrolimus-trough-variability-on-acute-rejection-following-lung-transplantation/. Accessed May 28, 2025.

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