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Related Experiment Videos

Experiences with leflunomide in solid organ transplantation.

James W Williams1, Deepak Mital, Anita Chong

  • 1University of Chicago Medical Center, and Rush Presbyterian-St. Luke's Medical Center, Chicago, Illinois, USA. jwilliam@surgery.bsd.uchicago.eclu.

Transplantation
|March 9, 2002
PubMed
Summary

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Leflunomide (Arava) shows promise in transplantation, with safe dosing up to 300 days. Monitoring serum levels is crucial due to variable drug half-life, allowing reduction of other immunosuppressants.

Area of Science:

  • Transplantation immunology
  • Pharmacology
  • Nephrology
  • Hepatology

Background:

  • Leflunomide (Arava), an established rheumatoid arthritis drug, demonstrates potential in experimental transplantation models.
  • Its efficacy in chronic rejection, synergy with calcineurin inhibitors, and antiviral properties support clinical investigation in transplant recipients.
  • This study reports on the use of leflunomide over three years in diverse clinical transplantation scenarios.

Purpose of the Study:

  • To evaluate the safety and efficacy of leflunomide (Arava) in liver and kidney transplant recipients.
  • To determine appropriate dosing strategies and therapeutic serum levels for leflunomide in transplant patients.
  • To assess the potential for reducing conventional immunosuppressive drugs when using leflunomide.

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Main Methods:

  • A retrospective review of 53 liver and kidney transplant recipients treated with leflunomide.
  • Pharmacokinetic (PK) study in renal transplant recipients to establish target serum levels and loading doses.
  • Correlation of drug toxicity with serum leflunomide levels and analysis of outcomes with reduced conventional immunosuppression.

Main Results:

  • Leflunomide was administered for up to 430 days; 37 patients received it for over 60 days.
  • Primary toxicities included anemia in renal recipients and elevated liver enzymes in liver recipients.
  • In patients with serum creatinine <3 mg/dL, leflunomide was well-tolerated at levels <80 microg/mL, allowing reduction of calcineurin inhibitors and prednisone without acute rejection.

Conclusions:

  • Leflunomide exhibits significant immunosuppressive activity in renal and liver transplant recipients, with safe administration for extended periods.
  • Concomitant immunosuppressants like calcineurin inhibitors and prednisone can be safely reduced when serum leflunomide levels exceed 50 microg/mL.
  • Monitoring serum leflunomide levels is essential due to a wide inter-patient variability in active metabolite half-life (>300%).