Low Mycophenolic Acid Plasma Concentrations Increase Risk of Acute Rejection After Renal Transplantation in High-Risk Patients: Presented at TTS

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Title: Low Mycophenolic Acid Plasma Concentrations Increase Risk of Acute Rejection After Renal Transplantation in High-Risk Patients: Presented at TTS
URL: http://www.pslgroup.com/dg/2280FA.htm
Doctor's Guide
August 11, 2008

By Rachel Parratt

SYDNEY, Australia -- August 11, 2008 -- Post hoc exploratory analysis from the Fixed Dose Concentration Controlled (FDCC) study showed a significant difference in the incidence of rejection between high-risk and low-risk renal transplant patients with mycophenolic acid (MPA) plasma concentrations above and below 30 mg/h/L.

Principal investigator Teunis Van Gelder, MD, Department of Nephrology, Erasmus University Medical Center, Rotterdam, Netherlands, presented the results here on August 11 at the 22nd International Congress of the Transplantation Society (TTS 2008).

This post hoc analysis was carried out to determine the relationship between MPA plasma concentrations and the incidence of acute rejection in high-risk versus low-risk renal transplant patients.

Patients were defined as high-risk if they had 1 or more of the following characteristics: delayed graft function, second or third transplantation, panel reactive antibodies greater than 15%, or 4 or more human leukocyte antigen (HLA)-mismatches. All other patients were considered low-risk.

In the full study population (N = 901), an MPA concentration <30 mg/h/L on day 3 after transplantation was associated with a risk of developing acute rejection in the first month.

Post hoc, 491 patients (54%) were classified as high-risk, and rejection incidence was 14.6% for MPA levels <30 mg/h/L and 7.9% for levels >30 mg/h/L. Patients were treated with either corticosteroids and/or cyclosporine (n = 254) or tacrolimus (n = 237).

There was a greater difference in the incidence of acute rejection in the first month among high-risk patients treated with tacrolimus with an MPA concentration (Area Under the Curve [AUC] 0-12) <30 mg/h/L (24.2%) versus >30 mg/h/L (10.5% [P = .012])

The difference in rejection incidence in high-risk patients was comparable to the whole study population. In low-risk patients, rejection rates with MPA concentration >30 and <30 mg/h/L were similar (5.5% vs 4.4%).

"This supports the recommendation to perform therapeutic drug monitoring for mycophenolate mofetil in selected patient populations," said Dr. Van Gelder.

Funding for this study was provided by Roche.

[Presentation title: Mycophenolic Acid Plasma Concentrations and Acute Rejection Rate in High-Risk Versus Low-Risk Renal Transplant Patients Receiving Mycophenolate Mofetil. Abstract 109]

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