Evaluation of acute graft rejection rates 1-year post renal transplantation: results of a formulary change to a steroid-sparing thymoglobulin regimen in an academic medical center

Title: Evaluation of acute graft rejection rates 1-year post renal transplantation: results of a formulary change to a steroid-sparing thymoglobulin regimen in an academic medical center Authors: Andrea N. Sikora1, Pharm.D. student, Robert C. Newsome1, Pharm.D. student; Todd Merchen2, MD; Donna J. Vasil3, Pharm.D.; Dianne May1,2 Pharm.D., BCPS; University of Georgia College of Pharmacy1; Medical College of Georgia; Georgia Health Sciences Health System3

Purpose: This study evaluated the incidence of acute graft rejection at 1-year post-transplantation in first-time renal transplant recipients with panel reactive antibody (PRA) level < 20% who received an induction regimen of interleukin-2 (IL-2) antagonist (basiliximab or daclizumab) plus corticosteroids versus a steroid-sparing thymoglobulin induction regimen. The incidence of complications in those on steroid-sparing thymoglobulin regimen was also compared with those on an interleukin-2 antagonist plus steroid regimen.

Methods: A retrospective chart review was conducted on all Georgia Health Sciences Health System patients who met criteria from May 2009 Ð May 2011. These data were compared to a previous evaluation from May 2005 Ð May 2007, when IL-2 antagonists plus steroids was the preferred formulary induction regimen for low-risk renal transplant patients. In addition to 1-year post transplant rejection rates, evaluated events included the incidence of new onset diabetes, cardiovascular adverse events, infection rates and type, percentage of patients remaining steroid-free, steroid-resistance acute graft rejection, malignancy, lymphoproliferative disorder, and delayed graft function. This study was reviewed and approved by the HAC at Georgia Health Sciences Health System.

Results: A total of 150 renal transplant patients were evaluated. Data analysis of 1-year post-transplant rejection rates in the steroid-sparing thymoglobulin group and in the IL-2 plus steroid group is currently underway. Data analysis should be completed by late August.

Conclusions: Conclusions are pending.