Background: Candidacy for kidney transplantation is being progressively liberalized, and the safety and efficacy of early withdrawal of corticosteroids in high-risk patients have not been fully characterized.
Methods: We analyzed the safety and efficacy of an early corticosteroid withdrawal regimen of rabbit antithymocyte globulin induction, tacrolimus, mycophenolate mofetil, and steroid withdrawal by day 5 after transplantation in our study cohort of 634 kidney transplant recipients that included 27% African American and 18% Hispanic recipients. Fifty-five percent of the recipients were recipients of deceased-donor kidneys, and 46% of deceased-donor kidneys were kidneys from expanded criteria donors.
Results: Kaplan-Meier patient survival at 1, 3, and 5 years after transplantation was 98.6%, 94.6%, and 90.2%, and death-censored graft survival was 96.2%, 91.9%, and 87.6%, respectively. During a mean follow-up of 57 months, 89.3% of patients remained off of corticosteroids, and the incidence of acute rejection including subclinical rejection identified by protocol biopsy was 12.0%. Multivariable analysis identified age older than 60 years as protective against (P=0.01) and the African American ethnicity as a risk factor for (P=0.03) rejection. Delayed graft function (P<0.0001), rejection (P<0.0001), and transplant panel reactive antibody 20% or more (P=0.03) were risk factors for graft loss. Opportunistic infections included viral in 15.3%, fungal in 1.6%, and parasitic in 0.6% of the patients. Posttransplantation malignancy occurred in 9.1% of patients.
Conclusions: An early corticosteroid withdrawal regimen of rabbit antithymocyte globulin induction, tacrolimus, and mycophenolate mofetil is associated with excellent patient and kidney graft survival in an ethnically diverse population with risk factors for poor outcomes.