Background: This study aimed to investigate the safety and efficacy of steroid withdrawal therapy in kidney transplant recipients with tacrolimus, mycophenolate mofetil, everolimus based immunosuppression.
Methods: We analyzed 274 recipients who underwent kidney transplantation from August 2014 and July 2022. Among these recipients, 180 patients maintained an immunosuppressive regimen including steroids (steroid continuation [SC] group). The 94 patients were determined to withdraw steroid therapy (steroid withdrawal [SW] group). All patients in the SW group received tacrolimus-mycophenolate mofetil-everolimus based immunosuppression.
Results: The observation period was 4.96±2.11 years in the SC group and 4.38±2.03 years in the SW group. Five-year patient survival was 97.2% and 96.8%, and 5-year graft survival was 97.8% and 94.7% in SC and SW groups, respectively, with no significant difference. Estimated glomerular filtration rates were 43.6±18.3 mL/min/1.73 m² in the SC group and 42.0±15.3 mL/min/1.73 m² in the SW group. There was no significant difference in the 24-hour urinary protein excretion between two groups. The blood concentration of tacrolimus was 3.9±1.6 ng/dL and 3.6±1.5 ng/dL in the SC and SW groups, respectively. No significant difference was found in the incidence of borderline change, interstitial fibrosis and tubular atrophy, calcineurin inhibitor nephrotoxicity revealed by graft biopsy between two groups. However, the incidence of T cell-mediated rejection and transplant glomerulopathy were higher in the SW group (P=0.05 and P<0.01). The incidence of de novo donor-specific human leukocyte antigen (HLA) antibody (DSA) and non-DSA were similar in both groups. There was no significant difference in the incidence of cytomegalovirus or BK infection. The SW group had higher incidence of coronavirus disease 2019 than the SC group, but the difference was not significant (17.0% vs. 10.0%, P=0.12).
Conclusions: The early steroid withdrawal therapy using everolimus may lead to a higher incidence of transplant glomerulopathy. A longer follow-up is necessary to thoroughly assess this impact.