Efficacy and Safety of De Novo Everolimus Versus Mycophenolate Mofetil with Tacrolimus in Pediatric Kidney Transplantation: 1-year Follow-up

Introduction: The efficacy and safety of everolimus (EVE) in pediatric kidney transplantation is unknown. We aimed to evaluate and compare the efficacy and safety of EVE/tacrolimus (TAC) with mycophenolate mofetil (MMF)/TAC. Methods: This 12-month, nonrandomized single-center, open-labeled retrospective observational case-control trial included patients aged <18 years receiving kidney from a living-related or deceased donor between January 2012 and May 2017. Among 49 patients with TAC-based immunosuppression regimen, 13 received EVE/TAC regimen posttransplant, and the remaining 36 received the standard regimen using MMF/TAC. Clinical course was evaluated at 1 year. Results: Patient characteristics between both groups were not significantly different, except for recipient age (EVE/TAC vs MMF/TAC; median: 12.7 vs 5.8 years, p <0.01). Median estimated glomerular filtration rate was similar in both groups (EVE/TAC vs MMF/TAC; median: 72.3 vs 75.5 ml/min/m2) at 1 year. Incidence of Epstein-Barr virus infection was not significantly different in both, but incidence of cytomegalovirus viremia was significantly lower with EVE/TAC than with MMF/TAC (2 of 13 [15.4%] vs 19 of 36 [52.8%], p = 0.03). Stomatitis rate was higher in EVE/TAC than in MMF/TAC (23.0% vs 0.0%, p = 0.01). While neutropenia was not statistically different in both groups, no EVE/TAC regimen did show neutropenia. Acute rejection within 1 year did not differ in both groups. Pathological vascular injury was not significantly different in both groups, despite expected vascular protection by EVE. Conclusions: The efficacies of EVE/TAC and MMF/TAC in pediatric kidney transplantation for 1 year were comparable. Cytomegalovirus infection rate was significantly lower with EVE/TAC than with MMF/TAC regimen.