Everolimus is associated with long-term benefits, such as preserving renal function and reducing the incidence of infections, malignancies and major cardiovascular events (MACE). The Certic registry was designed to assess the impact of everolimus treatment on patient outcome for at least 5 years in heart or kidney transplant recipients from 34 Italian centers.

Certic is an observational, multicentre, prospective study that included patients on everolimus treatment for at least 6 months. All patients were evaluated at enrolment and every year for 5 years (T5). Out of 781 patients globally enrolled, 380 were kidney recipients. Here we report results from this patients' cohort, of which 88.4% started everolimus within 3 months after transplant and remained on treatment 2 years on average before entering the study (de novo group), and 11.6% started everolimus on average 1.6 years after transplant and remained on treatment 1.3 years before entering the study (maintenance group). Mean total follow-up time was 7.1 and 7.9 years respectively.

These were results at T5 in de novo and maintenance group respectively: patient survival 94.6% and 86.4%, graft survival 95.8% and 93.2%, 6.8% and 9.1% of patients are back on dialysis at a mean of 5.3 and 3.0 years from transplant. Overall, the average reduction in kidney function (eGFR, mL/min/1.73m²) was approximately 1 mL/year maintaining mean levels of 50.8 mL/min at T5 and proteinuria mean values increased from T0 to T5 was of 0.18±1.56 g/24h, reaching mean levels of 0.57±1.0 g/24h at T5. The overall incidence rate of post-transplant neoplasia was 2.2%, mainly non-melanoma skin cancers, and 8.7% of patients had at least one MACE, mainly acute myocardial infarction and heart failure. CMV infection was detected in 4.8% of de novo and in 15.9% of maintenance patients.

The 5-year prospective observation of this selected cohort of kidney transplant recipients indicates that use of everolimus is associated with high graft and patient survival rates, preservation of renal function, low rate of CMV infections in de novo group, and low incidence of malignancies and MACE.

CITATION INFORMATION: Furian L, Di Maria L, Cappelli G, Carmellini M, Spagnoletti G, Piredda G, Todeschini P, Chiaramonte S, Tisone G. Long Term Outcome of Kidney Transplant Recipients Treated with Everolimus: Final 5-Years Results from the Certic Observational Study. Am J Transplant. 2016;16 (suppl 3).

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