The short-term efficacy and safety of everolimus in combination with tacrolimus have been described in several clinical trials. Yet, detailed long-term data comparing the use of everolimus or mycophenolate in kidney transplant recipients receiving tacrolimus is lacking.
This is a 5-year follow-up post hoc analysis of a prospective trial including 288 patients who were randomized to receive a single 3 mg/kg dose of rabbit antithymocyte globulin, tacrolimus, everolimus, and prednisone (r-ATG/EVR, n=85); basiliximab, tacrolimus, everolimus, and prednisone (BAS/EVR, n=102); or basiliximab, tacrolimus, mycophenolate, and prednisone (BAS/MPS, n=101).
There were no differences in the incidence of treatment failure (31.8% vs. 40.2% vs. 34.7%, p=0.468), de novo donor-specific HLA antibodies (6.5 vs. 11.7 vs. 4.0%, p=0.185), patient (92.9% vs. 94.1% vs. 92.1%, p = 0.854) and death-censored graft (87.1% vs. 90.2% vs. 85.1%, p = 0.498) survivals. Using a sensitive analysis, the trajectories of eGFR were comparable in the intention-to-treat (p=0.145) and per protocol (p=0.354) populations. There were no differences in study drug discontinuation rate (22.4% vs. 30.4% vs. 17.8%, p=0.103).
In summary, this analysis in a cohort of de novo low/moderate immunologic risk kidney transplant recipients suggests that the use of a single 3mg/kg r-ATG dose followed by EVR combined with reduced TAC concentrations was associated with similar efficacy and renal function compared to the standard of care immunosuppressive regimen.Supplemental Visual Abstract; http://links.lww.com/TP/C160.

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