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.
About The Expert
Klaus Nunes Ficher
Yasmin Dreige
Paulo Ricardo Gessolo Lins
Alexandra Nicolau Ferreira
Juliana Toniato de Rezende Freschi
Kamilla Linhares
Suelen Stopa Martins
Luciana Custodio
Marina Cristelli
Laila Viana
Daniel Wagner Santos
Renato de Marco
Maria Gerbase-DeLima
Henrique Proença
Wilson Aguiar
Monica Nakamura
Claudia Rosso Felipe
Jose Medina Pestana
Helio Tedesco Silva Junior
References
PubMed