Long-term Efficacy and Safety of Everolimus Versus Mycophenolate in Kidney Transplant Recipients Receiving Tacrolimus

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 are lacking. This is a 5-y follow-up post...

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Bibliographic Details
Published in:	Transplantation Vol. 106; no. 2; pp. 381 - 390
Main Authors:	Nunes Ficher, Klaus, Dreige, Yasmin, Gessolo Lins, Paulo Ricardo, Nicolau Ferreira, Alexandra, Toniato de Rezende Freschi, Juliana, Linhares, Kamilla, Stopa Martins, Suelen, Custodio, Luciana, Cristelli, Marina, Viana, Laila, Wagner Santos, Daniel, de Marco, Renato, Gerbase-DeLima, Maria, Proença, Henrique, Aguiar, Wilson, Nakamura, Monica, Rosso Felipe, Claudia, Medina Pestana, Jose, Tedesco Silva, Helio
Format:	Journal Article
Language:	English
Published:	United States Lippincott Williams & Wilkins 01-02-2022
Subjects:	Drug Therapy, Combination Everolimus - adverse effects Graft Rejection Graft Survival Humans Immunosuppressive Agents - adverse effects Kidney Transplantation - adverse effects Mycophenolic Acid - adverse effects Prospective Studies Tacrolimus - adverse effects
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Summary:	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 are lacking. This is a 5-y 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 (EVR), and prednisone (rabbit antithymocyte globulin/EVR, n = 85); basiliximab, tacrolimus, everolimus, and prednisone (basiliximab/EVR, n = 102); or basiliximab, tacrolimus, mycophenolate, and prednisone (basiliximab/mycophenolate, n = 101). There were no differences in the incidence of treatment failure (31.8% versus 40.2% versus 34.7%, P = 0.468), de novo donor-specific HLA antibodies (6.5% versus 11.7% versus 4.0%, P = 0.185), patient (92.9% versus 94.1% versus 92.1%, P = 0.854), and death-censored graft (87.1% versus 90.2% versus 85.1%, P = 0.498) survivals. Using a sensitive analysis, the trajectories of estimated glomerular filtration rate 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% versus 30.4% versus 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 3 mg/kg rabbit antithymocyte globulin dose followed by EVR combined with reduced tacrolimus concentrations was associated with similar efficacy and renal function compared with the standard of care immunosuppressive regimen.
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ISSN:	0041-1337 1534-6080
DOI:	10.1097/TP.0000000000003714