INTRODUCTION AND AIMS: kidney transplant recipients benefit from the use of mTOR inhibitors thanks to their anti-neoplastic effects that may reduce the incidence of post-transplant neoplasia. However, in some clinical trials their use has been associated with a higher incidence of rejection compared to mycophenolate.
METHODS: kidney transplant recipients transplanted from June 2013 to May 2016 in our hospital were included in this study (n=413). All patients received tacrolimus with prednisone in combination with either mycophenolate or an mTOR inhibitor (either sirolimus or everolimus). Patients who underwent combined transplantation (n=51), early transplantectomy (n=5), lost at the follow-up (n=7) and with a different basal immunosuppression (n=3) were discarded from the final analysis (final n= 347). Baseline characteristics of the patients were retrospectively collected as well as 1-year outcomes. Target through levels were 6-10 ng/ml for tacrolimus and 3-6 ng/ml for mTOR inhibitor, respectively.
RESULTS: in the intention-to-treat analysis (Table 1), patients receiving mycophenolate were younger (52.52 ± 13.24 vs 58.68 ± 12.26, p<0.01) and more likely to have received a graft from a living donor (57.9% vs 24.3%, p<0.01) compared to the mTORi group. In spite of that, there were no differences in 1-year outcomes between groups, including incidence of cellular and/or humoral rejection, graft loss and death. There was no difference for 1-year renal function between groups (creatinine 1.39 ± 0.54 vs 1.45 ± 0.55 mg/dl mycophenolate vs mTORi respectively, p=0.25). Results did not change in the per-protocol analysis and when living and cadaveric donors were analyzed separately (data not shown).
CONCLUSIONS: in a real-life setting, a protocol based on a mTOR inhibitor (either sirolimus or everolimus) with tacrolimus and prednisone could be employed as a standard immunosuppressive regimen and was associated with the same incidence of rejection, graft loss and 1-year renal function compared to a classical mycophenolate regimen.
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