This is a 1 year interim analysis of the results of a 3 year, single center, randomized, prospective, open-label study comparing the efficacy and tolerability of everolimus (Ev) versus rapamune (Ra) in a steroid free, micro-emulsion cyclosporine based maintenance immunosuppression regimen with ATG induction. Living and deceased donor kidney recipients were randomized 2:1 based on donor type and primary versus re-transplant to receive either Ev or Ra. The 60 enrolled patients were transplanted from 3/14 through 5/15 (19 Ra, 41 Ev). There was no significant difference in demographics between the Ra and Ev groups. Efficacy Results: There were 2 deaths due to MI (R) and sepsis (E)(p=ns). There were 3 graft losses, 1 due to early thrombosis, 1 to chronic rejection, and 1 to recurrent ACR/AMR episodes; all in the Ev arm (p=ns). There were 5/41 (12%; 2 AMR, 2 mixed ACR/AMR, 1 ACR) Ev and 1/19 (5%, ACR) Ra recipients that had rejection in the first year. Post-transplant DSA was detected in 8/41 (19.5%) of EV and 1/19 (5%) of Ra recipients (p=0.25). Tolerability Results: There was no significant difference in incidence of joint pain, oral ulcers, severe hypertriglyceridemia, lymphocele, wound infection, CMV disease, or incisional hernia. In 4/19 (21%) of Ra and 11/41 (27%) of Ev recipients the mTOR inhibitor was discontinued within the first year (2/4 for side effects in the Ra group and 8/11 in the Ev group) (p=ns). There were 3 episodes of urinary-related sepsis in the Ra group and none in the Ev group (p=0.03). The mean Hb, and triglycerides were not significantly different at all time points in the first year. The mean WBC count was consistently lower in the Ev group for the first 7 months post-transplant but this was not statistically significant. Conclusion: Rapamune and everolimus had comparable efficacy and tolerability profiles in this study.

CITATION INFORMATION: Pelletier R., Rajab A., Henry M., Bumgardner G. Comparison of De Novo Rapamune versus Everolimus Maintenance Immunosuppression; an Interim Analysis Am J Transplant. 2017;17 (suppl 3).

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