The ATHENA study was set up to compare efficacy and safety of everolimus [EVR] combined with tacrolimus [TAC] or cyclosporine A [CyA] vs. a mycophenolic acid [MPA] plus TAC standard regimen in de novo kidney transplant [KTx] recipients.

Methods: In this 12 months [M] prospective, open-label, multi-center study, 612 patients [pts] were randomized 1:1:1 at time of Tx to either EVR (3-8ng/ml M1-M12) +TAC (4-8ng/ml M1-M3; 3-5ng/ml M3-M12), or EVR (3-8ng/ml M1-M12) +CyA (75-125ng/ml M1-M3; 50-100ng/ml M3-M12) or TAC (4-8ng/ml M1-M3; 3-5ng/ml M3-M12) +MPA; all with steroids. Here we report M12 efficacy and safety data from 208 EVR+TAC, 199 EVR+CyA and 205 TAC+MPA treated pts.

Results: Treated BPAR occurred in 6.7% of EVR+TAC vs 17.6% of EVR+CyA and 3.9% of TAC+MPA pts. Most events were graded mild (BANFF IA: 1.9% vs 9% vs 1.5%), only few as BANFF IIB/III (1.5% vs 2% vs 0.5%, respectively). Death occurred in 5 EVR+TAC pts, 5 EVR+CyA and 6 TAC+MPA pts. Incidence of graft loss was: 4.8% (10 pts) in EVR+TAC vs 6.5% (13pts) in EVR+CyA and 2.9% (6pts) in TAC+MPA group, including 5 primary non-functioning grafts in each EVR-group and 1 in TAC+MPA group. Safety was comparable with incidence of AEs leading to study drug discontinuation or dose adjustment/interruption [d/p] in 56.7% pts of EVR+TAC, 55.5% pts of EVR+CyA vs 61.3% pts in TAC+MPA arm. Main reasons for d/p of study drug were infections (as reason for d/p: 15.2%EVR+TAC, 10.1%EVR+CyA, 31.3%TAC+MPA) and leukopenia (as reason for d/p: 1.9%EVR+TAC, 3.0%EVR+CyA vs.10.8%TAC+MPA). There were no differences on wound healing/complications with corresponding total incidences of 41.9% in EVR+TAC, 38.9% in EVR+CyA and 43.2% in TAC+MPA group. There was no difference in proteinuria and incidence of nephrotic proteinuria was 1.3% in EVR+TAC vs 0.7% in EVR+CyA and 3.7% in TAC+MPA treated patients.

Conclusion: ATHENA as to date largest randomized European KTx study confirmed good efficacy and event rates within international standards for all 3 groups. There were no unexpected safety events for this patient population. Of note, there were no differences in reported wound healing, no differences in proteinuria but less leukopenia and fewer infections with EVR-based regimens.

CITATION INFORMATION: Suwelack B., Sommerer C., Dragun D., Witzke O., Hugo C., Kamar N., Merville P., Hauser A., Schenker P., Junge M., Nashan B., Thaiss F. The ATHENA Study: 12 Months Safety and Efficacy Data from Everolimus Combined with Tacrolimus or Cyclosporine Compared to a Standard Tacrolimus-Mycophenolate Regimen in De Novo Kidney Transplant Patients Am J Transplant. 2017;17 (suppl 3).

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