Session Time: 6:00pm-7:00pm
Presentation Time: 6:25pm-6:30pm
*Purpose: The ATHENA trial [NCT01843348] investigated safety and efficacy of everolimus combined with cyclosporine A [EVR/CsA] or tacrolimus [EVR/TAC] vs. tacrolimus plus mycophenolic acid [MPA/TAC] in de novo kidney transplant [KTx] recipients. The herein described post-hoc analysis evaluates the impact of the primary immunosuppressive regimen on the development of de novo donor specific antibodies [DSA] and non-HLA antibodies, as well as on the clinical outcome, within the first 12-months [M] after KTx.
*Methods: During this 12M randomized, open-label, prospective, controlled clinical trial, a total of 612 patients [pts] were enrolled in Germany and France. Pts were randomized at a 1:1:1 ratio to either EVR/CsA (C0: 3-8 ng/mL during M1-12 and C0: 75-125 ng/mL for M1-3; 50-100 ng/mL for M3-12, respectively), EVR/TAC (C0: 3-8 ng/mL during M1-12 and C0: 4-8 ng/mL for M1-2; 3-5 ng/mL for M3-12, respectively), or to the control arm MPA/TAC (C0: 1440-2000 mg/d during M1-12 and 4-8 ng/mL for M1-2; 3-5 ng/mL for M3-12); all with steroids. Here, we report initial results on the development of de novo DSA as part of a post-hoc analysis on the per-protocol population [PP] (N=337) within the first 12M after KTx.
*Results: The PP was comprised of n=80 pts in EVR/CsA, n=110 pts in EVR/TAC, and n=147 pts in MPA/TAC arm. Within the first 12M after KTx, only 7 pts in PP across all three treatment arms developed de novo DSA: n=4 in EVR/CsA, n=1 in EVR/TAC, n=2 in MPA/TAC arm. Further, only 2 of those 7 pts experienced a clinical event (BPAR) during the first 12M: n=1 in EVR/CsA and n=1 in MPA/TAC group; no graft loss or death was observed in this subset.
*Conclusions: In this post-hoc analysis of the as to date largest randomized European KTx study ATHENA, initial findings reveal that the primary immunosuppression selected does not seem to have a significant impact on the development of de novo DSA. Moreover, development of de novo DSA within first 12M does not appear to have a direct effect on the resulting clinical outcome. Further analyses on de novo DSA as well as on non-HLA antibody (ETA & AT1) development and outcomes are currently ongoing to evaluate these findings in more detail.
In memoriam Duska Dragun, our dear friend and always inspiring colleague, who passed away much too early.
To cite this abstract in AMA style:Arns W, Philippe A, Ditt V, Hauser IA, Thaiss F, Sommerer C, Suwelack B, Finkel A, Schiedel C, Dragun D, Nashan B. Athena – Effect of Primary Immunosuppression on Development of De Novo Donor Specific Antibodies within First Year After Kidney Transplantation [abstract]. Am J Transplant. 2021; 21 (suppl 3). https://atcmeetingabstracts.com/abstract/athena-effect-of-primary-immunosuppression-on-development-of-de-novo-donor-specific-antibodies-within-first-year-after-kidney-transplantation/. Accessed June 18, 2021.
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