Study designs
¹A post-hoc analysis using the Australian and New Zealand Dialysis and Transplant Registry (ANZDATA) to assess the seven-year risk of incident cancer and other graft outcomes among a subgroup of recipients who had participated in the A2309 study (N=95). Of 95 recipients, 66 were randomized to everolimus (1.5 mg or 3 mg) with reduced cyclosporine and 29 received mycophenolate sodium and standard exposure cyclosporine.
²A 24‐month, prospective, open‐label trial in 2037 de novo renal trans‐plant recipients randomized (1:1) within 24 hours of transplantation to receive everolimus with reduced‐exposure calcineurin inhibitor (n=1022) or mycophenolate with standard‐exposure (n=1015) to assess efficacy, renal function, and safety outcomes of the two regimens.
³A prospective, multicenter, open-label study, wherein de novo liver transplant patients (N=719) were randomized at day 30±5 to (i) everolimus initiation with tacrolimus elimination (n=231) (ii) everolimus initiation with reduced-exposure tacrolimus (n=245) or (iii) standard-exposure tacrolimus (n=243) to evaluate the efficacy and safety of using everolimus to eliminate or reduce tacrolimus compared to a standard tacrolimus regimen.
⁴A prospective, multicenter, open-label study, wherein de novo liver transplant patients (N=719) were randomized at day 30 to (i) everolimus + reduced exposure tacrolimus (n=245), (ii) everolimus + tacrolimus elimination (n=231), or (iii) standard exposure tacrolimus (n=243) to evaluate the efficacy and safety of the regimen at 3 years after transplantation.
⁵A multicenter, open-label, study, wherein 284 living-donor liver transplant patients were randomized at 30±5 days posttransplant to start everolimus+reduced tacrolimus (n=142) or continue standard tacrolimus (n=142) to compare the efficacy and safety of the two regimen at 12 months after transplantation. 6A pooled analysis of data from 2 randomized liver transplant trials (N=772) to further evaluate the efficacy and safety of everolimus with reduced tacrolimus (n=387) versus standard tacrolimus (n=385) regimen at month 24

Abbreviations:
IS, immunosuppressant; LT, liver transplant; CNI, Calcineurin inhibitors; tBPAR, treated biopsy-proven acute rejection; eGFR, estimated glomerular filtration rate; rCNI, reduced-exposure calcineurin inhibitor; HCC, hepatocellular carcinoma; CMV, cytomegalovirus; BKV, BK virus.

References:
1. Lim WH, et al. Kidney Int. 2017;91(4):954-963. 2. Berger SP, et al. Am J Transplant. 2019;19(11):3018-3034. 3. De Simone P, et al. Am J Transplant. 2012;12(11):3008-3020. 4. Fischer L, et al. Transplantation. 2015;99(7):1455-1462. 5. Jeng L B, et al. Am J Transplant. 2018;18(6):1435-1446. 6. Lee et al. Transplantation. 2021;105(7):1564-1575.