Date: Tuesday, June 14, 2016
Session Name: Poster Session D: Kidney Immunosuppression: Novel Agents
Session Time: 6:00pm-7:00pm
Presentation Time: 6:00pm-7:00pm
Location: Halls C&D
Studies consistently show worse outcomes for black vs non-black kidney transplant recipients. At 7 yrs post-transplant in BENEFIT-EXT (NCT00114777), bela was associated with similar graft survival and improved renal function vs CsA. We examined outcomes by race in BENEFIT-EXT.
Recipients of extended criteria donor kidneys were randomized to bela more intense (MI), bela less intense (LI), or CsA immunosuppression. All randomized, transplanted pts were analyzed through 7 yrs. Time to death or graft loss was compared between regimens with Cox regression. Race and treatment effect were assessed. The interaction of treatment and race was also considered. GFR was estimated from months 1–84 using a repeated measures model.
Of 543 randomized pts, 71 were black and 472 were non-black. See figure for hazard ratios for the time to death or graft loss. Serious AE rates in black vs non-black pts were similar across regimens. In black and non-black pts, estimated mean GFR increased over 7 yrs for both bela regimens but declined for CsA. In black pts, GFR slopes diverged over time between bela MI and CsA (P=.024), but not bela LI and CsA (P=.10). In non-black pts, GFR slopes diverged between bela and CsA over time; the interaction of the treatment vs time effect deriving from the model favored each bela regimen vs CsA (P≤.0012).
In this post-hoc analysis, bela-treated black and non-black pts exhibited similar outcomes. Although estimated mean GFR was higher in black pts treated with bela vs CsA, interpretation is limited by the small number of black pts.
|Bela MI||Bela LI||CsA||Bela MI||Bela LI||CsA|
|Pts evaluable for death or graft loss at month 84, n/N||14/25||16/24||15/22||114/159||122/151||93/162|
|Acute rejection by month 84, n/N||5/25||4/24||6/22||30/159||30/151||23/162|
|Serious AE, %||80||83||91||88||90||83|
|Estimated mean GFR at month 84, mL/min/1.73 m2||65.1||55.9||31.0||52.0||53.8||36.3|
CITATION INFORMATION: Florman S, Durrbach A, Duro Garcia V, Calderon K, Meier-Kriesche U, Polinsky M, Zhao H, Medina Pestana J. Outcomes in Black vs Non-Black Patients Administered Belatacept (Bela) or Cyclosporine (CsA) in BENEFIT-EXT. Am J Transplant. 2016;16 (suppl 3).
To cite this abstract in AMA style:Florman S, Durrbach A, Garcia VDuro, Calderon K, Meier-Kriesche U, Polinsky M, Zhao H, Pestana JMedina. Outcomes in Black vs Non-Black Patients Administered Belatacept (Bela) or Cyclosporine (CsA) in BENEFIT-EXT. [abstract]. Am J Transplant. 2016; 16 (suppl 3). https://atcmeetingabstracts.com/abstract/outcomes-in-black-vs-non-black-patients-administered-belatacept-bela-or-cyclosporine-csa-in-benefit-ext/. Accessed November 21, 2019.
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