Outcomes at Five Years in Black/African-American Kidney Transplant Recipients from the Long-Term Extension of the Belatacept BENEFIT and BENEFIT-EXT Studies

S. Florman, K. Rice, L. Chan, R. Zhang, M. Abouljoud, S. Steinberg, T. Pearson, L. Pupim, F. Vincenti

Mt Sinai Med Ctr, NY
Baylor Univ Med Ctr, TX
Univ of Colorado, CO
Tulane Univ, LA
Henry Ford Hosp, MI
Balboa Inst of Transpl, CA
Emory Univ, GA
BMS, NJ
UCSF Kidney Transpl Svc, CA

Meeting: 2013 American Transplant Congress

Abstract number: B935

Introduction: Previously reported long-term results of BENEFIT & BENEFIT-EXT demonstrated a consistent safety profile & sustained improvement in renal function vs CsA over time. Here we report the 5 yr post-transplant outcomes in Black/African-American (AA) bela-treated pts who entered the long-term extensions (LTE) of these studies.

Methods: BENEFIT (living or standard-criteria deceased donors) & BENEFIT-EXT (extended-criteria donors) were phase III studies of bela in more & less intensive (LI) regimens vs CsA. Pts remaining on assigned therapy through Yr 3 were eligible to enter the LTE. This posthoc analysis assessed safety & tolerability in the LTE cohort by recipient race. The approved LI regimen is the focus of this analysis.

Results: In BENEFIT & BENEFIT-EXT, 456/471 (68% of ITT) & 304/323 (56% of ITT) pts, respectively, completed 3 yrs of treatment & entered the LTEs; 81 pts were Black/AA (39 in BENEFIT & 42 in BENEFIT-EXT). Few deaths or graft losses occurred during the LTE of each study & overall differences in cGFR between bela LI & CsA in the LTE cohorts were maintained in Black/AA pts (Table). There were 2 AR episodes in BENEFIT (1 LI, 1 CsA) & 1 in BENEFIT-EXT (1 LI) between Yrs 3 & 5; none were in Black/AA pts. Rates of serious AEs & infections from randomization through Yr 5 across subgroups were consistent with the overall LTE. Among 4 cases of PTLD in BENEFIT-EXT LTE from randomization to Yr 5, 1 occurred in a Black/AA pt (EBV-, LI regimen). No PTLD cases were reported in BENEFIT LTE.

Conclusions: Although the sample size is modest, outcomes in belatacept-treated Black/AA pts at 5 yrs post-transplant appear to be comparable to those in the overall LTE population. Renal function benefit of belatacept over CsA was maintained over 5 yrs with no AR episodes in Black/AA pts during the LTE. The safety profile in the Black/AA subgroup was consistent with the overall LTE population.

**5-Yr Outcomes by Recipient Race in LTE**
	BENEFIT LTE		BENEFIT-EXT LTE
	LI (N=165)	CsA (N=136)	LI (N=113)	CsA (N=87)
Graft loss or death, n (Overall LTE)	2	10	10	10
White	1	5	1	2
Black/AA	0	1	1	2
Mean cGFR, mL/min/1.73 m² (Overall LTE)	76	53	59	45
White	72	46	53	40
Black/AA	81	39	58	34

Florman, S.: Grant/Research Support, BMS. Steinberg, S.: Other, Bristol-Myers Squibb, Support for Travel. Pupim, L.: Employee, Bristol-Myers Squibb (Belatacept). Vincenti, F.: Grant/Research Support, Bristol-Myers Squibb.

To cite this abstract in AMA style:

Florman S, Rice K, Chan L, Zhang R, Abouljoud M, Steinberg S, Pearson T, Pupim L, Vincenti F. Outcomes at Five Years in Black/African-American Kidney Transplant Recipients from the Long-Term Extension of the Belatacept BENEFIT and BENEFIT-EXT Studies [abstract]. Am J Transplant. 2013; 13 (suppl 5). https://atcmeetingabstracts.com/abstract/outcomes-at-five-years-in-blackafrican-american-kidney-transplant-recipients-from-the-long-term-extension-of-the-belatacept-benefit-and-benefit-ext-studies/. Accessed November 23, 2024.

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