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.
|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|
|Mean cGFR, mL/min/1.73 m² (Overall LTE)||76||53||59||45|
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 December 6, 2019.
« Back to 2013 American Transplant Congress