Introduction: Long-term extension (LTE) results of BENEFIT-EXT demonstrated a consistent safety profile and sustained renal function improvement with belatacept vs CsA over time. Here we report 5-year outcomes by donor type in patients (pts) in the LTE.
Methods: In BENEFIT-EXT, pts received UNOS extended-criteria deceased donor (ECD), or anticipated cold ischemia time (CIT) ≥24 hrs, or donor with cardiac death (DCD) kidneys. The trial studied belatacept in more or less intensive (LI) regimens vs CsA. Pts remaining on assigned therapy through Year 3 were eligible for the LTE. This posthoc analysis assessed belatacept safety and tolerability in the LTE by donor type at 5 years. The approved belatacept LI regimen is the focus of this analysis.
Results: In BENEFIT-EXT, 204, 97 and 30 pts receiving UNOS ECD, CIT ≥24 hrs, or DCD kidneys, respectively, completed 3 years of treatment and entered the LTE. Few deaths or graft losses occurred during the LTE and improvements in cGFR with belatacept vs CsA were maintained across donor subgroups (Table). 1 LI pt (UNOS ECD) had AR during the LTE. Serious AEs and infection rates in each donor subgroup from randomization through Year 5 were consistent with the overall LTE cohort. 4 PTLD cases were reported during the LTE: 3 in LI (2 in CIT ≥24 hrs [1 EBV, 1 EBV+], 1 in unknown donor type [EBV]) and 1 in CsA (UNOS ECD [EBV+]).
Conclusions: Outcomes in belatacept-treated recipients of ECD kidney donor subgroups (UNOS, CIT ≥24 hrs, DCD) at 5 years post-transplant were consistent with those in the overall LTE cohort. Renal function benefit of belatacept was maintained across recipients of all three donor types over 5 years in the LTE.
|Belatacept LI (N=113)||CsA (N=87)|
|Graft loss or death (Overall LTE), n||10a||10|
|CIT >24 hrsb||2||1|
|Mean cGFR (Overall LTE), mL/min/1.73 m²||59||45|
|CIT >24 hrs||63||53|
Durrbach, A.: Employee, BMS. Florman, S.: Grant/Research Support, Bristol-Myers Squibb. Lehner, F.: Other, BMS, Roche, Novartis, Honoraria, BMS, Roche, Novartis, Consulting Fee. Pupim, L.: Employee, Bristol-Myers Squibb (Belatacept).
To cite this abstract in AMA style:Durrbach A, Florman S, Zhang R, Lang P, Lehner F, Massari P, Garcia V, Pupim L, Muehlbacher F. Five-Year Outcomes by Donor Type from the Long-Term Extension of the Belatacept BENEFIT-EXT Study [abstract]. Am J Transplant. 2013; 13 (suppl 5). https://atcmeetingabstracts.com/abstract/five-year-outcomes-by-donor-type-from-the-long-term-extension-of-the-belatacept-benefit-ext-study/. Accessed May 16, 2021.
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