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Five-Year Outcomes by Donor Type from the Long-Term Extension of the Belatacept BENEFIT-EXT Study

A. Durrbach, S. Florman, R. Zhang, P. Lang, F. Lehner, P. Massari, V. Garcia, L. Pupim, F. Muehlbacher

Bicêtre Hosp, France
Mt Sinai Med Cntr, NY
Tulane Univ, LA
Hôpital Henri Mondor, France
Med Hochschule Hannover, Germany
Univ Catolica de Cordoba, Argentina
Hosp Dom Vicente Scherer, Brazil
BMS, NJ
Medical Univ of Vienna, Austria

Meeting: 2013 American Transplant Congress

Abstract number: B933

Related Abstracts
  • Likelihood of Improving or Maintaining Renal Function in Recipients of Extended-Criteria Donor Kidneys over Five Years with Belatacept or CsA (BENEFIT-EXT Long-Term Extension Study)
  • Outcomes at Five Years in Black/African-American Kidney Transplant Recipients from the Long-Term Extension of the Belatacept BENEFIT and BENEFIT-EXT Studies

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.

5-Year Outcomes by Donor Type in BENEFIT-EXT LTE
  Belatacept LI (N=113) CsA (N=87)
Graft loss or death (Overall LTE), n 10a 10
UNOS ECDb 6 9
CIT >24 hrsb 2 1
DCDb 1 2
Mean cGFR (Overall LTE), mL/min/1.73 m² 59 45
UNOS ECD 49 31
CIT >24 hrs 63 53
DCD 61 35
aIncludes 2 pts with unknown donor type; bECD kidneys could meet >1 condition

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).

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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 January 25, 2021.

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