Background: Kidney transplant recipients treated with belatacept-based immunosuppression in the BENEFIT-EXT study had comparable patient and graft survival and better renal function vs a cyclosporine-based regimen. The current report assesses the safety, tolerability, and renal function associated with belatacept-based treatment at 5 yrs post-transplant among patients who entered the long-term extension (LTE).
Methods: BENEFIT-EXT was a 3-year, phase III study in recipients of extended criteria donor kidneys who were randomized to a more intensive (MI) or less intensive (LI) belatacept regimen, or cyclosporine (CsA). Patients who remained on assigned therapy at randomization through year 3 were eligible to enter the LTE.
Results: 304 (56% of intent-to-treat [ITT]) patients who completed 3 years of treatment entered the LTE (n=104 MI; n=113 LI; n=87 CsA), and 260 (48% of ITT) continued treatment through year 5 (n=91 MI; n=100 LI; n=69 CsA). 20 patients died from the beginning of the LTE to year 5 (n=5 MI; n=9 LI; n=6 CsA) and 8 experienced graft loss (n=2 MI; n=1 LI; n=5 CsA). 3 patients experienced an acute rejection episode (n=2 MI; n=1 LI). 70 patients (n=20 MI; n=26 LI; n=24 CsA) had serious infections, and 27 (n=10 MI; n=8 LI; n=9 CsA) had malignancies (including PTLD). 4 cases of PTLD occurred from the beginning of the LTE to year 5 (n=3 LI; n=1 CsA). 2/3 PTLD cases in the LI group were in patients who were seronegative for the Epstein-Barr virus at transplantation. Mean ± SD cGFR (MDRD) at year 5 was 55.9 ± 17.5 (MI), 59.0 ± 29.1 (LI), and 44.6 ± 16.4 (CsA) mL/min/1.73 m2.
Conclusions: For patients who entered the LTE, continued treatment with belatacept was associated with a consistent safety profile and sustained improvement in renal function vs CsA over time. No new safety findings were identified through year 5. The greatest risk for developing PTLD in belatacept-treated patients remains EBV negative serostatus at the time of transplantation.
Florman, S.: Grant/Research Support, Bristol-Myers Squibb, Other, Bristol-Myers Squibb, Advisory Board. Pestana, J.: Grant/Research Support, BMS, Speaker’s Bureau, BMS. Rial, M.: Grant/Research Support, BMS, Speaker’s Bureau, Pfizer, Astellas. Kiberd, B.: Employee, BMS. Pupim, L.: Employee, BMS.
To cite this abstract in AMA style:Florman S, Pestana J, Rial M, Rostaing L, Grinyo J, van Y, Muhlbacher F, Pupim L, Charpentier B. Long-Term Exposure to Belatacept in Recipients of Extended Criteria Donor Kidneys [abstract]. Am J Transplant. 2013; 13 (suppl 5). http://atcmeetingabstracts.com/abstract/long-term-exposure-to-belatacept-in-recipients-of-extended-criteria-donor-kidneys/. Accessed September 23, 2017.
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