Background: At 3 and 5yrs post-transplant, BENEFIT-EXT showed a renal function benefit and consistent safety in belatacept (bela) treated pts vs cyclosporine (CsA). Final 7 yr results for all randomized pts in BENEFIT-EXT are reported herein.

Methods: Recipients of extended criteria donor kidneys were randomized to more (MI) or less (LI) intensive bela or CsA. 7 yr outcomes were assessed among all randomized and transplanted pts. In a prospective, post hoc, exploratory analysis, time to death or graft loss was compared between treatment groups using a Cox regression analysis. HR estimates and 95% CIs are provided.

Results: BENEFIT-EXT included 184 bela MI, 175 bela LI and 184 CsA pts; 74 MI, 84 LI and 57 CsA pts completed 7 yrs. Over 7 yrs, HR estimates comparing time to death/graft loss were 0.932 for MI vs CsA and 0.944 for LI vs CsA (Fig). Mean cGFR (MDRD) was 57.6 (MI), 59.1 (LI) and 44.6 (CsA) mL/min/1.73m². Rate of freedom from death/graft loss/cGFR <30 mL/min/1.73m² was 53% MI, 55% LI and 36% CsA. Acute rejection occurred in 19% of pts in both bela (MI and LI) groups and 16% of the CsA group. SAEs occurred in 87% MI, 89% LI and 84% CsA pts. Across MI, LI and CsA, respectively, incidence per 100 person-yrs of serious infections (21.7, 15.8, 19.6); viral infections (21.0, 17.5, 19.1); fungal infections (9.8, 6.9, 11.0) and malignancies (3.7, 3.1, 3.4), were similar. 10 PTLD cases were observed: 2 MI (1 EBV+ [per 100 person-yrs, 0.11] and 1 EBV- [1.61]); 7 LI (2 EBV+ [0.23] and 5 EBV- [6.10]); and 1 CsA (EBV+ [0.13]).

Conclusions: At 7-yrs post-transplant, bela was associated with sustained improvement in renal function vs CsA. The bela safety profile was consistent with past reports.

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