Long-Term Outcomes in Belatacept-Treated vs. Cyclosporine-Treated Recipients of Extended Criteria Donor Kidneys: Final Results from BENEFIT-EXT, a Phase III Randomized Study

In BENEFIT-EXT (NCT00114777), extended criteria donor kidney recipients were randomized to receive belatacept-based (more intense [MI] or less intense [LI]) or cyclosporine-based immunosuppression. In prior analyses, belatacept was associated with significantly better renal function versus cyclosporine. In this prospective analysis of the intent-to-treat population, efficacy and safety were compared across regimens at 7 years posttransplant. Overall, 128/184 belatacept MI-treated, 138/175 belatacept LI-treated, and 108/184 cyclosporine-treated patients contributed data to these analyses. Hazard ratios comparing time to death/graft loss were 0.915 (95% CI: 0.625, 1.339; P=0.65) for belatacept MI versus cyclosporine and 0.927 (95% CI: 0.634, 1.356; P=0.70) for belatacept LI versus cyclosporine. Estimated mean GFR±standard error at 7 years was 53.9±1.9, 54.2±1.9, and 35.3±2.0 mL/min/1.73 m(2) for belatacept MI, belatacept LI, and cyclosporine, respectively (P<0.001 for overall treatment effect). Hazard ratios comparing freedom from death, graft loss, or estimated GFR