Long‐Term Outcomes in Belatacept‐ Versus Cyclosporine‐Treated Recipients of Extended Criteria Donor Kidneys: Final Results From BENEFIT‐EXT, a Phase III Randomized Study. Issue 11 (9th June 2016)

• Record Type: Journal Article
• Authors: Durrbach, A.; Pestana, J. M.; Florman, S.; del Carmen Rial, M.; Rostaing, L.; Kuypers, D.; Matas, A.; Wekerle, T.; Polinsky, M.; Meier‐Kriesche, H. U.; Munier, S.; Grinyó, J. M.
• Is Part Of: American journal of transplantation. Volume 16:Issue 11(2016:Nov.)
• Page Start: 3192
• Page End: 3201
• Publication Date: 2016-06-09
• Subjects: clinical research/practice -- kidney transplantation/nephrology -- clinical trial -- donors and donation: deceased -- donors and donation: extended criteria -- donors and donation: donation after circulatory death (DCD) -- immunosuppressant -- fusion proteins and monoclonal antibodies: belatacept; Transplantation of organs, tissues, etc -- Periodicals; 617.95
• DOI: 10.1111/ajt.13830
• Languages: English
• ISSNs: 1600-6135

Abstract

Abstract : In the Belatacept Evaluation of Nephroprotection and Efficacy as First‐Line Immunosuppression Trial–Extended Criteria Donors (BENEFIT‐EXT), 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 compared with cyclosporine. In this prospective analysis of the intent‐to‐treat population, efficacy and safety were compared across regimens at 7 years after transplant. Overall, 128 of 184 belatacept MI–treated, 138 of 175 belatacept LI–treated and 108 of 184 cyclosporine‐treated patients contributed data to these analyses. Hazard ratios (HRs) comparing time to death or graft loss were 0.915 (95% confidence interval [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. Mean estimated GFR (eGFR) plus or minus standard error at 7 years was 53.9 ± 1.9, 54.2 ± 1.9, and 35.3 ± 2.0 mL/min per 1.73 m 2 for belatacept MI, belatacept LI and cyclosporine, respectively (p < 0.001 for overall treatment effect). HRs comparing freedom from death, graft loss or eGFR <20 mL/min per 1.73 m 2 were 0.754 (95% CI 0.536–1.061; p = 0.10) for belatacept MI versus cyclosporine and 0.706 (95% CI 0.499–0.998; p = 0.05) for belatacept LI versus cyclosporine. Acute rejection rates and safety profiles of belatacept‐ and cyclosporine‐based treatment were similar. De novo donor‐specific antibody incidence was lower for belatacept (p ≤ 0.0001). Relative to cyclosporine, belatacept was associated with similar death and graft loss and improved renal function at 7 years after transplant and had a safety profile consistent with previous reports. Abstract : In patients transplanted with an extended donation criteria kidney, belatacept‐based immunosuppression is associated with a similar death/graft loss and improved renal function at 7 years posttransplant as a cyclosporine‐based immunosuppression, with a safety profile consistent with previous reports.