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

A. Durrbach, J. M. Pestana, S. Florman, M. del Carmen Rial, L. Rostaing, D. Kuypers, A. Matas, T. Wekerle, M. Polinsky, H. U. Meier-Kriesche, S. Munier, J. M. Grinyó

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56 Scopus citations

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 m2 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 m2 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.

Original languageEnglish (US)
Pages (from-to)3192-3201
Number of pages10
JournalAmerican Journal of Transplantation
Volume16
Issue number11
DOIs
StatePublished - Nov 1 2016

Keywords

  • clinical research/practice
  • clinical trial
  • donors and donation: deceased
  • donors and donation: donation after circulatory death (DCD)
  • donors and donation: extended criteria
  • fusion proteins and monoclonal antibodies: belatacept
  • immunosuppressant
  • kidney transplantation/nephrology

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    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. (2016). Long-Term Outcomes in Belatacept- Versus Cyclosporine-Treated Recipients of Extended Criteria Donor Kidneys: Final Results From BENEFIT-EXT, a Phase III Randomized Study. American Journal of Transplantation, 16(11), 3192-3201. https://doi.org/10.1111/ajt.13830