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

Research output: Contribution to journalArticlepeer-review

64 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

Bibliographical note

Funding Information:
The authors would like to thank the BENEFIT-EXT investigators (see Supporting Information for complete list). Professional medical writing and editorial assistance were provided by Tiffany DeSimone, PhD, of CodonMedical, an Ashfield Company, part of UDG Healthcare plc, and were funded by Bristol-Myers Squibb.

Publisher Copyright:
© Copyright 2016 The American Society of Transplantation and the American Society of Transplant Surgeons

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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