title: Long-Term Outcomes in Belatacept- Versus Cyclosporine-Treated Recipients of Extended Criteria Donor Kidneys: Final Results From BENEFIT-EXT, a Phase III Randomized Study.
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 m2for 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 m2were 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.
authors.affiliation: University Hôpital of Bicêtre, Le Kremlin-Bicêtre, France. antoine.durrbach@bct.aphp.fr.|Université Paris-Saclay, Plateau de Saclay, France. antoine.durrbach@bct.aphp.fr.
authors.forename: A
authors.initials: A
authors.lastname: Durrbach
authors.affiliation: Hospital do Rim, Sao Paulo, Brazil.
authors.forename: J M
authors.initials: JM
authors.lastname: Pestana
authors.affiliation: Mount Sinai Medical Center, New York, NY.
authors.forename: S
authors.initials: S
authors.lastname: Florman
authors.affiliation: Instituto de Nefrología, Buenos Aires, Argentina.
authors.forename: M
authors.initials: M
authors.lastname: Del Carmen Rial
authors.affiliation: University Hospital, Toulouse, France.
authors.forename: L
authors.initials: L
authors.lastname: Rostaing
authors.affiliation: University Hospitals Leuven, Leuven, Belgium.
authors.forename: D
authors.initials: D
authors.lastname: Kuypers
authors.affiliation: University of Minnesota, Minneapolis, MN.
authors.forename: A
authors.initials: A
authors.lastname: Matas
authors.affiliation: Medical University of Vienna, Vienna, Austria.
authors.forename: T
authors.initials: T
authors.lastname: Wekerle
authors.affiliation: Bristol-Myers Squibb, Lawrenceville, NJ.
authors.forename: M
authors.initials: M
authors.lastname: Polinsky
authors.affiliation: Bristol-Myers Squibb, Lawrenceville, NJ.
authors.forename: H U
authors.initials: HU
authors.lastname: Meier-Kriesche
authors.affiliation: Bristol-Myers Squibb, Braine-l'Alleud, Belgium.
authors.forename: S
authors.initials: S
authors.lastname: Munier
authors.affiliation: University Hospital Bellvitge, Barcelona, Spain.
authors.forename: J M
authors.initials: JM
authors.lastname: Grinyó
mesh_terms: D000069594:Abatacept / Q000627:therapeutic use*; D016572:Cyclosporine / Q000627:therapeutic use*; D005260:Female; D005500:Follow-Up Studies; D005919:Glomerular Filtration Rate; D006084:Graft Rejection / Q000517:prevention & control*; D006085:Graft Survival; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use*; D007676:Kidney Failure, Chronic / Q000601:surgery*; D007677:Kidney Function Tests; D016030:Kidney Transplantation; D008297:Male; D008875:Middle Aged; D011379:Prognosis; D011446:Prospective Studies; D012307:Risk Factors
chemical_list: D007166:Immunosuppressive Agents; D000069594:Abatacept; D016572:Cyclosporine
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