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N Engl J Med. 2016 Jan 28;374(4):333-43. doi: 10.1056/NEJMoa1506027.

Belatacept and Long-Term Outcomes in Kidney Transplantation.

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From the University of California, San Francisco, San Francisco (F.V.), and Sharp Memorial Hospital, San Diego (S.S.) - both in California; University Hospital and INSERM Unité 563, IFR-BMT, Toulouse (L.R.), and Hôpital de La Cavale Blanche, Brest (M.-C.M.) - both in France; University Hospital Bellvitge, Barcelona (J.G.); Baylor University Medical Center, Dallas (K.R.); Clínica de Nefrología, Santa Fe, Argentina (L.G.); Instituto Mexicano de Trasplantes, Morelos, Mexico (G.A.M.-R.); Hinduja Hospital, Hinduja Health Care and Apex Kidney Foundation, Mumbai, India (J.K.); Bristol-Myers Squibb, Princeton, NJ (M.S.P., H.-U.M.-K.); Bristol-Myers Squibb, Braine-l'Alleud, Belgium (S.M.); and Emory University Transplant Center, Atlanta (C.P.L.).



In previous analyses of BENEFIT, a phase 3 study, belatacept-based immunosuppression, as compared with cyclosporine-based immunosuppression, was associated with similar patient and graft survival and significantly improved renal function in kidney-transplant recipients. Here we present the final results from this study.


We randomly assigned kidney-transplant recipients to a more-intensive belatacept regimen, a less-intensive belatacept regimen, or a cyclosporine regimen. Efficacy and safety outcomes for all patients who underwent randomization and transplantation were analyzed at year 7 (month 84).


A total of 666 participants were randomly assigned to a study group and underwent transplantation. Of the 660 patients who were treated, 153 of the 219 patients treated with the more-intensive belatacept regimen, 163 of the 226 treated with the less-intensive belatacept regimen, and 131 of the 215 treated with the cyclosporine regimen were followed for the full 84-month period; all available data were used in the analysis. A 43% reduction in the risk of death or graft loss was observed for both the more-intensive and the less-intensive belatacept regimens as compared with the cyclosporine regimen (hazard ratio with the more-intensive regimen, 0.57; 95% confidence interval [CI], 0.35 to 0.95; P=0.02; hazard ratio with the less-intensive regimen, 0.57; 95% CI, 0.35 to 0.94; P=0.02), with equal contributions from the lower rates of death and graft loss. The mean estimated glomerular filtration rate (eGFR) increased over the 7-year period with both belatacept regimens but declined with the cyclosporine regimen. The cumulative frequencies of serious adverse events at month 84 were similar across treatment groups.


Seven years after transplantation, patient and graft survival and the mean eGFR were significantly higher with belatacept (both the more-intensive regimen and the less-intensive regimen) than with cyclosporine. (Funded by Bristol-Myers Squibb; number, NCT00256750.).

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