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Belatacept and long-term outcomes in kidney transplantation
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Background: 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. Methods: 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). Results: 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. Conclusions: 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; ClinicalTrials.gov number, NCT00256750).
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VINCENTI, Flavio, ROSTAING, Lionel, GRINYÓ BOIRA, Josep m., RICE, Kim, STEINBERG, Steven, GAITE, Luis, MOAL, Marie-christine, MONDRAGON-RAMÍREZ, Guillermo a., KOTHARI, Jatin, POLINSKY, Martin s., MEIER-KRIESCHE, Herwig-ulf, MUNIER, Stephane, LARSEN, Christian p.. Belatacept and long-term outcomes in kidney transplantation. _New England Journal of Medicine_. 2016. Vol. 374, núm. 4, pàgs. 333-343. [consulta: 20 de gener de 2026]. ISSN: 0028-4793. [Disponible a: https://hdl.handle.net/2445/178537]