New data from the BENEFIT study demonstrate that belatacept improves long-term allograft and patient survival after kidney transplantation, despite higher rates of biopsy-proven acute rejection than with ciclosporin. The noninferiority design of BENEFIT represents a feasible strategy to further the development of innovator drugs to reduce late graft loss.
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References
Vincenti, F. et al. Belatacept and long-term outcomes in kidney transplantation. N. Engl. J. Med. 374, 333–343 (2016).
Lamb, K. E., Lodhi, S. & Meier-Kriesche, H. U. Long-term renal allograft survival in the United States: a critical reappraisal. Am. J. Transplant. 11, 450–462 (2011).
Vincenti, F. et al. A phase III study of belatacept-based immunosuppression regimens versus cyclosporine in renal transplant recipients (BENEFIT study). Am. J. Transplant. 10, 535–546 (2010).
Durrbach, A. et al. A phase III study of belatacept versus cyclosporine in kidney transplants from extended criteria donors (BENEFIT-EXT study). Am. J. Transplant. 10, 547–557 (2010).
Halloran, P. F., Reeve, J. P., Pereira, A. B., Hidalgo, L. G. & Famulski, K. S. Antibody-mediated rejection, T cell-mediated rejection, and the injury-repair response: new insights from the Genome Canada studies of kidney transplant biopsies. Kidney Int. 85, 258–264 (2014).
Rostaing, L. et al. Long-term belatacept exposure maintains efficacy and safety at 5 years: results from the long-term extension of the BENEFIT study. Am. J. Transplant. 13, 2875–2883 (2013).
Jardine, A. G., Gaston, R. S., Fellstrom, B. C. & Holdaas, H. Prevention of cardiovascular disease in adult recipients of kidney transplants. Lancet 378, 1419–1427 (2011).
Archdeacon, P., Dixon, C., Belen, O., Albrecht, R. & Meyer, J. Summary of the US FDA approval of belatacept. Am. J. Transplant. 12, 554–562 (2012).
Schold, J. D. & Kaplan, B. The elephant in the room: failings of current clinical endpoints in kidney transplantation. Am. J. Transplant. 10, 1163–1166 (2010).
Piaggio, G. et al. Reporting of noninferiority and equivalence randomized trials: extension of the CONSORT 2010 statement. JAMA 308, 2594–2604 (2012).
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Naesens, M., Thaunat, O. BENEFIT of belatacept: kidney transplantation moves forward. Nat Rev Nephrol 12, 261–262 (2016). https://doi.org/10.1038/nrneph.2016.34
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DOI: https://doi.org/10.1038/nrneph.2016.34
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