*Drs. Vincenti and Larsen contributed equally to the work described.
Three-Year Outcomes from BENEFIT, a Randomized, Active-Controlled, Parallel-Group Study in Adult Kidney Transplant Recipients
Article first published online: 12 OCT 2011
©Copyright 2011 The American Society of Transplantation and the American Society of Transplant Surgeons
American Journal of Transplantation
Volume 12, Issue 1, pages 210–217, January 2012
How to Cite
Vincenti, F., Larsen, C. P., Alberu, J., Bresnahan, B., Garcia, V. D., Kothari, J., Lang, P., Urrea, E. M., Massari, P., Mondragon-Ramirez, G., Reyes-Acevedo, R., Rice, K., Rostaing, L., Steinberg, S., Xing, J., Agarwal, M., Harler, M. B. and Charpentier, B. (2012), Three-Year Outcomes from BENEFIT, a Randomized, Active-Controlled, Parallel-Group Study in Adult Kidney Transplant Recipients. American Journal of Transplantation, 12: 210–217. doi: 10.1111/j.1600-6143.2011.03785.x
- Issue published online: 13 JAN 2012
- Article first published online: 12 OCT 2011
- Received 30 March 2011, revised 04 August 2011 and accepted for publication 11 August 2011
- renal function
The clinical profile of belatacept in kidney transplant recipients was evaluated to determine if earlier results in the BENEFIT study were sustained at 3 years. BENEFIT is a randomized 3 year, phase III study in adults receiving a kidney transplant from a living or standard criteria deceased donor. Patients were randomized to a more (MI) or less intensive (LI) regimen of belatacept, or cyclosporine. 471/666 patients completed ≥3 years of therapy. A total of 92% (MI), 92% (LI), and 89% (cyclosporine) of patients survived with a functioning graft. The mean calculated GFR (cGFR) was ∼21 mL/min/1.73 m2 higher in the belatacept groups versus cyclosporine at year 3. From month 3 to month 36, the mean cGFR increased in the belatacept groups by +1.0 mL/min/1.73 m2/year (MI) and +1.2 mL/min/1.73 m2/year (LI) versus a decline of −2.0 mL/min/1.73 m2/year (cyclosporine). One cyclosporine-treated patient experienced acute rejection between year 2 and year 3. There were no new safety signals and no new posttransplant lymphoproliferative disorder (PTLD) cases after month 18. Belatacept-treated patients maintained a high rate of patient and graft survival that was comparable to cyclosporine-treated patients, despite an early increased occurrence of acute rejection and PTLD.