期刊
AMERICAN JOURNAL OF TRANSPLANTATION
卷 12, 期 1, 页码 210-217出版社
WILEY
DOI: 10.1111/j.1600-6143.2011.03785.x
关键词
Belatacept; cyclosporine; kidney; renal function
资金
- Bristol-Myers Squibb
- Genentech
- Pfizer
- Novartis
- Astellas Pharma
- Genzyme
- Roche
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 similar to 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.
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