University of California, San Francisco, Kidney Transplant Service, San Francisco, CA, USA.
Am J Transplant. 2012 Jan;12(1):210-7. doi: 10.1111/j.1600-6143.2011.03785.x. Epub 2011 Oct 12.
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 m(2) 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 m(2) /year (MI) and +1.2 mL/min/1.73 m(2) /year (LI) versus a decline of -2.0 mL/min/1.73 m(2) /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.
评估了贝利尤单抗在肾移植受者中的临床特征，以确定早期 BENEFIT 研究的结果是否能持续 3 年。BENEFIT 是一项随机 3 年、III 期研究，纳入了接受活体或标准标准死亡供体肾移植的成人患者。患者被随机分配至贝利尤单抗的更（MI）或更少（LI）强化方案，或环孢素。471/666 例患者完成了≥3 年的治疗。92%（MI）、92%（LI）和 89%（环孢素）的患者在移植肾功能正常的情况下存活。与环孢素相比，3 年后，贝利尤单抗组的平均估算肾小球滤过率（cGFR）高约 21ml/min/1.73m(2)。从第 3 个月到第 36 个月，贝利尤单抗组的平均 cGFR 每年增加+1.0ml/min/1.73m(2)（MI）和+1.2ml/min/1.73m(2)（LI），而环孢素组下降-2.0ml/min/1.73m(2) /年。1 例环孢素治疗的患者在第 2 年至第 3 年期间发生急性排斥反应。无新的安全性信号，无新的移植后淋巴增殖性疾病（PTLD）病例发生。尽管急性排斥反应和 PTLD 的早期发生率增加，但贝利尤单抗治疗的患者仍保持了较高的患者和移植物存活率，与环孢素治疗的患者相当。
