Three-Year Outcomes from BENEFIT, a Randomized, Active-Controlled, Parallel-Group Study in Adult Kidney Transplant Recipients
Three-Year Outcomes from BENEFIT, a Randomized, Active-Controlled, Parallel-Group Study in Adult Kidney Transplant Recipients
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DOI：
10.1111/j.1600-6143.2011.03785.x
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发表时间：
2012-01-01
影响因子：
8.8
通讯作者：
Charpentier, B.
中科院分区：
文献类型：
--
作者：
Vincenti, F.;Larsen, C. P.;Charpentier, B.
评估肾移植受者贝拉泰普的临床资料，以确定早期效益研究的结果是否持续3年。Benefit是一项为期3年的随机第三阶段研究，对象是接受活体或标准已故供者肾移植的成年人。患者被随机分为大强度(MI)或小强度(LI)的贝拉塔塞特或环孢素A。471/666名患者完成治疗=3年。共有92%(MI)、92%(LI)和89%(环孢素)的患者在功能正常的移植物中存活。在第3年，与环孢素组相比，贝拉泰组的平均计算肾小球滤过率(CGFR)高出21mL/min/1.73m2。从第3个月到第36个月，贝拉泰组的平均cGFR增加了+1.0mL/min/1.73m2/年(MI)和+1.2mL/min/1.73m2/年(LI)，而环孢素组则下降了-2.0mL/min/1.73m2/年。1例接受环孢素治疗的患者在第2年至第3年发生了急性排斥反应。18个月后没有新的安全信号，也没有新的移植后淋巴增生性疾病(PTLD)病例。尽管早期急性排斥和PTLD的发生率增加，但接受贝拉塔塞特治疗的患者保持了与接受环孢素A治疗的患者相当的高患者和移植物存活率。
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.