A Phase III Study of Belatacept-based Immunosuppression Regimens versus Cyclosporine in Renal Transplant Recipients (BENEFIT Study)
A Phase III Study of Belatacept-based Immunosuppression Regimens versus Cyclosporine in Renal Transplant Recipients (BENEFIT Study)
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DOI：
10.1111/j.1600-6143.2009.03005.x
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发表时间：
2010-03-01
影响因子：
8.8
通讯作者：
Larsen, C. P.
中科院分区：
文献类型：
--
作者：
Vincenti, F.;Charpentier, B.;Larsen, C. P.
贝拉西普是一种共刺激阻滞剂，与钙调神经磷酸酶抑制剂相比，在肾移植中可以保留肾功能并改善长期结果。这项 III 期研究（贝拉西普作为一线免疫抑制试验的肾保护和功效评估）在接受活体或标准标准已故捐献者肾移植的成人中评估了贝拉西普与环孢素的更高强度（MI）或更低强度（LI）方案。 12 个月时的共同主要终点是患者/移植物存活率、复合肾损伤终点（第 12 个月测量的肾小球滤过率 (mGFR) < 60 mL/min/1.73 m2 的百分比或第 3 个月至第 12 个月 mGFR 降低 >= 10 mL/min/1.73 m2）和急性排斥反应的发生率。在第 12 个月时，两种贝拉西普方案与环孢素相比具有相似的患者/移植物存活率（MI：95%，LI：97% 和环孢素：93%），并且与通过复合肾损害终点（MI：55%；LI：54% 和环孢素：78%；p < 0.001 MI 或 LI 与环孢素相比）测量的优良肾功能相关。的 mGFR（MI、LI 和环孢菌素为 65、63 和 50 mL/min；与环孢菌素相比，MI 或 LI 的 p < 0.001）。 Belatacept 患者的急性排斥反应发生率较高（MI：22%，LI：17%，环孢素：7%）和严重程度。各组之间的安全性总体相似，但移植后淋巴细胞增殖性疾病在贝拉西普组中更为常见。尽管早期急性排斥反应发生率较高，但与环孢菌素相比，贝拉西普在移植后 1 年具有优越的肾功能和相似的患者/移植物存活率。
Belatacept, a costimulation blocker, may preserve renal function and improve long-term outcomes versus calcineurin inhibitors in kidney transplantation. This Phase III study (Belatacept Evaluation of Nephroprotection and Efficacy as First-line Immunosuppression Trial) assessed a more intensive (MI) or less intensive (LI) regimen of belatacept versus cyclosporine in adults receiving a kidney transplant from living or standard criteria deceased donors. The coprimary endpoints at 12 months were patient/graft survival, a composite renal impairment endpoint (percent with a measured glomerular filtration rate (mGFR) < 60 mL/min/1.73 m2 at Month 12 or a decrease in mGFR >= 10 mL/min/1.73 m2 Month 3-Month 12) and the incidence of acute rejection. At Month 12, both belatacept regimens had similar patient/graft survival versus cyclosporine (MI: 95%, LI: 97% and cyclosporine: 93%), and were associated with superior renal function as measured by the composite renal impairment endpoint (MI: 55%; LI: 54% and cyclosporine: 78%; p < 0.001 MI or LI versus cyclosporine) and by the mGFR (65, 63 and 50 mL/min for MI, LI and cyclosporine; p < 0.001 MI or LI versus cyclosporine). Belatacept patients experienced a higher incidence (MI: 22%, LI: 17% and cyclosporine: 7%) and grade of acute rejection episodes. Safety was generally similar between groups, but posttransplant lymphoproliferative disorder was more common in the belatacept groups. Belatacept was associated with superior renal function and similar patient/graft survival versus cyclosporine at 1 year posttransplant, despite a higher rate of early acute rejection.