Simultaneous calcineurin inhibitor avoidance (CNIA) and early corticosteroid withdrawal (ESW) have not been achieved primarily due to excessive acute rejection. This trial compared 2 belatacept-based CNIA/ESW regimens with a tacrolimus-based ESW regimen. Kidney transplant recipients were randomized to receive alemtuzumab/belatacept, rabbit anti-thymocyte globulin (rATG)/belatacept, or rATG/tacrolimus. The combinatorial primary endpoint consisted of patient death, renal allograft loss, or a Modification of Diet in Renal Disease-calculated eGFR of <45 mL/min/1.73 m2 at 12 months. Results are reported by treatment group (alemtuzumab/belatacept, rATG/belatacept, and rATG/tacrolimus). Superiority was not observed at 1 year for the primary endpoint (9/107 [8.4%], 15/104 [14.4%], and 14/105 [13.3%], respectively; P = NS) for either belatacept-based regimen. Differences were not observed for secondary endpoints (death, death-censored graft loss, or estimated glomerular filtration rates < 45 mL/min/1.73 m2 ). Differences were observed in biopsy-proved acute cellular rejection (10.3%, 18.3%, and 1.9%, respectively) (P < .001), but not in antibody-mediated rejection, mixed acute rejection, or de novo donor-specific anti-HLA antibodies. Neurologic and electrolyte abnormality adverse events were less frequent under belatacept. Belatacept-based CNIA/ESW regimens did not prove to be superior for the primary or secondary endpoints. Belatacept-treated patients demonstrated an increase in biopsy-proved acute cellular rejection and reduced neurologic and metabolic adverse events. These results demonstrate that simultaneous CNIA/ESW is feasible without excessive acute rejection.

中文翻译：

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基于 Belatacept 的免疫抑制同时避免钙调神经磷酸酶抑制剂和早期皮质类固醇戒断：一项前瞻性随机多中心试验。

同时避免钙调磷酸酶抑制剂 (CNIA) 和早期皮质类固醇戒断 (ESW) 尚未实现，主要是由于过度的急性排斥反应。该试验将 2 种基于贝拉西普的 CNIA/ESW 方案与基于他克莫司的 ESW 方案进行了比较。肾移植受者被随机分配接受阿仑单抗/贝拉西普、兔抗胸腺细胞球蛋白 (rATG)/贝拉西普或 rATG/他克莫司。组合的主要终点包括患者死亡、肾同种异体移植物丢失或 12 个月时根据肾脏疾病饮食调整计算的 eGFR <45 mL/min/1.73 m2。结果按治疗组（alemtuzumab/belatacept、rATG/belatacept 和 rATG/tacrolimus）报告。主要终点在 1 年时未观察到优效性（分别为 9/107 [8.4%]、15/104 [14.4%] 和 14/105 [13.3%]；P = NS) 对于任一基于 belatacept 的方案。未观察到次要终点（死亡、死亡审查的移植物丢失或估计的肾小球滤过率 < 45 mL/min/1.73 m2）的差异。在活检证实的急性细胞排斥反应（分别为 10.3%、18.3% 和 1.9%）（P < .001）中观察到差异，但在抗体介导的排斥反应、混合急性排斥反应或新生供体特异性抗HLA 抗体。在 belatacept 下，神经系统和电解质异常不良事件发生率较低。基于 Belatacept 的 CNIA/ESW 方案并未证明在主要或次要终点方面具有优势。Belatacept 治疗的患者表现出活检证实的急性细胞排斥反应增加，神经和代谢不良事件减少。