Transplant Center, University of Colorado Denver, Aurora, CO 80045, USA.
Transplantation. 2010 Sep 27;90(6):639-44. doi: 10.1097/TP.0b013e3181ea6788.
IL2 receptor antagonist (IL2ra) induction therapy has gained favor due to an excellent safety profile and improved outcomes in randomized trials using cyclosporine-based immunosuppression. However, there have been no large randomized trials or retrospective analyses examining the effect of IL2ra versus no induction using tacrolimus and mycophenolate (TAC/MPA)-based therapy.
A retrospective analysis from the Scientific Renal Transplant Registry of adult, primary kidney transplant recipients from 2000 to 2008 with initial immunosuppression of TAC/MPA and prednisone, who received IL2ra induction therapy or no induction therapy (n=28,686) was performed. The primary outcome was acute rejection at 1 year, and secondary outcomes were graft and patient survival at 1 and 3 years. Multivariable analysis was used to control for factors shown to influence the incidence of acute rejection, and separate analyses were performed for deceased versus living donors.
Acute rejection at 1 year was significantly lower with IL2ra (11.6%) versus no induction therapy (13.0%; P=0.001). One-year (95.7% vs. 95.8%) and 3-year (87.5% vs. 87.8%) graft survival, and 1-year (97.4% vs. 97.5%) and 3-year (92.8% vs. 93.2%) patient survival, was not different between those receiving IL2ra and no induction therapy. On multivariable analysis, the relative risk of acute rejection with IL2ra was 0.90 (95% CI, 0.85-0.96; P=0.001), and the effect was greater in living donors (relative risk, 0.82; P<0.001) than deceased donors (relative risk, 0.95; P=0.23).
The benefit of IL2ra induction with TAC/MPA/prednisone maintenance immunosuppression is less than previously reported due to a low baseline incidence of acute rejection.
白细胞介素 2 受体拮抗剂（IL2ra）诱导治疗因具有极好的安全性和改善随机试验中基于环孢素的免疫抑制治疗的结果而受到青睐。然而，尚没有使用他克莫司和霉酚酸酯（TAC/MPA）为基础的治疗的大的随机试验或回顾性分析来检验 IL2ra 与无诱导治疗的效果。
对 2000 年至 2008 年接受初始 TAC/MPA 和泼尼松免疫抑制治疗的成年原发性肾移植受者的科学肾移植登记处进行回顾性分析，这些受者接受了白细胞介素 2 受体拮抗剂（IL2ra）诱导治疗或未接受诱导治疗（n=28686）。主要结局是 1 年时的急性排斥反应，次要结局是 1 年和 3 年时的移植物和患者存活率。多变量分析用于控制已知影响急性排斥反应发生率的因素，并且分别对已故供体和活体供体进行分析。
IL2ra 组（11.6%）1 年时的急性排斥反应明显低于未诱导治疗组（13.0%；P=0.001）。IL2ra 组与未诱导治疗组 1 年（95.7%比 95.8%）和 3 年（87.5%比 87.8%）移植物存活率以及 1 年（97.4%比 97.5%）和 3 年（92.8%比 93.2%）患者存活率无差异。多变量分析显示，IL2ra 治疗的急性排斥反应相对风险为 0.90（95%CI，0.85-0.96；P=0.001），并且在活体供体中作用更大（相对风险，0.82；P<0.001），而在已故供体中作用较小（相对风险，0.95；P=0.23）。
由于急性排斥反应的基线发生率较低，TAC/MPA/泼尼松维持免疫抑制治疗中白细胞介素 2 受体拮抗剂（IL2ra）诱导治疗的获益小于先前报道的结果。
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