Alemtuzumab Induction in Renal Transplantation
Alemtuzumab Induction in Renal Transplantation
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DOI：
10.1056/nejmoa1009546
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发表时间：
2011-05-19
影响因子：
158.5
通讯作者：
Holman, John
中科院分区：
文献类型：
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作者：
Hanaway, Michael J.;Woodle, E. Steve;Holman, John
背景很少有抗体诱导治疗允许肾移植受者早期停用糖皮质激素的比较。本研究的目的是将阿仑单抗诱导治疗与高免疫风险或低免疫风险患者群体中最常用的诱导方案进行比较。 方法在这项前瞻性研究中，我们随机分配患者接受阿仑单抗或常规诱导治疗（巴利昔单抗或兔抗胸腺细胞球蛋白）。根据急性排斥风险对患者进行分层，高风险定义为重复移植、群体反应性抗体的峰值或当前值达到 20% 或更高，或黑人种族。 139 名高危患者接受了阿仑单抗（70 名患者一次剂量为 30 毫克）或兔抗胸腺细胞球蛋白（69 名患者在 4 天内每公斤体重总共给予 6 毫克）。 335 名低风险患者接受了阿仑单抗（一剂 30 毫克，164 名患者）或巴利昔单抗（4 天内总共 40 毫克，171 名患者）。所有患者均接受他克莫司和吗替麦考酚酯治疗，并接受为期 5 天的糖皮质激素减量治疗，即早期类固醇停药方案。主要终点是 6 个月和 12 个月时活检证实的急性排斥反应。对患者进行为期 3 年的安全性和疗效终点随访。 结果 6 个月时，阿仑单抗组活检证实的急性排斥反应率均显着低于常规治疗组（3% vs. 15%，P
BackgroundThere are few comparisons of antibody induction therapy allowing early glucocorticoid withdrawal in renal-transplant recipients. The purpose of the present study was to compare induction therapy involving alemtuzumab with the most commonly used induction regimens in patient populations at either high immunologic risk or low immunologic risk.MethodsIn this prospective study, we randomly assigned patients to receive alemtuzumab or conventional induction therapy (basiliximab or rabbit antithymocyte globulin). Patients were stratified according to acute rejection risk, with a high risk defined by a repeat transplant, a peak or current value of panel-reactive antibodies of 20% or more, or black race. The 139 high-risk patients received alemtuzumab (one dose of 30 mg, in 70 patients) or rabbit antithymocyte globulin (a total of 6 mg per kilogram of body weight given over 4 days, in 69 patients). The 335 low-risk patients received alemtuzumab (one dose of 30 mg, in 164 patients) or basiliximab (a total of 40 mg over 4 days, in 171 patients). All patients received tacrolimus and mycophenolate mofetil and underwent a 5-day glucocorticoid taper in a regimen of early steroid withdrawal. The primary end point was biopsy-confirmed acute rejection at 6 months and 12 months. Patients were followed for 3 years for safety and efficacy end points.ResultsThe rate of biopsy-confirmed acute rejection was significantly lower in the alemtuzumab group than in the conventional-therapy group at both 6 months (3% vs. 15%, P