Treatment of lupus nephritis with abatacept: the Abatacept and Cyclophosphamide Combination Efficacy and Safety Study.
Treatment of lupus nephritis with abatacept: the Abatacept and Cyclophosphamide Combination Efficacy and Safety Study.
复制标题
DOI：
10.1002/art.38790
复制
发表时间：
2014-11
期刊：
影响因子：
--
通讯作者：
ACCESS Trial Group
中科院分区：
文献类型：
--
作者：
ACCESS Trial Group
目的：评价阿巴西普24周疗程治疗活动性狼疮性肾炎的疗效和安全性。另一项探索性目标是评估阿巴塔塞特诱导“临床耐受性”的可能性，“临床耐受性”是指狼疮性肾炎在停止免疫抑制治疗后的持续临床静止期。活动性狼疮性肾炎患者(n=134)参加了一项随机、双盲的II期附加试验，在试验中，他们接受了阿巴西普或安慰剂，同时接受低剂量环磷酰胺和硫唑嘌呤的欧洲狼疮方案。主要疗效结果是24周时完全缓解(CR)的频率。此后，符合完全或部分应答标准的患者继续盲目治疗至52周。在这一阶段的研究中，abatacept治疗组中在第24周时达到CR状态的受试者停止了除泼尼松(10 mg/d)以外的免疫抑制治疗。两组之间在主要结果或任何次要结果(包括安全措施)方面没有统计学上的显著差异。在24周时，治疗组33%的受试者和对照组31%的受试者达到CR状态。在治疗组中，符合CR标准并因此在第24周停止免疫抑制治疗的受试者中，有50%的人在第52周保持他们的CR状态。在24周或52周的狼疮性肾炎的治疗中，在环磷酰胺加硫唑嘌呤的基础上加用阿巴西普并不能改善结果。没有遇到令人担忧的安全信号。
To assess the efficacy and safety of a 24-week course of abatacept in the treatment of active lupus nephritis. An additional exploratory objective was to assess the potential of abatacept to induce ‘clinical tolerance’, defined as sustained clinical quiescence of lupus nephritis after discontinuation of immunosuppressive therapy. Patients (n=134) with active lupus nephritis were studied in a randomized, double-blind phase II add-on trial in which they received either abatacept or placebo in conjunction with the Euro-Lupus regimen of low-dose cyclophosphamide followed by azathioprine. The primary efficacy outcome was the frequency of complete response (CR) at week 24. Thereafter, patients who met either complete or partial response criteria continued blinded treatment through week 52. During this phase of the study, subjects in the abatacept treatment group who had achieved CR status at week 24 discontinued immunosuppressive therapy other than prednisone (10 mg/d). There were no statistically significant differences between groups with respect to the primary outcome or any of the secondary outcomes, including measures of safety. Thirty-three percent of subjects in the treatment group and 31% of subjects in the control group achieved CR status at week 24. Fifty percent of subjects in the treatment group who met CR criteria and therefore discontinued immunosuppressive therapy at week 24 maintained their CR status through week 52. The addition of abatacept to a regimen of cyclophosphamide followed by azathioprine did not improve the outcome of lupus nephritis at either 24 or 52 weeks. No worrisome safety signals were encountered.