JAMA:乌司奴单抗停用后阿巴西普共刺激阻断对中重度斑块状银屑病患者的影响PAUSE 随机临床试验

2021-10-20 MedSci原创 MedSci原创

银屑病复发可能涉及在用阿巴西普阻断 CD28-CD80/CD86 的情况下的代偿性 T 细胞激活途径。确定使用阿巴西普进行共刺激信号阻断是否能防止乌司奴单抗停用后银屑病复发。

银屑病复发可能涉及在用阿巴西普阻断 CD28-CD80/CD86 的情况下的代偿性 T 细胞激活途径。确定使用阿巴西普进行共刺激信号阻断是否能防止乌司奴单抗停用后银屑病复发。

实验设计:

使用阿巴西普和乌司奴单抗治疗银屑病:疗效研究 (PAUSE),一项平行设计、双盲、安慰剂对照的随机临床试验,在美国和加拿大的 10 个地点进行。参与者招募于 2014 年 3 月 19 日开始,并于 2016 年 4 月 11 日结束。参与者是患有中度至重度斑块状银屑病并在导入阶段接受优特克单抗治疗的成年人。

 

那些在第 12 周对优特克单抗有反应的患者被按 1:1 随机分配到继续优特克单抗组(优特克单抗组)或转换为阿巴西普组(阿巴西普组)。治疗在第 39 周停止,参与者的银屑病复发随访至第 88 周。对 2018 年 5 月 3 日至 2021 年 7 月 6 日的意向治疗 (ITT) 和安全性样本进行了统计分析。

 

临床干预:

参与者在第 0 周和第 4 周接受皮下注射乌司奴单抗(≤100 kg 的患者每剂 45 mg;>100 kg 的患者每剂 90 mg)。在第 12 周随机分配到阿巴西普组的参与者在第 12 周至第 39 周接受皮下注射阿巴西普,每周 125 毫克,在第 16 周和第 28 周接受优特克单抗安慰剂。随机分配到优特克单抗组的参与者在第 16 周和第 28 周接受优特克单抗治疗,从周开始每周接受阿巴西普安慰剂12 到 39。

 

实验终点:主要终点是第 12 周和第 88 周之间银屑病复发的参与者比例(初始银屑病面积和严重性指数改善的损失≥50%)。次要终点包括银屑病复发时间、参与者比例银屑病在第 12 周和第 40 周之间复发,以及不良事件。评估了银屑病转录组和血清细胞因子。

 

结果:共有 108 名参与者(平均 [SD] 年龄,46.1 [12.1] 岁;73 名 [67.6%] 男性)接受了开放标签优特克单抗治疗;91 人随机接受盲法治疗。阿巴西普组和优特克单抗组的参与者在第 12 周和第 88 周之间复发的比例相似(45 人中的 41 人 [91.1%] vs 46 人中的 40 人 [87.0%];P  = .41)。从最后一剂优特克单抗到复发的中位时间在各组之间也相似:阿巴西普组为 36 周(95% CI,36-48 周),优特克单抗组为 32 周(95% CI,28-40 周) . 发生了相似的不良事件数量和发生率。在停用优特克单抗后,阿巴西普无法维持对病灶中致病性 IL-23 介导的银屑病分子特征的抑制,并且血清 IL-19 水平升高。

 

结论:这项平行设计、双盲随机临床试验发现,阿巴西普不能预防乌司奴单抗停用后发生的银屑病复发,因为它没有完全阻断导致复发的致病性银屑病分子途径

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