Anti-Interleukin-31 Receptor A Antibody for Atopic Dermatitis
Anti-Interleukin-31 Receptor A Antibody for Atopic Dermatitis
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DOI：
10.1056/nejmoa1606490
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发表时间：
2017-03-02
影响因子：
158.5
通讯作者：
Kabashima, Kenji
中科院分区：
文献类型：
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作者：
Ruzicka, Thomas;Hanifin, Jon M.;Kabashima, Kenji
背景白细胞介素31可能在特应性皮炎和瘙痒的病理生物学机制中发挥作用。我们想要评估 nemolizumab (CIM331)（一种针对白细胞介素 31 受体 A 的人源化抗体）治疗特应性皮炎的有效性和安全性。方法在这项 2 期、随机、双盲、安慰剂对照、为期 12 周的试验中，我们将局部治疗未能充分控制的中度至重度特应性皮炎成人分配给 每 4 周接受皮下注射 nemolizumab（剂量为每公斤体重 0.1 mg、0.5 mg 或 2.0 mg）或安慰剂，或每 8 周接受每公斤体重 2.0 mg 探索剂量的 nemolizumab。主要终点是第 12 周时瘙痒视觉模拟评分（负值变化表示改善）相对于基线的改善百分比。次要终点包括湿疹面积和严重程度指数（EASI，负值变化表示改善）评分的变化以及特应性皮炎的体表面积。 结果 在接受随机分组的 264 名患者中，216 名 (82%) 完成了 学习。第 12 周时，每 4 周接受奈莫利珠单抗治疗的患者中，0.1 mg 组的瘙痒视觉模拟量表变化为 -43.7%，0.5 mg 组为 -59.8%，2.0 mg 组为 -63.1%，而安慰剂组为 -20.9%（P
BACKGROUNDInterleukin-31 may play a role in the pathobiologic mechanism of atopic dermatitis and pruritus. We wanted to assess the efficacy and safety of nemolizumab (CIM331), a humanized antibody against interleukin-31 receptor A, in the treatment of atopic dermatitis.METHODSIn this phase 2, randomized, double-blind, placebo-controlled, 12-week trial, we assigned adults with moderate-to-severe atopic dermatitis that was inadequately controlled by topical treatments to receive subcutaneous nemolizumab (at a dose of 0.1 mg, 0.5 mg, or 2.0 mg per kilogram of body weight) or placebo every 4 weeks or an exploratory dose of 2.0 mg of nemolizumab per kilogram every 8 weeks. The primary end point was the percentage improvement from baseline in the score on the pruritus visual-analogue scale (on which a negative change indicates improvement) at week 12. Secondary end points included changes in the score on the Eczema Area and Severity Index (EASI, on which a negative change indicates improvement), and body-surface area of atopic dermatitis.RESULTSOf 264 patients who underwent randomization, 216 (82%) completed the study. At week 12, among the patients who received nemolizumab every 4 weeks, changes on the pruritus visual-analogue scale were -43.7% in the 0.1-mg group, -59.8% in the 0.5-mg group, and -63.1% in the 2.0-mg group, versus -20.9% in the placebo group (P