NEJM:皮下注射Nemolizumab治疗特应性皮炎瘙痒

2020-07-09 MedSci原创 MedSci原创

皮下注射Nemolizumab与外用药物治疗显著缓解特应性皮炎瘙痒发生率和严重程度

Nemolizumab是一种皮下注射的人源抗白细胞介素-31受体A单克隆抗体,可用于治疗特应性皮炎引起的瘙痒和炎症。在II期研究中,研究人员考察了Nemolizumab对特应性皮炎严重程度的治疗效果。
 
在为期16周的试验中,来自日本的特应性皮炎患者参与,患者伴有中重度瘙痒且对外用药物反应不佳,患者随机每4周接受一次nemolizumab(60毫克)或安慰剂,直到第16周,同时使用外用药物。研究的主要终点是从基线检查到第16周瘙痒评估(VAS)评分的平均百分比变化(范围为0到100,分数越高表示瘙痒越严重)。次要终点包括到第4周瘙痒的VAS评分变化,湿疹面积和严重程度指数(EASI)评分的变化(范围为0到72,得分越高表示越严重),皮肤科生活质量指数得分4分或以下(DLQI;范围0到30,得分越高,说明越严重),失眠严重程度和安全性指数得分为7分或以下(ISI;范围为0至28,得分越高表示越严重)。
 
143名患者接受nemolizumab治疗,72名接受安慰剂治疗。在基线检查时,患者瘙痒VAS评分中位数为75。在第16周,Nemolizumab组VAS评分的平均变化百分比为-42.8%,安慰剂组为-21.4%(差异为-21.5%)。Nemolizumab组EASI评分的平均变化百分比为-45.9%,安慰剂组为-33.2%。在Nemolizumab组DLQI评分为4分或更少的患者百分比为40%,安慰剂组为22%;Nemolizumab组ISI评分为7分或以下的患者百分比分别为55%,安慰剂组为21%。Nemolizumab和安慰剂组注射相关反应的发生率分别为8%和3%。
 
研究认为,皮下注射Nemolizumab与外用药物治疗显著缓解特应性皮炎瘙痒发生率和严重程度。
 
原始出处:
 
Kenji Kabashima et al. Trial of Nemolizumab and Topical Agents for Atopic Dermatitis with Pruritus. N Engl J Med, July 9, 2020.

 

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    2020-09-12 snf701207
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    2020-07-11 listen318
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    2020-07-09 旺医

    顶刊就是顶刊,谢谢梅斯带来这么高水平的研究报道,我们科里同事经常看梅斯,分享梅斯上的信息

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