Trial of Nemolizumab in Moderate-to-Severe Prurigo Nodularis
Trial of Nemolizumab in Moderate-to-Severe Prurigo Nodularis
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DOI：
10.1056/nejmoa1908316
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发表时间：
2020-02-20
影响因子：
158.5
通讯作者：
Piketty, Christophe
中科院分区：
文献类型：
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作者：
Staender, Sonja;Yosipovitch, Gil;Piketty, Christophe
背景 结节性痒疹是一种慢性瘙痒性皮肤病，伴有多发性结节性皮肤损害。 Nemolizumab 是一种针对白介素 31 受体的单克隆抗体，该受体参与结节性痒疹的发病机制。 方法 我们在中度至重度瘙痒症患者中进行了一项为期 12 周、随机、双盲、2 期试验，在基线、第 4 周和第 8 周，与安慰剂相比，在基线、第 4 周和第 8 周皮下注射 Nemolizumab（剂量为 0.5 mg/kg 体重）。结节性痒疹和严重瘙痒。中度至重度结节性瘙痒症被定义为 20 个或更多结节，重度瘙痒被定义为在数字评分量表上每日最严重瘙痒强度的平均分数至少为 7 分（分数范围从 0 [不痒] 到 10 [可想象的最严重瘙痒]）。主要结果是第 4 周时瘙痒症数值评分量表的平均峰值评分相对于基线的变化百分比。次要结果包括瘙痒和疾病严重程度的其他指标。安全性评估在第 18 周进行。 结果 总共 70 名患者以 1:1 的比例随机分配接受奈莫利珠单抗（34 名患者）或安慰剂（36 名）。每组的初始瘙痒数值评分均为 8.4。第 4 周时，奈莫利珠单抗组的数字评分量表的峰值瘙痒评分较基线降低了 4.5 分（变化，-53.0%），而安慰剂组则降低了 1.7 分（变化，-20.2%）（差异，-32.8 个百分点；95% 置信区间，-46.8 至 -18.8；P
Background Prurigo nodularis is a chronic pruritic skin disease with multiple nodular skin lesions. Nemolizumab is a monoclonal antibody targeting the interleukin-31 receptor, which is involved in the pathogenesis of prurigo nodularis.Methods We conducted a 12-week, randomized, double-blind, phase 2 trial of nemolizumab (at a dose of 0.5 mg per kilogram of body weight) administered subcutaneously at baseline, week 4, and week 8, as compared with placebo, in patients with moderate-to-severe prurigo nodularis and severe pruritus. Moderate-to-severe prurigo nodularis was defined as 20 or more nodules, and severe pruritus was defined as a mean score of at least 7 for the worst daily intensity of pruritus on the numerical rating scale (scores range from 0 [no itch] to 10 [worst itch imaginable]). The primary outcome was the percent change from baseline in the mean peak score for pruritus on the numerical rating scale at week 4. Secondary outcomes included additional measures of itching and disease severity. Safety assessments were performed through week 18.Results A total of 70 patients were randomly assigned in a 1:1 ratio to receive nemolizumab (34 patients) or placebo (36). The initial pruritus score on the numerical rating scale was 8.4 in each group. At week 4, the peak pruritus score on the numerical rating scale was reduced from baseline by 4.5 points (change, -53.0%) in the nemolizumab group, as compared with a reduction of 1.7 points (change, -20.2%) in the placebo group (difference, -32.8 percentage points; 95% confidence interval, -46.8 to -18.8; P