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<0.001). Results for secondary outcomes were in the same direction as for the primary outcome. Nemolizumab was associated with gastrointestinal symptoms (abdominal pain and diarrhea) and musculoskeletal symptoms. CONCLUSIONS Nemolizumab resulted in a greater reduction in pruritus and severity of skin lesions than placebo in patients with prurigo nodularis but was associated with adverse events. Larger and longer trials are needed to determine the durability and safety of nemolizumab for the treatment of prurigo nodularis. (Funded by Galderma; ClinicalTrials.gov number, NCT03181503.).

中文翻译：

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奈莫珠单抗在中度至重度结节性瘙痒中的试验。

背景技术结节性瘙痒病是一种慢性多发性结节性皮肤病的瘙痒性皮肤病。Nemolizumab是靶向白介素31受体的单克隆抗体，与结节性瘙痒病的发病有关。方法与安慰剂相比，我们在基线，第4周和第8周皮下给予奈莫珠单抗（剂量为0.5 mg / kg体重）为期12周的随机，双盲，2期临床试验，中度至重度结节性瘙痒和严重瘙痒的患者。中度至重度瘙痒结节被定义为20个或更多结节，严重瘙痒症的定义为在数字等级量表中瘙痒最严重的每日强度的平均评分至少为7（分数从0 [无痒]至10 [最难想象的痒]）。主要结果是在第4周的数字评分量表上，瘙痒的平均峰值得分偏离基线的百分比变化。次要结果包括瘙痒和疾病严重程度的其他测量。安全评估持续到第18周。结果以1：1的比例随机分配了70例患者，接受nemolizumab（34例）或安慰剂（36例）。每组在数字评分量表上的初始瘙痒评分为8.4。在第4周，奈莫珠单抗组在数值评分量表上的瘙痒最高评分比基线降低了4.5点（改变，-53.0％），而安慰剂组降低了1.7点（改变，-20.2％）。组（差异-32.8个百分点; 95％置信区间-46.8至-18.8; P <0.001）。次要结果的结果与主要结果的方向相同。奈莫珠单抗与胃肠道症状（腹痛和腹泻）和肌肉骨骼症状有关。结论与结节性瘙痒症患者相比，奈莫珠单抗导致的瘙痒和皮肤病变严重程度的减轻幅度大于安慰剂，但与不良事件相关。需要更大和更长的试验来确定奈莫珠单抗治疗结节性瘙痒的持久性和安全性。（由Galderma资助； ClinicalTrials.gov编号，NCT03181503。）。结论与结节性瘙痒症患者相比，奈莫珠单抗导致的瘙痒和皮肤病变严重程度的减轻幅度大于安慰剂，但与不良事件相关。需要更大和更长的试验来确定奈莫珠单抗治疗结节性瘙痒的持久性和安全性。（由Galderma资助； ClinicalTrials.gov编号，NCT03181503。）。结论与结节性瘙痒症患者相比，奈莫珠单抗导致的瘙痒和皮肤病变严重程度的减轻幅度大于安慰剂，但与不良事件相关。需要更大和更长的试验来确定奈莫珠单抗治疗结节性瘙痒的持久性和安全性。（由Galderma资助； ClinicalTrials.gov编号，NCT03181503。）。