Background

The substance P/neurokinin 1 receptor pathway is critical in chronic pruritus; anecdotal evidence suggests that antagonism of this pathway can reduce chronic itch.

Objective

To assess the safety and efficacy of the substance P/neurokinin 1 receptor antagonist serlopitant in treating chronic pruritus.

Methods

Eligible patients with severe chronic pruritus who were refractory to antihistamines or topical steroids were randomized to serlopitant, 0.25, 1, or 5 mg, or to placebo, administered once daily for 6 weeks as monotherapy or with midpotency steroids and emollients. The primary efficacy end point was percentage change in visual analog scale pruritus score from baseline.

Results

Serlopitant treatment resulted in a dose-dependent decrease in pruritus. The mean percentage decreases from baseline visual analog scale pruritus scores were statistically significantly larger with the 1- and 5-mg doses of serlopitant (P = .022 and P = .013, respectively) than with placebo at week 6. No significant safety or tolerability differences were detected among the groups.

Limitations

The sample size was insufficient for subgroup analyses of the efficacy of serlopitant for chronic pruritus on the basis of underlying conditions.

Conclusions

Serlopitant, 1 mg and 5 mg daily, was associated with a statistically significant reduction in chronic pruritus and was well tolerated (NCT01951274).

中文翻译：

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舍洛匹坦治疗慢性瘙痒症：一项随机，多中心，安慰剂对照的2期临床试验的结果

背景

P /神经激肽1受体物质在慢性瘙痒症中起关键作用。轶事证据表明，该途径的拮抗作用可减少慢性瘙痒。

客观的

评估P /神经激肽1受体拮抗剂舍洛匹坦在治疗慢性瘙痒症中的安全性和有效性。

方法

对抗组胺药或局部类固醇难治的重度慢性瘙痒病的合格患者，随机分为serlopitant，0.25、1或5 mg或安慰剂，每天一次，连续6周作为单一疗法或与中效类固醇和润肤剂一起服用。主要功效终点是视觉模拟量表瘙痒评分相对于基线的百分比变化。

结果

Serlopitant治疗导致瘙痒的剂量依赖性降低。在1周和5 mg剂量的serlopitant时，从基线视觉类似物瘙痒评分的平均下降百分比在统计学上均显着大于 安慰剂（在第6周时分别为P  = .022和P = .013）。在各组之间检测到耐受性差异。

局限性

样本量不足以根据潜在疾病对亚硝胺对慢性瘙痒的疗效进行亚组分析。

结论

Serlopitant每天1 mg和5 mg，与慢性瘙痒的统计显着减少有关，并且耐受性良好（NCT01951274）。