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一项为期 24 周的随机临床试验,旨在研究两种剂量依那西普治疗指甲银屑病的疗效和安全性。

A 24-week randomized clinical trial investigating the efficacy and safety of two doses of etanercept in nail psoriasis.

机构信息

Service de Dermatologie, Hôpital L'Archet 2, 151 route St-Antoine de Ginestière, 06202 Nice Cedex 3, France.

出版信息

Br J Dermatol. 2013 May;168(5):1080-7. doi: 10.1111/bjd.12060.

Abstract

BACKGROUND

Nail psoriasis is common in patients with psoriasis and can seriously affect their quality of life. Current treatments are limited and there is no standard course of therapy.

OBJECTIVES

To assess the efficacy and safety of etanercept (ETN) on nail psoriasis in patients with moderate-to-severe psoriasis.

METHODS

Patients with moderate-to-severe plaque psoriasis, who had previously failed at least one form of systemic therapy for nail psoriasis, were randomized to receive open-label ETN 50 mg twice weekly (BIW) for 12 weeks followed by once weekly (QW) for 12 weeks (BIW/QW group) or ETN 50 mg QW for 24 weeks (QW/QW group). The primary endpoint was the mean improvement in the Nail Psoriasis Severity Index (NAPSI; score range 0-8) over 24 weeks in the target fingernail with the most severe abnormalities.

RESULTS

Seventy-two patients received one or more doses of ETN (38 BIW/QW; 34 QW/QW) and 69 patients were included in the modified intent-to-treat population. At baseline, mean (standard error) target fingernail NAPSI score was 6.0 (0.3) in the BIW/QW group and 5.8 (0.3) in the QW/QW group. At week 24, mean target fingernail NAPSI score had decreased significantly by -4.3 [95% confidence interval (CI) -4.9 to -3.7; P < 0.0001] in the BIW/QW group and by -4.4 (95% CI -5.0 to -3.7; P < 0.0001) in the QW/QW group. Improvement in NAPSI showed significant correlation with Psoriasis Area and Severity Index improvement. ETN was well tolerated with no unexpected safety findings.

CONCLUSIONS

Both ETN regimens were effective at treating nail psoriasis in this patient population.

摘要

背景

指甲银屑病在银屑病患者中很常见,会严重影响他们的生活质量。目前的治疗方法有限,没有标准的治疗方案。

目的

评估依那西普(ETN)对中重度银屑病患者指甲银屑病的疗效和安全性。

方法

将既往至少一种全身治疗方案治疗指甲银屑病失败的中重度斑块状银屑病患者随机分为两组,分别接受依那西普 50mg 每周 2 次(BIW)治疗 12 周,然后每周 1 次(QW)治疗 12 周(BIW/QW 组)或依那西普 50mg QW 治疗 24 周(QW/QW 组)。主要终点是在 24 周内目标指甲中最严重病变指甲银屑病严重程度指数(NAPSI;评分范围 0-8)的平均改善。

结果

72 例患者接受了 1 次或多次依那西普治疗(38 例 BIW/QW;34 例 QW/QW),69 例患者被纳入改良意向治疗人群。基线时,BIW/QW 组和 QW/QW 组目标指甲 NAPSI 评分的平均值(标准误差)分别为 6.0(0.3)和 5.8(0.3)。第 24 周时,BIW/QW 组和 QW/QW 组目标指甲 NAPSI 评分分别显著下降了-4.3[95%置信区间(CI)-4.9 至-3.7;P<0.0001]和-4.4(95%CI-5.0 至-3.7;P<0.0001)。NAPSI 的改善与银屑病面积和严重程度指数的改善呈显著相关性。依那西普治疗具有良好的耐受性,未发现意外的安全性问题。

结论

这两种依那西普方案均能有效治疗该患者人群的指甲银屑病。

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