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首页> 外文期刊>Journal of dermatological science >Efficacy and safety of ustekinumab for the treatment of moderate-to-severe psoriasis: a phase III, randomized, placebo-controlled trial in Taiwanese and Korean patients (PEARL).
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Efficacy and safety of ustekinumab for the treatment of moderate-to-severe psoriasis: a phase III, randomized, placebo-controlled trial in Taiwanese and Korean patients (PEARL).

机译：Ustekinumab治疗中度至重度牛皮癣的疗效和安全性：台湾和韩国患者（PEARL）的一项III期，随机，安慰剂对照试验。

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BACKGROUND: Ustekinumab has been evaluated in Caucasian patients with psoriasis, but no studies have been conducted in Asian patients. OBJECTIVE: To assess the efficacy and safety of ustekinumab in Taiwanese and Korean patients with moderate-to-severe psoriasis. METHODS: In this 36-week, multicenter, double-blind, placebo-controlled study, 121 patients with moderate-to-severe psoriasis were randomized (1:1) to receive subcutaneous injections of ustekinumab 45mg at weeks 0, 4, 16 or placebo at weeks 0, 4 and ustekinumab 45mg at weeks 12, 16. Efficacy endpoints at week 12 included the proportion of patients achieving at least 75% improvement from baseline in Psoriasis Area and Severity Index (PASI 75; primary endpoint), proportion of patients with Physician's Global Assessment (PGA) of cleared or minimal, and change from baseline in Dermatology Life Quality Index (DLQI). RESULTS: At week 12, the proportion of patients achieving PASI 75 was 67.2% and 5.0% in the ustekinumab 45mg and placebo groups, respectively (p<0.001). PGA of cleared or minimal was achieved by 70.5% (ustekinumab) and 8.3% (placebo; p<0.001), and median DLQI changes were -11.0 and 0.0, respectively (p<0.001). Efficacy was maintained through week 28 in ustekinumab-treated patients. Adverse event (AE) profiles at week 12 were similar between the ustekinumab and placebo groups: 65.6% and 70.0%, respectively, had at least one reported AE. Through week 36, no disproportionate increase in AEs was observed, with the exception of abnormal hepatic function, which was related to concomitant isoniazid treatment for latent tuberculosis. Injection-site reactions were rare and mild. No deaths, malignancies, or cardiovascular events were reported. CONCLUSIONS: Treatment with subcutaneous ustekinumab 45mg offers a favorable benefit/risk profile for Taiwanese and Korean patients with moderate-to-severe psoriasis. The efficacy and safety profile is consistent with the global phase III studies of ustekinumab in psoriasis.
机译：背景：乌斯他单抗已在白种人牛皮癣患者中进行了评估，但尚未在亚洲患者中进行任何研究。目的：评估ustekinumab在台湾和韩国中度至重度牛皮癣患者中的疗效和安全性。方法：在这项为期36周的多中心，双盲，安慰剂对照研究中，将121例中至重度牛皮癣患者随机（1：1）在第0、4、16或16周接受皮下注射ustekinumab 45mg在第0、4周时使用安慰剂，在第12、16周时使用ustekinumab 45mg，在第12周时的功效终点包括银屑病面积和严重性指数（PASI 75;主要终点）比基线提高至少75％的患者比例，医师的全球评估（PGA）为已清除或极小，并且皮肤病生活质量指数（DLQI）与基线相比有所变化。结果：在第12周，ustekinumab 45mg和安慰剂组分别达到PASI 75的患者比例分别为67.2％和5.0％（p <0.001）。 PGA的清除或极小值分别达到70.5％（ustekinumab）和8.3％（安慰剂; p <0.001），中位数DLQI变化分别为-11.0和0.0（p <0.001）。乌斯他单抗治疗的患者在第28周一直保持疗效。 ustekinumab组和安慰剂组在第12周的不良事件（AE）资料相似：分别有至少一种报告的AE，分别为65.6％和70.0％。到第36周，除肝功能异常外，未观察到AE的不成比例的增加，这与同时用异烟肼治疗潜伏性结核有关。注射部位的反应很少见且轻微。没有死亡，恶性肿瘤或心血管事件的报道。结论：皮下注射乌斯库单抗45mg为台湾和韩国中度至重度牛皮癣患者提供了有利的获益/风险特征。疗效和安全性与乌斯替单抗治疗牛皮癣的全球III期研究一致。

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