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台湾中重度斑块状银屑病患者使用司库奇尤单抗的疗效和安全性:来自 ERASURE III 期研究的亚分析。

Efficacy and safety of secukinumab in Taiwanese patients with moderate to severe plaque psoriasis: Subanalysis from ERASURE phase III study.

机构信息

Department of Medicine, Mackay Medical College, New Taipei City, Taiwan.

Department of Dermatology, MacKay Memorial Hospital, Taipei, Taiwan.

出版信息

J Dermatol. 2017 Oct;44(10):1129-1137. doi: 10.1111/1346-8138.13900. Epub 2017 May 11.

Abstract

The efficacy and safety of secukinumab, a fully human anti-interleukin-17A monoclonal antibody, has been evaluated for moderate to severe plaque psoriasis in global trials which have included a low proportion of Asian subjects. We analyzed the efficacy and safety of secukinumab in Taiwanese patients in a phase III global clinical trial (ERASURE). Fifty-one Taiwanese patients were randomized into s.c. placebo, 150 and 300 mg secukinumab treatment groups. The proportions of patients who achieved 75% or more improvement in Psoriasis Area and Severity Index (PASI-75) at week 12 were 87.5% with 300 mg secukinumab, 70% with 150 mg secukinumab, 0% with placebo. Of the patients receiving 300 mg secukinumab, 68.8% achieved PASI-90 at week 12. Analysis of overall patients receiving 300 mg secukinumab for 12 weeks showed that the proportion of PASI-75 responders was less in patients with body mass index of 25 or more than less than 25. During the entire 52 weeks, the incidence of adverse events (AE) was consistent with the overall population in ERASURE. The most common AE (cases/per 100 patient-year) during the entire treatment period were upper respiratory tract infection and pruritus. The duration of upper respiratory tract infection per 100 patient-year was approximately 399 days in placebo, 1261 days in 150 mg secukinumab and 1805 days in 300 mg secukinumab. The safety and efficacy of secukinumab in Taiwanese patients was compatible with the global phase III study in the treatment of moderate to severe plaque psoriasis.

摘要

司库奇尤单抗,一种全人源抗白细胞介素-17A 单克隆抗体,在包括少数亚洲受试者的全球试验中已被评估用于中重度斑块状银屑病的疗效和安全性。我们分析了司库奇尤单抗在台湾患者中的疗效和安全性,该研究是一项全球性的 III 期临床试验(ERASURE)。51 例台湾患者被随机分为皮下安慰剂、150mg 和 300mg 司库奇尤单抗治疗组。在第 12 周,300mg 司库奇尤单抗组有 87.5%的患者达到了银屑病面积和严重程度指数(PASI)75%或更高的改善,150mg 司库奇尤单抗组有 70%的患者达到了这一标准,而安慰剂组则没有。在接受 300mg 司库奇尤单抗治疗的患者中,有 68.8%的患者在第 12 周达到了 PASI-90。对接受 300mg 司库奇尤单抗治疗 12 周的所有患者进行分析显示,体重指数为 25 或以上的患者中 PASI-75 应答者的比例较低。在整个 52 周期间,不良反应(AE)的发生率与 ERASURE 中的总体人群一致。在整个治疗期间,最常见的 AE(每 100 患者-年病例数)是上呼吸道感染和瘙痒。在安慰剂组中,上呼吸道感染的年发生率约为 399 例/100 患者-年,150mg 司库奇尤单抗组为 1261 例/100 患者-年,300mg 司库奇尤单抗组为 1805 例/100 患者-年。司库奇尤单抗在台湾患者中的疗效和安全性与全球 III 期研究中治疗中重度斑块状银屑病的结果一致。

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