Department of Dermatology, Beijing Changping Hospital of Traditional Chinese Medicine, Beijing, China.
Department of Dermatology, Tongzhou Branch, Dongzhimen Hospital, Beijing University of Traditional Chinese Medicine, Beijing, China.
Dermatology. 2024;240(2):271-281. doi: 10.1159/000534703. Epub 2023 Nov 3.
Secukinumab, a fully humanized monoclonal antibody against IL-17A, was approved for the treatment of moderate-to-severe plaque psoriasis in the USA and European Union in 2015.
Secukinumab, a fully humanized monoclonal antibody against IL-17A, was approved for the treatment of moderate-to-severe plaque psoriasis in the USA and European Union in 2015. The aim of this study was to systematically evaluate the efficacy and safety of secukinumab for the treatment of moderate and severe plaque psoriasis and provide an evidence-based reference for clinical practice.
PubMed, Google Scholar, Cochrane Library, and Clinical Trials databases were searched. Pivotal phase III clinical trials were analysed. RevMan was used for the statistical analysis of the data.
Seven pivotal phase III clinical trials were analysed. All trials evaluated secukinumab in moderate-to-severe plaque psoriasis and had two common primary end points: the proportion of respondents to the Psoriasis Area and Severity Index (PASI) and the proportion of respondents to the Investigator's Global Assessment (IGA). The total response ratios of PASI and IGA respondents in the secukinumab group were 82.8 and 71.3%, respectively, compared to placebo. Secukinumab was superior to etanercept, with risk ratios of 1.7 and 2.1, respectively. Secukinumab was generally well tolerated during the 1-year trial period. However, adverse events also occurred.
Secukinumab was found to be more effective than etanercept and had an acceptable safety profile. Since psoriasis is an autoimmune disease that requires lifelong treatment, attention should be paid to its adverse effects.
司库奇尤单抗是一种针对白细胞介素 17A 的全人源化单克隆抗体，于 2015 年在美国和欧盟获批用于中重度斑块状银屑病的治疗。
司库奇尤单抗是一种针对白细胞介素 17A 的全人源化单克隆抗体，于 2015 年在美国和欧盟获批用于中重度斑块状银屑病的治疗。本研究旨在系统评价司库奇尤单抗治疗中重度斑块状银屑病的疗效和安全性，为临床实践提供循证参考。
检索PubMed、Google Scholar、Cochrane Library 和临床试验数据库。分析关键的 III 期临床试验。使用 RevMan 对数据进行统计分析。
分析了 7 项关键的 III 期临床试验。所有试验均评估了司库奇尤单抗治疗中重度斑块状银屑病，有两个共同的主要终点：银屑病面积和严重程度指数（PASI）应答者比例和研究者全球评估（IGA）应答者比例。司库奇尤单抗组 PASI 和 IGA 应答者的总应答率分别为 82.8%和 71.3%，高于安慰剂组。司库奇尤单抗优于依那西普，风险比分别为 1.7 和 2.1。在为期 1 年的试验期间，司库奇尤单抗总体耐受性良好。然而，也发生了不良反应。
与依那西普相比，司库奇尤单抗更有效，且安全性特征可接受。由于银屑病是一种需要终身治疗的自身免疫性疾病，应注意其不良反应。
