古塞库单抗:用于治疗中度至重度银屑病的抗白细胞介素-23人源单克隆抗体。
Guselkumab: human monoclonal antibody against interleukin-23 for moderate to severe psoriasis.
作者信息
Paton D M
机构信息
Professor Emeritus of Pharmacology, University of Auckland, Auckland, New Zealand.
出版信息
Drugs Today (Barc). 2018 Mar;54(3):199-207. doi: 10.1358/dot.2018.54.3.2795155.
Guselkumab is an antibody designed to bind to the p19 subunit of interleukin-23 (IL-23). Detailed studies of affected skin in patients with psoriasis demonstrated that guselkumab induced significant changes in the cellular, cytokine and gene expression profiles of psoriatic lesions accompanied by significant changes in clinical measures of disease activity. The significant clinical response in psoriasis was demonstrated in these studies by significant improvement as reflected in the percentage of patients achieving a Physicians Global Assessment score of 0 or 1, and a 90% or 100% improvement in the Psoriasis Area and Severity Index (PASI 90, PASI 100), as well as changes in quality of life measures. These changes were accompanied by a low frequency of adverse effects. The combination of efficacy and safety led to its approval by the Food and Drug Administration (FDA) for use in patients with moderate to severe psoriasis.
古塞库单抗是一种旨在结合白细胞介素-23(IL-23)p19亚基的抗体。对银屑病患者受累皮肤的详细研究表明,古塞库单抗可引起银屑病皮损的细胞、细胞因子和基因表达谱发生显著变化,同时疾病活动的临床指标也有显著改变。这些研究通过显著改善证明了其对银屑病的显著临床疗效,具体表现为达到医师整体评估(PGA)得分为0或1的患者百分比、银屑病面积和严重程度指数(PASI 90、PASI 100)改善90%或100%,以及生活质量指标的变化。这些变化伴随着不良反应的低发生率。疗效和安全性的结合使其获得美国食品药品监督管理局(FDA)批准用于中度至重度银屑病患者。