Ixekizumab 在中国中重度斑块型银屑病成人患者中的安全性和疗效：一项前瞻性、多中心、观察性研究。
Safety and Efficacy of Ixekizumab in Chinese Adults with Moderate-to-Severe Plaque Psoriasis: A Prospective, Multicenter, Observational Study.
机构信息
Department of Dermatology, Shanghai Skin Disease Hospital, Tongji University School of Medicine, Shanghai, 200443, China.
Department of Dermatology, Dermatology Hospital, Southern Medical University, Guangzhou, China.
出版信息
Adv Ther. 2023 Dec;40(12):5464-5474. doi: 10.1007/s12325-023-02672-1. Epub 2023 Oct 12.
INTRODUCTION
Psoriasis, an incurable chronic inflammatory disease, affects over 6 million people in China. Ixekizumab, a monoclonal antibody against interleukin-17A, has demonstrated efficacy and safety for the treatment of moderate-to-severe plaque psoriasis, although limited data are available regarding its use in routine clinical practice in China. We investigated the real-world application of ixekizumab in China.
METHODS
Adults (≥ 18 years) with moderate-to-severe plaque psoriasis prescribed ixekizumab in routine clinical practice were enrolled in this prospective, observational, single-arm, multicenter, post-marketing surveillance study. The primary endpoint was the safety of ixekizumab at week 12. The effectiveness of ixekizumab, based on the Psoriasis Area and Severity Index (PASI) and Dermatology Life Quality Index (DLQI), was assessed as a secondary endpoint.
RESULTS
In total, 666 patients were enrolled; 663 were included in the safety analysis, and 612 in the effectiveness analysis. At least one adverse event (AE) was reported by 42.7% (283/663) of patients, most of which were mild (242/283, 85.5%), and 32.7% (217/663) of patients reported AEs related to study treatment. The most frequently reported AEs were injection site reactions. AEs led to discontinuation in five patients (0.8%). Only three patients had a serious AE. Mean ± standard deviation (SD) change from baseline in PASI score was reduction in 10.79 ± 9.55 at week 2 and 16.80 ± 12.15 at week 12. At week 2, 63.7% of patients achieved PASI 50. At week 12, 93.2%, 77.4%, and 45.1% of patients achieved PASI 75, PASI 90, and PASI 100, respectively. Mean ± SD change from baseline in DLQI was reduction in 5.91 ± 6.27 at week 2 and 9.76 ± 7.16 at week 12. DLQI 0/1 was achieved by 19.8% and 59.9% of patients at week 2 and 12, respectively.
CONCLUSION
Ixekizumab was well tolerated and effective in real-world clinical practice in Chinese adults with moderate-to-severe plaque psoriasis.
简介
银屑病是一种无法治愈的慢性炎症性疾病，影响了中国超过 600 万人。依奇珠单抗是一种针对白细胞介素-17A 的单克隆抗体，已被证明对中重度斑块状银屑病的治疗有效且安全，尽管在中国常规临床实践中使用的相关数据有限。我们研究了依奇珠单抗在中国的真实世界应用。
方法
本前瞻性、观察性、单臂、多中心、上市后监测研究纳入了在常规临床实践中接受依奇珠单抗治疗的中重度斑块状银屑病成年患者（≥18 岁）。主要终点为第 12 周时依奇珠单抗的安全性。次要终点为基于银屑病面积和严重程度指数（PASI）和皮肤病生活质量指数（DLQI）评估的依奇珠单抗有效性。
结果
共纳入 666 例患者；663 例患者纳入安全性分析，612 例患者纳入有效性分析。42.7%（283/663）的患者报告至少发生 1 次不良事件（AE），大多数为轻度（242/283，85.5%），32.7%（217/663）的患者报告与研究治疗相关的 AE。最常报告的 AE 为注射部位反应。5 例患者（0.8%）因 AE 而停药。仅有 3 例患者发生严重 AE。基线时 PASI 评分的平均±标准差（SD）变化在第 2 周为减少 10.79±9.55，第 12 周为减少 16.80±12.15。第 2 周时，63.7%的患者达到 PASI 50。第 12 周时，93.2%、77.4%和 45.1%的患者分别达到 PASI 75、PASI 90 和 PASI 100。基线时 DLQI 的平均±SD 变化在第 2 周为减少 5.91±6.27，第 12 周为减少 9.76±7.16。第 2 周和第 12 周时，19.8%和 59.9%的患者达到 DLQI 0/1。
结论
在中重度斑块状银屑病中国成年患者的真实世界临床实践中，依奇珠单抗耐受良好且有效。
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