Secukinumab demonstrates high efficacy and a favorable safety profile over 52 weeks in Chinese patients with moderate to severe plaque psoriasis

塞库金单抗 医学 安慰剂 斑块性银屑病 银屑病 银屑病面积及严重程度指数 皮肤病科 临床终点 随机对照试验 人口 临床试验 不利影响 内科学 病理 替代医学 银屑病性关节炎 环境卫生
作者
Lin Cai,Jianzhong Zhang,Xu Yao,Jun Gu,Quanzhong Liu,Min Zheng,Shifa Zhang,Jinhua Xu,Cheng‐Xin Li,Hao Cheng,Qing Guo,Weili Pan,Shenqiu Li,Ruoyu Li,Zaipei Guo,Zhiqi Song,Shanshan Li,Xiuqin Dong,Linda Wang,Rong Fu,P. Regnault,Pascal Charef,Rafał Mazur,Manmath Patekar
出处
期刊:Chinese Medical Journal [Lippincott Williams & Wilkins]
卷期号:133 (22): 2665-2673 被引量:32
标识
DOI:10.1097/cm9.0000000000001163
摘要

Abstract Background: Psoriasis is a chronic inflammatory skin disease, affecting about 0.6% of the Chinese population. Many patients are not well controlled by conventional treatments, thus there is need for new treatment regimens. In this study, we assessed the efficacy and safety of secukinumab in Chinese patients with moderate to severe plaque psoriasis. Methods: This study was a 52-week, multicentre, randomized, double-blind, placebo-controlled, parallel-group, Phase 3 trial. A sub-population of study participants (≥18 years) of Chinese ethnicity were randomized to receive subcutaneous injections of 300 or 150 mg secukinumab, or placebo. The co-primary endpoints were psoriasis area severity index (PASI) 75 and Investigator's Global Assessment (IGA) 0/1 at Week 12. Results: A total of 441 Chinese patients were enrolled in this study. Co-primary outcomes were achieved; 300 and 150 mg secukinumab were superior to placebo as shown in the proportion of patients that achieved PASI 75 (97.7% and 87.2% vs. 3.7%, respectively; P < 0.001), and IGA 0/1 (82.3% and 69.7% vs. 2.7%; P < 0.001) at Week 12. Treatment efficacy was maintained until Week 52. There was no increase in overall adverse events with secukinumab relative to placebo throughout the 52-week period. Conclusion: Secukinumab is highly effective and well tolerated in Chinese patients with moderate to severe plaque psoriasis. Trial Registration: ClinicalTrials.gov, NCT03066609; https://clinicaltrials.gov/ct2/show/record/NCT03066609.
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