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

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收录情况: ◇ SCIE ◇ 统计源期刊 ◇ CSCD-C ◇ 卓越:领军期刊 ◇ 中华系列

单位: [1]Peking Univ Peoples Hosp, Dept Dermatol, Beijing 100044, Peoples R China [2]Chinese Acad Med Sci & Peking Union Med Coll, Inst Dermatol, Beijing 100730, Peoples R China [3]Changhai Hosp, Dept Dermatol, Shanghai 200433, Peoples R China [4]Tianjin Med Univ, Gen Hosp, Dept Dermatol, Tianjin 300052, Peoples R China [5]Zhejiang Univ, Affiliated Hosp 2, Sch Med, Dept Dermatol, Hangzhou 311215, Zhejiang, Peoples R China [6]Gen Hosp Northern Theater Command, Dept Dermatol, Shenyang 110016, Liaoning, Peoples R China [7]Fudan Univ, Huashan Hosp, Dept Dermatol, Shanghai 200040, Peoples R China [8]Chinese Peoples Liberat Army Gen Hosp, Dept Dermatol & Venereol, Beijing 100853, Peoples R China [9]Zhejiang Univ, Sir Run Run Shaw Hosp, Sch Med, Dept Dermatol, Hangzhou 310016, Zhejiang, Peoples R China [10]Sun Yat Sen Mem Hosp, Dept Dermatol, Guangzhou 510120, Guangdong, Peoples R China [11]Zhejiang Prov Peoples Hosp, Dept Dermatol, Hangzhou 310014, Zhejiang, Peoples R China [12]Huazhong Univ Sci & Technol, Tongji Hosp, Tongji Med Coll, Dept Dermatol, Wuhan 430030, Hubei, Peoples R China [13]Peking Univ First Hosp, Dept Dermatol, Beijing 100034, Peoples R China [14]Sichuan Univ, West China Hosp, Dept Dermatol, Chengdu 610041, Sichuan, Peoples R China [15]Dalian Med Univ, Affiliated Hosp 1, Dept Dermatol, Dalian 116011, Liaoning, Peoples R China [16]First Hosp Jilin Univ, Dept Dermatol, Changchun 130021, Jilin, Peoples R China [17]Guangdong Gen Hosp, Dept Dermatol, Guangzhou 510080, Guangdong, Peoples R China [18]Beijing Novartis Pharma Co Ltd, Shanghai 201203, Peoples R China [19]Novartis Pharma AG, CH-6463 Basel, Switzerland
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关键词: Chinese Psoriasis IL-17 Dermatology Clinical trial PASI

摘要:
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.

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出版当年[2019]版:
大类 | 3 区 医学
小类 | 3 区 医学:内科
最新[2025]版:
大类 | 2 区 医学
小类 | 2 区 医学:内科
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出版当年[2018]版:
Q3 MEDICINE, GENERAL & INTERNAL
最新[2023]版:
Q1 MEDICINE, GENERAL & INTERNAL

影响因子: 最新[2023版] 最新五年平均 出版当年[2018版] 出版当年五年平均 出版前一年[2017版] 出版后一年[2019版]

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第一作者单位: [1]Peking Univ Peoples Hosp, Dept Dermatol, Beijing 100044, Peoples R China
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