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

被引:50
作者
Cai Lin [1 ,2 ,3 ,4 ]
Zhang JianZhong
Yao Xu [5 ,6 ,7 ,4 ]
Gu Jun [1 ,8 ,9 ,4 ]
Liu QuanZhong [1 ,10 ,11 ,4 ]
Zheng Min [1 ,12 ,13 ,14 ,15 ,4 ]
Zhang ShiFa [1 ,16 ,17 ,18 ,4 ]
Xu JinHua [1 ,19 ,20 ,21 ,4 ]
Li ChengXin [22 ,23 ,24 ,4 ]
Cheng Hao [1 ,25 ,26 ,14 ,27 ,4 ]
Guo Qing [1 ,28 ,29 ,30 ,4 ]
Pan WeiLi [1 ,31 ,32 ,14 ,33 ,4 ]
Li ShenQiu [1 ,34 ,35 ,36 ,37 ,4 ]
Li RuoYu [1 ,38 ,39 ,4 ]
Guo ZaiPei [1 ,40 ,41 ,42 ,43 ,4 ]
Song ZhiQi [1 ,44 ,45 ,46 ,4 ]
Li ShanShan [1 ,47 ,48 ,49 ,4 ]
Dong XiuQin [1 ,50 ,29 ,51 ,4 ]
Wang Linda [52 ,53 ,4 ]
Fu Rong [52 ,53 ,4 ]
Regnault Pascaline [54 ,55 ,56 ]
Charef Pascal [54 ,55 ,56 ]
Mazur Rafal [54 ,55 ,56 ]
Patekar Manmath [54 ,55 ,56 ]
机构
[1] Department of Dermatology
[2] Peking University People’s Hospital
[3] Beijing
[4] China
[5] Institute of Dermatology
[6] Chinese Academy of Medical Science & Peking Union Medical College
[7] Changhai Hospital
[8] Shanghai
[9] Tianjin Medical University General Hospital
[10] Tianjin
[11] Second Affiliated Hospital School of Medicine
[12] Zhejiang University
[13] Hangzhou
[14] Zhejiang
[15] General Hospital of Northern Theater Command
[16] Shenyang
[17] Liaoning
[18] Huashan Hospital
[19] Fudan University
[20] Department of Dermatology and Venereology
[21] Chinese People’s Liberation Army General Hospital
[22] Sir Run Run Shaw Hospital
[23] Zhejiang University School of Medicine
[24] Sun Yat-Sen Memorial Hospital
[25] Guangzhou
[26] Guangdong
[27] Zhejiang Provincial People’s Hospital
[28] Tongji Hospital
[29] Tongji Medical College of Huazhong University of Science & Technology
[30] Wuhan
[31] Hubei
[32] Peking University First Hospital
[33] West China Hospital
[34] Sichuan University
[35] Chengdu
[36] Sichuan
[37] First Affiliated Hospital of Dalian Medical University
[38] Dalian
[39] The First Hospital of Jilin University
[40] Changchun
[41] Jilin
[42] Guangdong General Hospital
[43] Beijing Novartis Pharma Co Ltd
[44] Novartis Pharma AG
[45] Basel
[46] Switzerland
关键词
Chinese; Psoriasis; IL-17; Dermatology; Clinical trial; PASI;
D O I
暂无
中图分类号
R758.63 [牛皮癣(银屑病)];
学科分类号
100227 [皮肤病学];
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.Trial Registration: ClinicalTrials.gov, NCT03066609; https://clinicaltrials.gov/ct2/show/record/NCT03066609.
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