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

Lin Cai; Jian-zhong Zhang; Xu Yao; Jun GU; Quan-zhong Liu; Min Zheng; Shi-fa Zhang; Jin-hua XU; Cheng-xin LI; Hao Cheng; Qing Guo; Wei-li Pan; Shen-qiu LI; Ruo-yu LI; Zai-pei Guo; Zhi-qi Song; Shan-shan LI; Xiu-qin Dong; Linda Wang; Rong FU; Pascaline Regnault; Pascal Charef; Rafal Mazur; Manmath Patekar

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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.

VernacularTitle:Secukinumab demonstrates high efficacy and a favorable safety profile over 52 weeks in Chinese patients with moderate to severe plaque psoriasis
Author: Lin CAI ¹ ; Jian-Zhong ZHANG ¹ ; Xu YAO ² ; Jun GU ³ ; Quan-Zhong LIU ⁴ ; Min ZHENG ⁵ ; Shi-Fa ZHANG ⁶ ; Jin-Hua XU ⁷ ; Cheng-Xin LI ⁸ ; Hao CHENG ⁹ ; Qing GUO ¹⁰ ; Wei-Li PAN ¹¹ ; Shen-Qiu LI ¹² ; Ruo-Yu LI ¹³ ; Zai-Pei GUO ¹⁴ ; Zhi-Qi SONG ¹⁵ ; Shan-Shan LI ¹⁶ ; Xiu-Qin DONG ¹⁷ ; Linda WANG ¹⁸ ; Rong FU ¹⁸ ; Pascaline REGNAULT ¹⁹ ; Pascal CHAREF ¹⁹ ; Rafal MAZUR ¹⁹ ; Manmath PATEKAR ¹⁹
Author Information

1. Department of Dermatology, Peking University People's Hospital, Beijing 100044, China.
2. Institute of Dermatology, Chinese Academy of Medical Science & Peking Union Medical College, Beijing 100730, China.
3. Department of Dermatology, Changhai Hospital, Shanghai 200433, China.
4. Department of Dermatology, Tianjin Medical University General Hospital, Tianjin 300052, China.
5. Department of Dermatology, Second Affiliated Hospital School of Medicine, Zhejiang University, Hangzhou, Zhejiang 311215, China.
6. Department of Dermatology, General Hospital of Northern Theater Command, Shenyang, Liaoning 110016, China.
7. Department of Dermatology, Huashan Hospital, Fudan University, Shanghai 200040, China.
8. Department of Dermatology and Venereology, Chinese People's Liberation Army General Hospital, Beijing 100853, China.
9. Department of Dermatology, Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang 310016, China.
10. Department of Dermatology, Sun Yat-Sen Memorial Hospital, Guangzhou, Guangdong 510120, China.
11. Department of Dermatology, Zhejiang Provincial People's Hospital, Zhejiang, Hangzhou, Zhejiang 310014, China.
12. Department of Dermatology, Tongji Hospital, Tongji Medical College of Huazhong University of Science & Technology, Wuhan, Hubei 430030, China.
13. Department of Dermatology, Peking University First Hospital, Beijing 100034, China.
14. Department of Dermatology, West China Hospital, Sichuan University, Chengdu, Sichuan 610041, China.
15. Department of Dermatology, First Affiliated Hospital of Dalian Medical University, Dalian, Liaoning 116011, China.
16. Department of Dermatology, The First Hospital of Jilin University, Changchun, Jilin 130021, China.
17. Department of Dermatology, Guangdong General Hospital, Guangzhou, Guangdong 510080, China.
18. Beijing Novartis Pharma Co. Ltd., Shanghai 201203, China.
19. Novartis Pharma AG, Basel 6463, Switzerland.
Publication Type:Randomized Controlled Trial
MeSH: Antibodies, Monoclonal/therapeutic use*; Antibodies, Monoclonal, Humanized; China; Double-Blind Method; Humans; Psoriasis/drug therapy*; Severity of Illness Index; Treatment Outcome
From: Chinese Medical Journal 2020;133(22):2665-2673
CountryChina
Language:English
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.