1. Secukinumab demonstrates high efficacy and a favorable safety profile over 52 weeks in Chinese patients with moderate to severe plaque psoriasis
- Author
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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, Jing Ni, and Li-Shao Guo
- Subjects
Moderate to severe ,medicine.medical_specialty ,China ,lcsh:Medicine ,Dermatology ,Placebo ,Antibodies, Monoclonal, Humanized ,Severity of Illness Index ,03 medical and health sciences ,0302 clinical medicine ,Double-Blind Method ,Psoriasis ,Internal medicine ,medicine ,Humans ,Adverse effect ,Plaque psoriasis ,Chinese ,business.industry ,Inflammatory skin disease ,lcsh:R ,PASI ,Antibodies, Monoclonal ,General Medicine ,Original Articles ,medicine.disease ,Clinical trial ,Safety profile ,IL-17 ,Treatment Outcome ,030220 oncology & carcinogenesis ,Secukinumab ,business ,030217 neurology & neurosurgery - 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
- Published
- 2020