1.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
Chinese Medical Journal 2020;133(22):2665-2673
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.
Antibodies, Monoclonal/therapeutic use*
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Antibodies, Monoclonal, Humanized
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China
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Double-Blind Method
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Humans
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Psoriasis/drug therapy*
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Severity of Illness Index
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Treatment Outcome
Result Analysis
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