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

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.

journal_name

Chin Med J (Engl)

journal_title

Chinese medical journal

authors

Cai L,Zhang JZ,Yao X,Gu J,Liu QZ,Zheng M,Zhang SF,Xu JH,Li CX,Cheng H,Guo Q,Pan WL,Li SQ,Li RY,Guo ZP,Song ZQ,Li SS,Dong XQ,Wang L,Fu R,Regnault P,Charef P,Mazur R,Patekar M

doi

10.1097/CM9.0000000000001163

subject

Has Abstract

pub_date

2020-11-20 00:00:00

pages

2665-2673

issue

22

eissn

0366-6999

issn

2542-5641

pii

00029330-202011200-00005

journal_volume

133

pub_type

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