Secukinumab is superior to ustekinumab in clearing skin of subjects with moderate-to-severe plaque psoriasis up to 1 year: Results from the CLEAR study

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• 作者：Andrew Blauvelt ; MD ; MBA^a ; ^{ablauvelt@oregonmedicalresearch.com} ; Kristian Reich ; MD^b ; Tsen-Fang Tsai ; MD^c ; Stephen Tyring ; MD ; PhD^d ; Francisco Vanaclocha ; MD^e ; Kü ; lli Kingo ; MD ; PhD^f ; Michael Ziv ; MD ; BSc^g ; Andreas Pinter ; MD^h ; Ronald Vender ; MD ; FRCPCⁱ ; Sophie Hugot ; MSc^j ; Ruquan You ; MSc^k ; Marina Milutinovic ; MD^j ; Diamant Thaç ; i ; MD^l
• 关键词：psoriasis ; secukinumab ; ustekinumab ; clinical trial ; Psoriasis Area and Severity Index (PASI) ; efficacy ; safety
• 刊名：Journal of the American Academy of Dermatology
• 出版年：2017
• 出版时间：January 2017
• 年：2017
• 卷：76
• 期：1
• 页码：60-69.e9
• 全文大小：2414 K
• 卷排序：76

文摘

Secukinumab demonstrated superior efficacy to ustekinumab at week 4 and week 16 of the CLEAR study, with comparable safety, in subjects with moderate-to-severe plaque psoriasis.ObjectiveTo compare the efficacy and safety of secukinumab and ustekinumab use over 52 weeks.MethodsAnalysis of 52-week data from CLEAR, a randomized, double-blind, phase 3b study.ResultsAmong 676 randomized subjects, secukinumab demonstrated superiority to ustekinumab at week 52 in the proportion of subjects with ≥90% improvement in Psoriasis Area and Severity Index (PASI 90) (76% vs 61% [P < .0001]); PASI 100 responses were 46% versus 36% (P = .0103) and Investigator's Global Assessment responses of clear/almost clear skin were 80% versus 65% (P < .0001). Subjects on secukinumab reported greater reductions in psoriasis-related pain, itching, and scaling, and greater improvement across all quality-of-life measures evaluated (Dermatology Life Quality Index [DLQI], EuroQoL 5-Dimension Health Questionnaire, Work Productivity and Activity Impairment Questionnaire-Psoriasis, and Health Assessment Questionnaire-Disability Index). At week 52, 72% of subjects on secukinumab versus 59% on ustekinumab (P = .0008) reported no impact of skin disease on their lives (DLQI 0/1 response). Safety and tolerability was comparable.LimitationsThere was no placebo arm.ConclusionIn this head-to-head, double-blind study, secukinumab demonstrated sustained superior efficacy in comparison with ustekinumab in clearing skin through week 52, greater improvement in quality of life, and a favorable and comparable safety profile.