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

• Published in: Journal of the American Academy of Dermatology Vol. 76; no. 1; pp. 60 - 69.e9
• Main Authors: Blauvelt, Andrew, Reich, Kristian, Tsai, Tsen-Fang, Tyring, Stephen, Vanaclocha, Francisco, Kingo, Külli, Ziv, Michael, Pinter, Andreas, Vender, Ronald, Hugot, Sophie, You, Ruquan, Milutinovic, Marina, Thaçi, Diamant
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01.01.2017
• Subjects: Adult; Antibodies, Monoclonal - adverse effects; Antibodies, Monoclonal - therapeutic use; clinical trial; Dermatologic Agents - adverse effects; Dermatologic Agents - therapeutic use; Dermatology; Double-Blind Method; efficacy; Female; Humans; Male; Middle Aged; psoriasis; Psoriasis - drug therapy; Psoriasis Area and Severity Index (PASI); safety; secukinumab; Severity of Illness Index; Treatment Outcome; ustekinumab; Ustekinumab - adverse effects; Ustekinumab - therapeutic use; clinical trial; DLQI; PASI 90; PASI; IL; AE; NRI; IGA mod 2011; secukinumab; PASI 75; EQ-5D-3L; HAQ-DI; Psoriasis Area and Severity Index (PASI); efficacy; PASI 100; ustekinumab; psoriasis; safety; HRQOL; MI; WPAI-PSO; PsA; 100% improvement from baseline Psoriasis Area and Severity Index; multiple imputation; Psoriasis Area and Severity Index; 90% or more improvement from baseline Psoriasis Area and Severity Index; interleukin; Work Productivity and Activity Impairment Questionnaire-Psoriasis; nonresponder imputation; EuroQoL 5-Dimension Health Questionnaire 3-level version; adverse event; health-related quality of life; 75% or more improvement from baseline Psoriasis Area and Severity Index; Dermatology Life Quality Index; Health Assessment Questionnaire-Disability Index; Investigator's Global Assessment, 2011 modified version; psoriatic arthritis
• ISSN: 0190-9622; 1097-6787
• DOI: 10.1016/j.jaad.2016.08.008

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. To compare the efficacy and safety of secukinumab and ustekinumab use over 52 weeks. Analysis of 52-week data from CLEAR, a randomized, double-blind, phase 3b study. Among 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. There was no placebo arm. In 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.