{Reference Type}: Clinical Trial, Phase III
{Title}: 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.
{Author}: Blauvelt A;Reich K;Tsai TF;Tyring S;Vanaclocha F;Kingo K;Ziv M;Pinter A;Vender R;Hugot S;You R;Milutinovic M;Thaçi D;
{Journal}: J Am Acad Dermatol
{Volume}: 76
{Issue}: 1
{Year}: Jan 2017
{Factor}: 15.487
{DOI}: 10.1016/j.jaad.2016.08.008
{Abstract}: <B>BACKGROUND: </B>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.<BR><B>OBJECTIVE: </B>To compare the efficacy and safety of secukinumab and ustekinumab use over 52 weeks.<BR><B>METHODS: </B>Analysis of 52-week data from CLEAR, a randomized, double-blind, phase 3b study.<BR><B>RESULTS: </B>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.<BR><B>CONCLUSIONS: </B>There was no placebo arm.<BR><B>CONCLUSIONS: </B>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.