背景：在CLEAR研究的第4周和第16周，Secukinumab表现出优于ustekinumab的疗效，具有相当的安全性，在患有中度至重度斑块状银屑病的受试者中。
目的：比较苏金单抗和ustekinumab在52周内的疗效和安全性。
方法：分析来自CLEAR的52周数据，一个随机的，双盲,3b阶段研究。
结果：在676名随机受试者中，在第52周,在银屑病面积和严重程度指数(PASI90)改善≥90%的受试者比例(76%vs61%[P<.0001])中,苏金单抗表现出优于ustekinumab的优势;PASI100应答为46%vs.36%(P=.0103),研究者的透明/几乎透明皮肤的全球评估应答为80%vs.65%(P<.0001)。苏金单抗的受试者报告牛皮癣相关疼痛的减少更大，瘙痒,和缩放，并在所有评估的生活质量测量中取得更大的改善(皮肤病学生活质量指数[DLQI]，EuroQoL5维健康问卷，工作效率和活动障碍问卷-银屑病，和健康评估问卷-残疾指数)。在第52周，72%的受试者接受苏金单抗治疗，59%的受试者接受ustekinumab治疗（P=.0008），报告皮肤病对他们的生活没有影响（DLQI0/1反应）。安全性和耐受性相当。
结论：没有安慰剂组。
结论：在这个头对头，双盲研究,苏金单抗在第52周清除皮肤方面与ustekinumab相比表现出持续优异的疗效，生活质量得到更大的改善，以及有利和可比的安全性。
BACKGROUND: 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.
OBJECTIVE: To compare the efficacy and safety of secukinumab and ustekinumab use over 52 weeks.
METHODS: Analysis of 52-week data from CLEAR, a randomized, double-blind, phase 3b study.
RESULTS: 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.
CONCLUSIONS: There was no placebo arm.
CONCLUSIONS: 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.
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