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

被引:267
作者
Blauvelt, Andrew [1 ]
Reich, Kristian [2 ,3 ]
Tsai, Tsen-Fang [4 ]
Tyring, Stephen [5 ]
Vanaclocha, Francisco [6 ]
Kingo, Kulli [7 ]
Ziv, Michael [8 ]
Pinter, Andreas [9 ]
Vender, Ronald [10 ]
Hugot, Sophie [11 ]
You, Ruquan [12 ]
Milutinovic, Marina [11 ]
Thaci, Diamant [13 ]
机构
[1] Oregon Med Res Ctr, 9495 SW Locust St,Suite G, Portland, OR 97223 USA
[2] Dermatologikum Hamburg, Hamburg, Germany
[3] SCIderm Res Inst, Hamburg, Germany
[4] Natl Taiwan Univ, Coll Med, Natl Taiwan Univ Hosp, Taipei, Taiwan
[5] Univ Texas Hlth Sci Ctr Houston, Ctr Clin Studies, Houston, TX 77030 USA
[6] Hosp Univ 12 Octubre, Madrid, Spain
[7] Tartu Univ Hosp, Dermatol Clin, Tartu, Estonia
[8] Emek Med Ctr, Afula, Israel
[9] Goethe Univ, Frankfurt, Germany
[10] McMaster Univ, Hamilton, ON, Canada
[11] Novartis Pharma AG, Basel, Switzerland
[12] Novartis Beijing Novartis Pharma Co Ltd, Shanghai, Peoples R China
[13] Univ Hosp Schleswig Holstein, Comprehens Ctr Inflammat Med, Lubeck, Germany
关键词
psoriasis; secukinumab; ustekinumab; clinical trial; Psoriasis Area and Severity Index (PASI); efficacy; safety; INTERLEUKIN-12/23; MONOCLONAL-ANTIBODY; CONTROLLED-TRIAL; DOUBLE-BLIND; EFFICACY; SAFETY; USABILITY; ARTHRITIS; FUTURE;
D O I
10.1016/j.jaad.2016.08.008
中图分类号
R75 [皮肤病学与性病学];
学科分类号
100227 [皮肤病学];
摘要
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. Limitations: There was no placebo arm. Conclusion: 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.
引用
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页码:60 / +
页数:19
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