Secukinumab maintains superiority over ustekinumab in clearing skin and improving quality of life in patients with moderate to severe plaque psoriasis: 52-week results from a double-blind phase 3b trial (CLARITY).
Secukinumab maintains superiority over ustekinumab in clearing skin and improving quality of life in patients with moderate to severe plaque psoriasis: 52-week results from a double-blind phase 3b trial (CLARITY).
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DOI：
10.1111/jdv.16558
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发表时间：
2021-01
期刊：
影响因子：
--
通讯作者：
Lebwohl M
中科院分区：
文献类型：
--
作者：
Bagel J;Blauvelt A;Nia J;Hashim P;Patekar M;de Vera A;Ahmad K;Paguet B;Xia S;Muscianisi E;Lebwohl M
Secukinumab在治疗中度至重度斑块状银屑病方面的疗效上级乌司奴单抗，在16周的研究中和52周的CLEAR研究中。比较阿司奴单抗与乌司奴单抗在52周内在Patiity中的疗效和安全性。分析来自CIMITY（NCT 02826603）的52周数据，这是一项3b期研究，患者根据标签随机接受阿司奴单抗300 mg（n = 550）或乌司奴单抗45/90 mg（n = 552）。第52周时，在银屑病面积和严重程度指数改善≥ 90%的患者比例方面，阿基诺单抗优于乌司奴单抗（上级）（73.2%对59.8%;优势比[OR]，1.84 [95%置信区间，1.41-2.41]; P < 0.0001），研究者的总体评估修改了2011年皮肤透明（0）或几乎透明（1）的反应（76.0% vs. 60.2%; OR，2.12 [95% CI，1.61-2.79]; P < 0.0001）和皮肤病生活质量指数反应无影响（0/1）（69.9% vs. 61.2%; P = 0.0028）。治疗组之间发生任何不良事件的患者比例相当。第二项头对头研究证实，在52周内，阿基诺单抗在皮肤清除率和生活质量方面的疗效上级乌司奴单抗，安全性与既往试验报告的结果相当。Clinicaltrials.gov标识符：NCT 02826603。
Secukinumab demonstrated superior efficacy over ustekinumab in the treatment of moderate to severe plaque psoriasis over 16 weeks in the CLARITY study and over 52 weeks in the CLEAR study. To compare the efficacy and safety of secukinumab vs. ustekinumab over 52 weeks in CLARITY. Analysis of 52‐week data from CLARITY (NCT02826603), a phase 3b study in which patients were randomized to receive secukinumab 300 mg (n = 550) or ustekinumab 45/90 mg (n = 552) per label. At week 52, secukinumab was superior to ustekinumab in the proportion of patients who achieved ≥ 90% improvement in Psoriasis Area and Severity Index (73.2% vs. 59.8%; odds ratio [OR], 1.84 [95% CI, 1.41–2.41]; P < 0.0001), Investigator’s Global Assessment modified 2011 responses of clear (0) or almost clear (1) skin (76.0% vs. 60.2%; OR, 2.12 [95% CI, 1.61–2.79]; P < 0.0001) and Dermatology Life Quality Index response of no effect (0/1) (69.9% vs. 61.2%; P = 0.0028). Proportions of patients with any adverse events were comparable between treatment arms. This second head‐to‐head study confirmed the superior efficacy of secukinumab over ustekinumab in skin clearance and quality of life through 52 weeks, with safety comparable to that reported in previous trials. Clinicaltrials.gov identifier: NCT02826603.
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