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用于比较依奇珠单抗与依那西普和安慰剂在中重度斑块状银屑病患者中的疗效的绝对和相对银屑病面积和严重程度指数(PASI):UNCOVER-2 和 UNCOVER-3 结局的综合分析。

Absolute and Relative Psoriasis Area and Severity Indices (PASI) for Comparison of the Efficacy of Ixekizumab to Etanercept and Placebo in Patients with Moderate-to-severe Plaque Psoriasis: An Integrated Analysis of UNCOVER-2 and UNCOVER-3 Outcomes.

机构信息

Department of Dermatology, Hospital de la Santa Creu i Sant Pau, ES-08026 Barcelona, Spain.

出版信息

Acta Derm Venereol. 2019 Oct 1;99(11):971-977. doi: 10.2340/00015555-3245.

DOI:10.2340/00015555-3245
PMID:31240322
Abstract

Treatment goals defined by the absolute Psoriasis Area and Severity Index (PASI) scores offer certain advantages in the clinical setting. In order to investigate potential treatment targets, this study evaluated absolute PASI outcomes relative to other measures of response using data from two randomized clinical trials of patients with moderate-to-severe psoriasis treated with ixekizumab, etanercept, or placebo (n=2,567). Response was assessed throughout 12 weeks as the proportion of patients achieving absolute PASI band cut-offs who also reached established response criteria. Most PASI band ≤2 responders also achieved PASI 90 (70.1-100%), static Physician's Global Assessment (0,1) (91.3-96.1%), Dermatology Life Quality Index (0,1) (63.0-67.7%), Patient Global Assessment of Disease Severity (0,1) (80.3-86.7%), and Itch Numeric Rating Scale improvement ≥4 (87.2-87.6%). Agreement sharply decreased for less stringent PASI criteria. These data indicate that PASI ≤2 represents significantly meaningful clinical and health-related quality of life improvements and may be a suitable treatment target for moderate-to-severe plaque psoriasis.

摘要

治疗目标由绝对银屑病面积和严重程度指数(PASI)评分定义,在临床环境中具有一定的优势。为了研究潜在的治疗靶点,本研究使用接受依奇珠单抗、依那西普或安慰剂治疗的中重度斑块型银屑病患者的两项随机临床试验数据,评估了绝对 PASI 结果相对于其他反应衡量标准的结果(n=2567)。在 12 周内通过达到绝对 PASI 波段截止值且同时达到既定反应标准的患者比例来评估反应。大多数 PASI 波段≤2 的应答者也达到 PASI 90(70.1-100%)、静态医师总体评估(0,1)(91.3-96.1%)、皮肤病生活质量指数(0,1)(63.0-67.7%)、患者总体疾病严重程度评估(0,1)(80.3-86.7%)和瘙痒数字评分量表改善≥4(87.2-87.6%)。对于不太严格的 PASI 标准,一致性急剧下降。这些数据表明,PASI ≤2 代表着显著的临床和健康相关生活质量改善,可能是中重度斑块型银屑病的合适治疗目标。

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Absolute and Relative Psoriasis Area and Severity Indices (PASI) for Comparison of the Efficacy of Ixekizumab to Etanercept and Placebo in Patients with Moderate-to-severe Plaque Psoriasis: An Integrated Analysis of UNCOVER-2 and UNCOVER-3 Outcomes.用于比较依奇珠单抗与依那西普和安慰剂在中重度斑块状银屑病患者中的疗效的绝对和相对银屑病面积和严重程度指数(PASI):UNCOVER-2 和 UNCOVER-3 结局的综合分析。
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