Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA.
Eli Lilly and Company, Indianapolis, Indiana, USA.
J Invest Dermatol. 2018 Sep;138(9):1955-1961. doi: 10.1016/j.jid.2018.01.041. Epub 2018 Mar 22.
Clinical outcome measures are becoming more important in psoriasis treatment. Reliable and standardized measures of severity feasible for clinical practice are needed. Our objective was to investigate body surface area (BSA) and the product of BSA and static Physician Global Assessment (sPGA) (ie, BSA × sPGA) as potential proxy measures for PASI scores. Data were pooled from three multicenter, randomized, double-blind, placebo-controlled, phase 3 trials of ixekizumab in patients with moderate to severe psoriasis (UNCOVER-1, -2, -3; N = 3,866). Assessments included the Psoriasis Area and Severity Index (PASI), BSA, and BSA × sPGA. Rank correlations between BSA × sPGA and PASI were stronger than between BSA and PASI (baseline, r = 0.759 vs. r = 0.707; week 12, r = 0.959 vs. r = 0.924). Week 12 concordance rates with PASI responses were as follows: for 75% reduction in PASI: BSA, 86.2%; BSA × sPGA, 93.8%; for 90% reduction in PASI: BSA, 86.9%; BSA × sPGA, 88.2%. The 75% reduction in PASI positive and negative predictive values were higher for BSA × sPGA versus BSA; for 90% reduction in PASI, positive predictive value was lower and negative predictive value was higher for BSA × sPGA versus BSA. Receiver operating characteristic curve analyses identified the most accurate percentage changes in BSA and BSA × sPGA as 66% and 83% for a 75% reduction in PASI cutoff and 84% and 94% for a 90% reduction in PASI, respectively. These results suggest that BSA and BSA × sPGA are viable tools for use as a PASI proxy by real-world practitioners and may be appropriate measurements for use in clinical practice for treat-to-target strategies.
在银屑病治疗中，临床结局指标变得越来越重要。需要可靠且标准化的严重程度衡量指标，这些指标在临床实践中是可行的。我们的目的是研究体表面积（BSA）和 BSA 与静态医师总体评估（sPGA）的乘积（即 BSA×sPGA）是否可以作为 PASI 评分的替代指标。数据来自三项多中心、随机、双盲、安慰剂对照的 3 期 ixekizumab 治疗中重度银屑病的临床试验（UNCOVER-1、-2、-3；N=3866）。评估包括银屑病面积和严重程度指数（PASI）、BSA 和 BSA×sPGA。BSA×sPGA 与 PASI 之间的秩相关关系强于 BSA 与 PASI 之间的秩相关关系（基线，r=0.759 比 r=0.707；第 12 周，r=0.959 比 r=0.924）。第 12 周与 PASI 反应的一致性率如下：对于 PASI 减少 75%：BSA，86.2%；BSA×sPGA，93.8%；对于 PASI 减少 90%：BSA，86.9%；BSA×sPGA，88.2%。BSA×sPGA 预测 PASI 阳性和阴性的准确率高于 BSA；对于 PASI 减少 90%，BSA×sPGA 的阳性预测值低于 BSA，阴性预测值高于 BSA。受试者工作特征曲线分析确定了最准确的 BSA 和 BSA×sPGA 百分比变化，对于 PASI 减少 75%的截断值，分别为 66%和 83%；对于 PASI 减少 90%，分别为 84%和 94%。这些结果表明，BSA 和 BSA×sPGA 是真实世界医生使用 PASI 替代指标的可行工具，并且可能是治疗目标策略中临床实践的适当测量方法。
