Supplementary Material for: Characterization of Patients with Psoriasis in Challenging-to-Treat Body Areas in the Corrona Psoriasis Registry

Background: Real-world studies evaluating patients with challenging-to-treat localizations of psoriasis (scalp, nail, and palmoplantar) are limited. Objective: To characterize patients with versus without psoriasis in challenging-to-treat areas seen in routine US clinical practice. Methods: This retrospective observational study included all adult patients with psoriasis enrolled in the Corrona Psoriasis Registry between April 2015 and May 2018 who initiated a biologic therapy at registry enrollment. Patients were stratified by the presence of scalp, nail, or palmoplantar psoriasis (nonmutually exclusive groups). Patient demographics, clinical characteristics, disease activity, and patient-reported outcome measures (pain, fatigue, itch, EuroQol visual analog scale [EQ VAS], Dermatology Life Quality Index [DLQI], and Work Productivity and Activity Impairment questionnaire [WPAI]) were assessed at registry enrollment and compared between patients with versus without each challenging-to-treat area using nonparametric Kruskal-Wallis tests for continuous variables and χ2 or Fisher exact tests for categorical variables. Generalized linear regression models were used to estimate differences in disease activity and patient-reported outcomes between patients with versus without each challenging-to-treat area. Results: Among 2,042 patients with psoriasis (mean age [±SD], 49.6 ± 14.7 years; 51.5% male), 38.4% had psoriatic arthritis (PsA), 38.1% had scalp psoriasis, 16.0% had nail psoriasis, 10.9% had palmoplantar psoriasis, and 26.2% had a combination of ≥2 challenging-to-treat areas and PsA; only 34.2% had body plaque psoriasis without PsA or challenging-to-treat areas. Patients in all challenging-to-treat groups reported higher (mean [95% CI]) itch (scalp, 58.01 [57.62–58.40] vs. 54.35 [53.99–54.72]; nail, 56.42 [56.02–56.81] vs. 55.59 [55.20–55.97]; palmoplantar, 60.22 [59.86–60.59] vs. 55.15 [54.79–55.54]) and lower EQ VAS (scalp, 68.12 [67.78–68.48] vs. 69.46 [69.12–69.81]; nail, 66.21 [65.89–66.55] vs. 69.48 [69.14–69.83]; palmoplantar, 66.21 [66.07–66.75] vs. 69.29 [68.94–69.94]) scores than those without the respective challenging-to-treat localization. Patients with nail or palmoplantar psoriasis reported higher pain, fatigue, and DLQI scores than those without. Higher proportions of patients with scalp or palmoplantar psoriasis reported work impairment compared with those without. Conclusion: Two-thirds of patients with psoriasis who initiated biologic therapy had PsA and/or ≥1 challenging-to-treat area. Patients with challenging-to-treat areas had worse patient-reported outcome scores than those without, indicating a significant burden of challenging-to-treat areas on patients’ quality of life.

研究背景：针对银屑病（psoriasis）难治部位（头皮、指甲及掌跖部位）患者的真实世界研究（real-world study）较为匮乏。研究目的：旨在明确美国常规临床实践中，存在难治部位银屑病与无该类部位受累的银屑病患者的临床特征差异。研究方法：本回顾性观察研究纳入了2015年4月至2018年5月期间，在Corrona银屑病登记研究（Corrona Psoriasis Registry）中登记的、入组时即启动生物制剂疗法（biologic therapy）的成年银屑病患者。按照是否存在头皮、指甲或掌跖部位银屑病对患者进行分层（各组并非互斥）。于登记入组时采集患者的人口学特征、临床特征、疾病活动度及患者报告结局指标，包括疼痛、疲劳、瘙痒、EuroQol视觉模拟量表（EQ VAS）、皮肤病生活质量指数（DLQI）以及工作效率与活动受损问卷（WPAI）；针对每个难治部位受累与未受累的患者，采用非参数Kruskal-Wallis检验比较连续变量，采用χ²检验或Fisher精确检验比较分类变量。采用广义线性回归模型，估算每个难治部位受累与未受累患者之间的疾病活动度及患者报告结局指标差异。研究结果：本研究共纳入2042例银屑病患者，平均年龄（±标准差）为49.6±14.7岁，男性占比51.5%；其中38.4%合并银屑病关节炎（PsA），38.1%存在头皮银屑病，16.0%存在指甲银屑病，10.9%存在掌跖部位银屑病，26.2%同时合并≥2个难治部位受累及银屑病关节炎；仅34.2%患者仅表现为身体部位斑块状银屑病，未合并银屑病关节炎及其他难治部位受累。所有难治部位受累组患者的瘙痒评分（均值[95%置信区间]）均高于未受累组：头皮受累组为58.01（57.62~58.40） vs. 未受累组54.35（53.99~54.72）；指甲受累组为56.42（56.02~56.81） vs. 未受累组55.59（55.20~55.97）；掌跖受累组为60.22（59.86~60.59） vs. 未受累组55.15（54.79~55.54）；同时其EuroQol视觉模拟量表评分均低于未受累组：头皮受累组为68.12（67.78~68.48） vs. 未受累组69.46（69.12~69.81）；指甲受累组为66.21（65.89~66.55） vs. 未受累组69.48（69.14~69.83）；掌跖受累组为66.21（66.07~66.75） vs. 未受累组69.29（68.94~69.94）。合并指甲或掌跖部位银屑病的患者，其疼痛、疲劳评分及皮肤病生活质量指数（DLQI）得分均高于未受累患者。头皮或掌跖部位受累的患者中，报告存在工作能力受损的比例更高。研究结论：在启动生物制剂疗法的银屑病患者中，三分之二合并银屑病关节炎及/或至少1个难治部位受累；存在难治部位受累的患者，其患者报告结局指标得分更差，提示难治部位受累对患者的生活质量存在显著负面影响。