The UTHealth McGovern Medical School, Houston, Texas, USA.
CWRU Schools of Medicine and Nursing, Case Western Reserve University Cleveland, Cleveland, Ohio, USA.
Pediatr Dermatol. 2022 Jan;39(1):55-60. doi: 10.1111/pde.14892. Epub 2021 Dec 20.
BACKGROUND/OBJECTIVES: Information is limited on the relationship between skin clearance, resolution of challenging body areas, and improvement of patient-reported outcomes (PROs) in pediatric psoriasis. Ixekizumab, a high-affinity monoclonal antibody that selectively targets interleukin-17A, is approved for the treatment of moderate-to-severe psoriasis in patients aged 6 to <18 years. This study examines improvement in psoriasis clearance in challenging body areas in pediatric patients relative to health-related quality of life.
Data from the IXORA-PEDS trial (NCT03073200) were analyzed, and changes from baseline were measured for overall Psoriasis Area and Severity Index (PASI), static Physicians' Global Assessment of psoriasis (sPGA), Psoriasis Scalp Severity Index (PSSI), Palmoplantar Psoriasis Area and Severity Index (PPASI), and Nail Psoriasis Severity Index. Rates of Dermatology Life Quality Index (DLQI), or Children's DLQI (CDLQI), scores of 0 or 1 were evaluated using the Cochran-Armitage trend test.
Higher rates of DLQI/CDLQI (0,1) scores were significantly associated with greater PASI and PSSI responses at both Week 12 and Week 48 (p < .0001). A significant association was also observed between DLQI/CDLQI (0,1) and sPGA scores (p < .0001). Significantly higher rates of DLQI/CDLQI (0,1) scores were achieved in patients with greater levels of palmoplantar clearance as measured by PPASI at Week 12 (p = .0139), but significance was not sustained at Week 48 (p = .0896).
Greater skin clearance and scalp resolution are associated with better PROs over a short-term (12-week) and long-term (48-week) period. This demonstrates that greater improvement of skin clearance and scalp resolution may benefit quality of life in pediatric patients with psoriasis.
背景/目的:关于皮肤清除率、挑战性身体部位的缓解情况与患者报告结局(PRO)改善之间的关系,信息有限。依奇珠单抗是一种高亲和力的单克隆抗体,可选择性靶向白细胞介素-17A,批准用于治疗 6 至<18 岁中重度银屑病患者。本研究检测了在儿童银屑病患者中,与健康相关的生活质量相比,挑战性身体部位的银屑病清除率改善情况。
对 IXORA-PEDS 试验(NCT03073200)的数据进行了分析,从基线开始测量整体银屑病面积和严重程度指数(PASI)、静态医师整体评估(sPGA)、头皮银屑病严重程度指数(PSSI)、手掌和足底银屑病面积和严重程度指数(PPASI)、指甲银屑病严重程度指数的变化。使用 Cochran-Armitage 趋势检验评估皮肤病生活质量指数(DLQI)或儿童皮肤病生活质量指数(CDLQI)评分 0 或 1 的比例。
更高的 DLQI/CDLQI(0,1)评分与第 12 周和第 48 周时 PASI 和 PSSI 反应更高显著相关(p<0.0001)。DLQI/CDLQI(0,1)与 sPGA 评分之间也存在显著相关性(p<0.0001)。在第 12 周时,PPASI 测量的手掌和足底清除率水平较高的患者中,达到 DLQI/CDLQI(0,1)评分的比例显著更高(p=0.0139),但在第 48 周时,这种相关性不再显著(p=0.0896)。
皮肤清除率和头皮缓解程度与短期(12 周)和长期(48 周)的 PRO 改善显著相关。这表明,皮肤清除率和头皮缓解程度的改善可能有益于儿童银屑病患者的生活质量。