阿柏西普单药治疗对中重度特应性皮炎青少年和成人患者报告症状和生活质量的影响：患者报告结局的汇总分析。
Impact of Oral Abrocitinib Monotherapy on Patient-Reported Symptoms and Quality of Life in Adolescents and Adults with Moderate-to-Severe Atopic Dermatitis: A Pooled Analysis of Patient-Reported Outcomes.
机构信息
The George Washington University School of Medicine and Health Sciences, Washington, DC, USA.
Bispebjerg Hospital, University of Copenhagen, Copenhagen, Denmark.
出版信息
Am J Clin Dermatol. 2021 Jul;22(4):541-554. doi: 10.1007/s40257-021-00604-9. Epub 2021 May 5.
BACKGROUND
Atopic dermatitis imparts a substantial patient burden, including itch, sleep disturbance, and decreased health-related quality of life.
OBJECTIVE
This analysis evaluated changes in patient-reported outcomes of disease-specific signs/symptoms and health-related quality of life in adult and adolescent patients with moderate-to-severe atopic dermatitis treated with once-daily oral abrocitinib 200-mg or 100-mg monotherapy.
METHODS
Pooled data from one phase IIb (NCT02780167) and two phase III (NCT03349060, JADE MONO-1; NCT03575871, JADE MONO-2) monotherapy trials in adult and adolescent patients with moderate-to-severe atopic dermatitis were analyzed. Patient-reported outcome assessments included: global severity, itch, and multi-item measures that assess other signs and symptoms of atopic dermatitis. Additional patient-reported outcome assessments measured depression, anxiety, fatigue, disease-specific and general health-related quality of life, and work and general productivity among employed patients.
RESULTS
Overall, 942 patients were included in this analysis. Improvements were observed from the first post-baseline assessment to week 12 across all patient-reported outcomes, including Patient Global Assessment (PtGA) score of 0/1 (35.5%, 19.8%, and 5.9% for 200 mg, 100 mg, and placebo, respectively), ≥ 4-point improvement in Night Time Itch Scale (NTIS; 57.0%, 42.7%, and 12.7%), change from baseline in Patient-Oriented Eczema Measure (POEM) score (- 11.4, - 8.2, and - 3.4), 1-point improvement in Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD; 75.2%, 65.1%, and 33.5%), Hospital Anxiety and Depression Scales (HADS) anxiety (- 2.0, - 1.7, and - 1.0) and depression (- 1.7, - 1.3, and - 0.1).
CONCLUSIONS
Abrocitinib monotherapy improved disease-specific signs/symptoms and health-related quality of life across multiple domains as reported by adult and adolescent patients with moderate-to-severe atopic dermatitis, complementing clinician-reported efficacy and safety outcomes.
CLINICAL TRIAL REGISTRATION
NCT02780167 (registered 23 May, 2016), NCT03349060 (registered 21 November, 2017), NCT03575871 (registered 3 July, 2018).
背景
特应性皮炎给患者带来了很大的负担，包括瘙痒、睡眠障碍和生活质量下降。
目的
本分析评估了中重度特应性皮炎成人和青少年患者接受每日一次口服阿布昔替尼 200mg 或 100mg 单药治疗后，疾病特异性体征/症状和健康相关生活质量的患者报告结局变化。
方法
对两项中重度特应性皮炎成人和青少年患者单药治疗的 2 期（NCT02780167）和 3 期（NCT03349060、JADE MONO-1；NCT03575871、JADE MONO-2）临床试验的汇总数据进行了分析。患者报告结局评估包括：总体严重程度、瘙痒和多项评估特应性皮炎其他体征和症状的指标。其他患者报告结局评估包括抑郁、焦虑、疲劳、疾病特异性和一般健康相关生活质量，以及在职患者的工作和一般生产力。
结果
总体而言，该分析共纳入 942 例患者。所有患者报告结局均从基线首次评估后第 12 周开始改善，包括患者整体评估（PtGA）评分 0/1（200mg、100mg 和安慰剂组分别为 35.5%、19.8%和 5.9%）、夜间瘙痒严重程度量表（NTIS）改善≥4 分（57.0%、42.7%和 12.7%）、患者导向的湿疹测量评分（POEM）从基线的变化（-11.4、-8.2 和-3.4）、特应性皮炎瘙痒和症状评估量表（PSAAD）改善 1 分（75.2%、65.1%和 33.5%）、医院焦虑和抑郁量表（HADS）焦虑评分（-2.0、-1.7 和-1.0）和抑郁评分（-1.7、-1.3 和-0.1）。
结论
阿布昔替尼单药治疗改善了中重度特应性皮炎成人和青少年患者的疾病特异性体征/症状和健康相关生活质量，补充了临床医生报告的疗效和安全性结果。
临床试验注册
NCT02780167（于 2016 年 5 月 23 日注册）、NCT03349060（于 2017 年 11 月 21 日注册）、NCT03575871（于 2018 年 7 月 3 日注册）。
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