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巴瑞替尼治疗中重度特应性皮炎成人患者的睡眠、瘙痒改善和生活质量提高:来自 3 期临床试验的结果。

Improvement in sleep and itch and enhanced quality of life in adult patients with moderate-to-severe atopic dermatitis: results from a phase 3 trial of baricitinib therapy.

机构信息

Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.

Oregon Health and Science University, Portland, OR, USA.

出版信息

J Dermatolog Treat. 2022 Jun;33(4):2057-2062. doi: 10.1080/09546634.2021.1914308. Epub 2021 Jun 28.

DOI:10.1080/09546634.2021.1914308
PMID:34176407
Abstract

BACKGROUND

Baricitinib previously demonstrated improvements in itch and sleep disturbance versus placebo in adults with moderate-to-severe atopic dermatitis (AD).

OBJECTIVES

Examine if itch and sleep improvements are associated with better quality of life (QoL) and productivity in patients with AD.

METHODS

Data were drawn from BREEZE-AD5 (NCT03435081). Itch and sleep improvement at Week 16 were defined using ≥4-point improvements in the Itch Numeric Rating Scale and ≥1.5 decreases in the number of nighttime awakenings since baseline, respectively. Patients with and without improvements were compared on Dermatology Life Quality Index (DLQI) and Work Productivity and Activity Impairment-AD scores. Changes from baseline were analyzed using ANCOVA with last observation carried forward. Proportions were analyzed using logistic regression with non-responder imputation.

RESULTS

Greater proportions of patients with versus without itch improvement indicated no impact of AD on QoL (37.7 vs. 1.8%). Patients with itch improvement had greater decreases in work time impaired (-29.3 vs. -5.6%). More patients with versus without sleep improvement reported no effect of AD on QoL (25.5 vs. 1.1%); patients with better sleep experienced larger reductions in work time spent impaired (-33.3 vs. -6.1%).

CONCLUSIONS

Patients with AD who experienced itch and sleep improvement had significantly better QoL and productivity.

摘要

背景

巴瑞替尼先前在中重度特应性皮炎(AD)成人患者中显示出在瘙痒和睡眠障碍方面优于安慰剂的改善。

目的

研究瘙痒和睡眠改善是否与 AD 患者的生活质量(QoL)和生产力的提高相关。

方法

数据来自 BREEZE-AD5(NCT03435081)。瘙痒和睡眠在第 16 周的改善分别定义为瘙痒数字评分量表改善≥4 分,以及自基线以来夜间觉醒次数减少≥1.5。分别比较有和无改善的患者在皮肤病生活质量指数(DLQI)和工作效率和活动障碍-AD 评分上的差异。采用最后一次观测值结转的协方差分析(ANCOVA)分析从基线的变化。采用逻辑回归(non-responder imputation)分析比例。

结果

与无瘙痒改善的患者相比,有瘙痒改善的患者中表示 AD 对 QoL 无影响的比例更高(37.7% vs. 1.8%)。瘙痒改善的患者工作时间受损的减少更大(-29.3% vs. -5.6%)。与无睡眠改善的患者相比,有睡眠改善的患者中报告 AD 对 QoL 无影响的比例更高(25.5% vs. 1.1%);睡眠更好的患者工作时间受损的减少更大(-33.3% vs. -6.1%)。

结论

瘙痒和睡眠改善的 AD 患者具有显著更好的 QoL 和生产力。

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