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度普利尤单抗对重度特应性皮炎成人患者睡眠障碍的影响。

Effect of dupilumab on sleep disturbances in adult patients with severe atopic dermatitis.

机构信息

Unit of Allergological and Pediatric Dermatology, Department of Health Sciences, University of Florence, Florence, Italy.

Department of Medical Biotechnology, Bioengineering Lab, University of Siena, Siena, Italy.

出版信息

Ital J Dermatol Venerol. 2022 Apr;157(2):142-145. doi: 10.23736/S2784-8671.21.07072-9. Epub 2021 Jul 20.

Abstract

BACKGROUND

Sleep disturbances are common in patients with atopic dermatitis (AD). Considering their relevant burden on health, routine screening of sleep disturbances seems to be very useful in AD adults' management. However, few studies have evaluated the association between sleep disturbances and AD in adults, and real-life data are lacking. The aim of this study was to assess the effect of treatment with dupilumab on sleep disturbances in adult patients with severe atopic dermatitis.

METHODS

This is a retrospective, multicenter study including patients (age ≥18 y) with severe atopic dermatitis treated with dupilumab for at least 8 months from January 2019 to January 2020. Patients were evaluated three times: at treatment initiation (T0), at 4 (T4) and 8 months (T8) from the start of treatment. At each visit disease activity was assessed by severity score (Eczema Area and Severity Index [EASI]), patient-reported outcomes (Pruritus Numerical Rating Scale [NRS], Dermatology Life Quality Index [DLQI], and Pittsburgh Sleep Quality Index [PSQI]). Kolmogorov-Smirnov Test was performed to evaluate the normality distribution, Bartlett's Test for homoscedasticity. Since the assumptions were met, ANOVA for repeated measures was performed to evaluate the mean difference of PSQI, EASI, DLQI and pruritus NRS between baseline, the 4 month and the 8 month. In addition, χ for Trend Test was performed to evaluate the increasing/decreasing prevalence of poor sleepers.

RESULTS

A total of 36 patients (15 females and 21 males) with a mean age of 42.5±14.3 (range 20-67) were included in the study. The mean score for PSQI at TO was 9.0±3.6. At week 16 (T4) the mean score for PSQI was 4.92±2.99 and at week 32 (T8), the mean score for PSQI was 4.3±3.0. EASI, NRS pruritus and DLQI significantly improved during follow-up (P<0.001) whereas PSQI improved significantly at 16 weeks (T4); however, no significant further improvement was observed at 32 weeks. Of the 31 patients (86%) with baseline PSQI≥5, 17 (54%) experienced sleep quality improvement during treatment. Overall, we observed a total of 22 patients (61.1%) having a PSQI<5 at 32 weeks.

CONCLUSIONS

Our data show effectiveness of dupilumab in improving sleep disturbances in adult patients with severe AD. However, further studies are required to understand if PSQI could serve as useful evaluating tool.

摘要

背景

特应性皮炎(AD)患者常存在睡眠障碍。鉴于其对健康的相关负担,常规筛查睡眠障碍似乎对 AD 成人患者的管理非常有用。然而,很少有研究评估 AD 成人患者的睡眠障碍与 AD 之间的关联,且缺乏真实世界的数据。本研究旨在评估度普利尤单抗治疗对重度特应性皮炎成人患者睡眠障碍的影响。

方法

这是一项回顾性、多中心研究,纳入了 2019 年 1 月至 2020 年 1 月期间接受度普利尤单抗治疗至少 8 个月的重度特应性皮炎患者(年龄≥18 岁)。患者在三个时间点进行评估:治疗开始时(T0)、治疗开始后 4 个月(T4)和 8 个月(T8)。每次就诊时,通过严重程度评分(Eczema Area and Severity Index [EASI])评估疾病活动度,通过患者报告的结局(瘙痒数字评分量表 [NRS]、皮肤病生活质量指数 [DLQI]和匹兹堡睡眠质量指数 [PSQI])评估。采用 Kolmogorov-Smirnov 检验评估正态分布,采用 Bartlett 检验评估同方差性。由于满足了假设,因此采用重复测量方差分析评估 PSQI、EASI、DLQI 和瘙痒 NRS 自基线、4 个月和 8 个月的平均差异。此外,还采用 χ²趋势检验评估睡眠不佳者的比例增加/减少情况。

结果

共纳入 36 例患者(15 例女性和 21 例男性),平均年龄为 42.5±14.3(范围 20-67)。TO 时 PSQI 的平均得分为 9.0±3.6。在第 16 周(T4),PSQI 的平均得分为 4.92±2.99,在第 32 周(T8),PSQI 的平均得分为 4.3±3.0。EASI、瘙痒 NRS 和 DLQI 在随访期间显著改善(P<0.001),而 PSQI 在 16 周(T4)时显著改善;然而,在 32 周时未观察到进一步显著改善。在基线 PSQI≥5 的 31 例患者(86%)中,17 例(54%)在治疗期间睡眠质量得到改善。总体而言,我们在第 32 周观察到共有 22 例患者(61.1%)PSQI<5。

结论

我们的数据显示度普利尤单抗可有效改善重度 AD 成人患者的睡眠障碍。然而,还需要进一步的研究来了解 PSQI 是否可作为有用的评估工具。

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