在对其他全身治疗反应不佳的银屑病患者改用阿达木单抗后,其睡眠质量和其他患者报告结局得到改善:来自开放标签 IIIB 期 PROGRESS 研究的结果。

Sleep quality and other patient-reported outcomes improve after patients with psoriasis with suboptimal response to other systemic therapies are switched to adalimumab: results from PROGRESS, an open-label Phase IIIB trial.

机构信息

Dermatology Associates, University of Connecticut Health Center, Farmington, CT 06030, USA.

出版信息

Br J Dermatol. 2012 Dec;167(6):1374-81. doi: 10.1111/bjd.12000. Epub 2012 Nov 2.

Abstract

BACKGROUND

Psoriasis is associated with poor health-related quality of life, including sleep impairment.

OBJECTIVE

To assess the extent of sleep impairment, the effect of adalimumab on sleep and other patient-reported outcomes, and correlations between changes in these outcomes and sleep quality in patients with psoriasis.

METHODS

Patients in the 16-week, open-label, Phase IIIb PROGRESS trial had chronic plaque psoriasis and suboptimal response to prior therapy (etanercept, methotrexate or narrowband ultraviolet B phototherapy). Adalimumab was self-injected subcutaneously (80 mg at week 0, then 40 mg every other week from week 1). The focus for this analysis was the Medical Outcomes Study Sleep Scale. Other patient-reported outcomes included the Dermatology Life Quality Index (DLQI), Psoriasis Area and Severity Index (PASI), Physician's Global Assessment, a visual analogue scale for psoriasis/psoriatic arthritis (PsA) pain, and the Work Productivity and Activity Index Questionnaire-Specific Health Problems.

RESULTS

Patients with psoriasis had impaired sleep at baseline. The degree of sleep impairment was significantly associated with the extent of work productivity for all sleep measures and, for some sleep measures, was associated with DLQI impairment, clinical severity measured by PASI, the presence of PsA, and depression. Adalimumab treatment significantly improved sleep quality by 15% from baseline, as well as DLQI score, pain and work productivity. The improvement in sleep was partially explained (R(2 ) = 0·16, P < 0·001) by improvements in the objectively measured psoriasis signs in PASI.

CONCLUSIONS

Adalimumab treatment improved sleep outcomes and other patient-reported outcomes including health-related quality of life, work productivity, daily activity and disease-related pain.

摘要

背景

银屑病与健康相关的生活质量差有关,包括睡眠障碍。

目的

评估睡眠障碍的程度、阿达木单抗对睡眠和其他患者报告结果的影响,以及这些结果的变化与银屑病患者睡眠质量之间的相关性。

方法

在 16 周、开放性、IIIb 期 PROGRESS 试验中,患者患有慢性斑块型银屑病,且对先前的治疗(依那西普、甲氨蝶呤或窄谱中波紫外线光疗)反应不佳。阿达木单抗皮下自我注射(第 0 周 80mg,第 1 周后每 2 周 40mg)。本分析的重点是医疗结局研究睡眠量表。其他患者报告的结果包括皮肤病生活质量指数(DLQI)、银屑病面积和严重程度指数(PASI)、医生总体评估、用于评估银屑病/银屑病关节炎(PsA)疼痛的视觉模拟量表以及工作效率和活动指数问卷-特定健康问题。

结果

银屑病患者在基线时有睡眠障碍。所有睡眠指标的工作生产力下降程度与睡眠障碍的严重程度显著相关,对于某些睡眠指标,还与 DLQI 损害、PASI 测量的临床严重程度、PsA 的存在和抑郁有关。阿达木单抗治疗可使睡眠质量从基线提高 15%,DLQI 评分、疼痛和工作生产力也得到改善。在 PASI 中客观测量的银屑病体征的改善部分解释了睡眠改善(R²=0.16,P<0.001)。

结论

阿达木单抗治疗可改善睡眠结果和其他患者报告的结果,包括健康相关的生活质量、工作生产力、日常活动和疾病相关的疼痛。

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