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在真实世界中接受生物制剂治疗的斑块状银屑病日本患者中,在开始或转换生物制剂时使用皮肤病生活质量指数的效用:来自 ProLOGUE 研究的结果。

Utility of the Dermatology Life Quality Index at initiation or switching of biologics in real-life Japanese patients with plaque psoriasis: Results from the ProLOGUE study.

机构信息

Department of Dermatology, Fukuoka University Faculty of Medicine, Fukuoka, Japan.

Medical Affairs, Kyowa Kirin Co., Ltd., Tokyo, Japan.

出版信息

J Dermatol Sci. 2021 Mar;101(3):185-193. doi: 10.1016/j.jdermsci.2021.01.002. Epub 2021 Jan 7.

DOI:10.1016/j.jdermsci.2021.01.002
PMID:33495058
Abstract

BACKGROUND

Plaque psoriasis significantly affects patients' health-related quality of life. To aid treatment decisions, not only objective assessment by physicians but also subjective assessment by patients is important.

OBJECTIVE

To assess the significance of Dermatology Life Quality Index (DLQI) evaluation at the time of biologics introduction in clinical practice in Japanese patients with plaque psoriasis.

METHODS

This was a single-arm, open-label, multicenter study. At baseline, Psoriasis Area and Severity Index (PASI) and DLQI scores were measured and stratified based on DLQI scores ≥6/≤5 and PASI scores ≤10/>10. Other patient-reported outcomes assessed included EQ-5D-5L, itch numerical rating scale (NRS), skin pain NRS, Generalized Anxiety Disorder-7 (GAD-7), Patient Health Questionnaire-8 (PHQ-8), Sleep Problem Index-II (SPI-II), and Treatment Satisfaction Questionnaire for Medication-9 (TSQM-9).

RESULTS

Of the 73 enrolled patients, 23 had PASI scores ≤10. Those with PASI/DLQI scores >10/≥6 had a significantly higher median PASI score than those with PASI/DLQI scores >10/≤5 (p = 0.0125). Regardless of PASI scores (>10/≤10), median itch NRS and GAD-7 scores were significantly higher in patients with DLQI scores ≥6 than in those with DLQI scores ≤5 (itch NRS, p = 0.0361 and p = 0.0086, respectively; GAD-7, p = 0.0167 and p = 0.0273, respectively). Patients with PASI/DLQI scores ≤10/≥6 had significantly higher skin pain NRS (p = 0.0292) and PHQ-8 (p = 0.0255) scores and significantly lower median SPI-II scores (p = 0.0137) and TSQM-9 Effectiveness domain scores (p = 0.0178) than those with PASI/DLQI scores ≤10/≤5.

CONCLUSION

DLQI may be useful for assessing patients' concerns that cannot be identified by PASI alone while initiating biologics or switching from other biologics in clinical practice.

摘要

背景

斑块状银屑病显著影响患者的生活质量。为了辅助治疗决策,不仅需要医生进行客观评估,还需要患者进行主观评估。

目的

评估在日本斑块状银屑病患者中,生物制剂引入临床实践时使用皮肤病生活质量指数(DLQI)评估的意义。

方法

这是一项单臂、开放性、多中心研究。在基线时,测量银屑病面积和严重程度指数(PASI)和 DLQI 评分,并根据 DLQI 评分≥6/≤5 和 PASI 评分≤10/>10 进行分层。评估的其他患者报告结果包括 EQ-5D-5L、瘙痒数字评分量表(NRS)、皮肤疼痛 NRS、广泛性焦虑障碍 7 项(GAD-7)、患者健康问卷 8 项(PHQ-8)、睡眠问题指数-Ⅱ(SPI-Ⅱ)和药物治疗满意度问卷 9 项(TSQM-9)。

结果

在纳入的 73 名患者中,23 名患者的 PASI 评分≤10。PASI/DLQI 评分>10/≥6 的患者的中位数 PASI 评分显著高于 PASI/DLQI 评分>10/≤5 的患者(p=0.0125)。无论 PASI 评分(>10/≤10)如何,DLQI 评分≥6 的患者的中位数瘙痒 NRS 和 GAD-7 评分均显著高于 DLQI 评分≤5 的患者(瘙痒 NRS,p=0.0361 和 p=0.0086;GAD-7,p=0.0167 和 p=0.0273)。PASI/DLQI 评分≤10/≥6 的患者的皮肤疼痛 NRS(p=0.0292)和 PHQ-8(p=0.0255)评分显著更高,而 SPI-Ⅱ评分(p=0.0137)和 TSQM-9 疗效域评分(p=0.0178)显著更低。

结论

在临床实践中,当开始使用生物制剂或从其他生物制剂转换时,DLQI 可能有助于评估 PASI 单独无法识别的患者关注问题。

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