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依那西普治疗银屑病患者报告的改善结果:一项随机III期试验的结果

Patient-reported outcomes of psoriasis improvement with etanercept therapy: results of a randomized phase III trial.

作者信息

Krueger G G, Langley R G, Finlay A Y, Griffiths C E M, Woolley J M, Lalla D, Jahreis A

机构信息

Department of Dermatology, University of Utah Health Sciences Center, 30 N. 1900 E, Salt Lake City, UT 84132-0001, USA.

出版信息

Br J Dermatol. 2005 Dec;153(6):1192-9. doi: 10.1111/j.1365-2133.2005.06948.x.

DOI:10.1111/j.1365-2133.2005.06948.x
PMID:16307657
Abstract

BACKGROUND

Etanercept, a soluble tumour necrosis factor receptor, lessens the severity of psoriasis as measured by physician-reported clinical outcomes. Equally important is the patient perspective on the effect of etanercept therapy on daily life.

OBJECTIVES

To assess patient-reported outcomes (PROs) in patients with psoriasis receiving etanercept therapy.

METHODS

In this multinational, randomized, phase III trial, patients with psoriasis received placebo (n = 193), etanercept 50 mg per week (n = 196) or etanercept 50 mg twice weekly (n = 194) during the initial 12-week, double-blind period. Thereafter, all patients received open-label etanercept (50 mg per week). The following PROs were assessed: Dermatology Life Quality Index (DLQI), Short Form-36 Health Survey (SF-36), patient rating of pruritus, and patient global assessment of psoriasis.

RESULTS

At week 12, DLQI total score improved by 65-70% in patients receiving etanercept compared with 6% in patients receiving placebo (P < 0.0001), and improvement in DLQI was clinically meaningful (> or = 5-point improvement or 0 score) for 72-77% of patients receiving etanercept therapy. All DLQI and SF-36 subscales and the SF-36 physical and mental component summary scores demonstrated significantly greater improvement with etanercept therapy than with placebo, illustrating that etanercept benefits patients with psoriasis across multiple domains that contribute to health-related quality of life. With etanercept therapy, distributions of patient ratings of pruritus and global assessment of disease shifted from moderate to severe (baseline) to minimal to good (week 12). Etanercept-induced benefits of PROs were maintained for patients who reduced their dose after 12 weeks.

CONCLUSIONS

Etanercept therapy improves PROs in patients with psoriasis and makes a meaningful difference to their lives. These results support the efficacy profile of physician-reported clinical measures while providing a more complete understanding of the benefits experienced by patients with psoriasis treated with etanercept.

摘要

背景

依那西普是一种可溶性肿瘤坏死因子受体,根据医生报告的临床结果衡量,它可减轻银屑病的严重程度。依那西普治疗对日常生活影响的患者观点同样重要。

目的

评估接受依那西普治疗的银屑病患者的患者报告结局(PROs)。

方法

在这项多国、随机、III期试验中,银屑病患者在最初12周的双盲期接受安慰剂(n = 193)、每周一次50 mg依那西普(n = 196)或每周两次50 mg依那西普(n = 194)治疗。此后,所有患者接受开放标签的依那西普(每周50 mg)治疗。评估了以下PROs:皮肤病生活质量指数(DLQI)、简明健康调查量表(SF-36)、患者瘙痒评分以及患者对银屑病的整体评估。

结果

在第12周时,接受依那西普治疗的患者DLQI总分改善了65% - 70%,而接受安慰剂治疗的患者为6%(P < 0.

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