Dermatologikum, Hamburg, Germany.
Dermatology. 2009;219(3):239-49. doi: 10.1159/000237871. Epub 2009 Sep 10.
To assess baseline patient-reported outcomes (PROs) and PRO improvement in patients with psoriasis administered etanercept 50 mg once weekly (QW).
Adult patients with moderate-to-severe plaque psoriasis participated in a 12-week, double-blind, controlled trial in which they received etanercept 50 mg QW (n = 96) or placebo QW (n = 46), followed by a 12-week, open-label extension in which they received etanercept 50 mg QW (etanercept-etanercept, n = 90; placebo-etanercept, n = 36). Patients completed the Dermatology Life Quality Index (DLQI), EuroQoL-5D (EQ-5D) and Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) at baseline and subsequent study visits.
At baseline, DLQI and EQ-5D scores indicated significant quality of life (QoL) impairment, and FACIT-F scores suggested more fatigue than in the general population. At week 12, etanercept 50 mg QW provided statistically significantly (p < 0.05) and clinically meaningfully greater improvement in DLQI and EQ-5D utility scores than placebo, but not in FACIT-F scores. After 24 weeks of etanercept, the mean DLQI suggested psoriasis had a small effect on QoL, while EQ-5D and FACIT-F scores were comparable to population norms.
Patients with moderate-to-severe psoriasis entered this trial with serious PRO impairment. At week 12, etanercept 50 mg QW provided significant QoL improvements compared with placebo. After 24 weeks of etanercept, the patients' serious PRO impairment had largely abated.
评估接受依那西普每周一次 50mg 治疗的中重度斑块状银屑病患者的基线患者报告结局(PRO)和 PRO 改善情况。
中重度斑块状银屑病成年患者参与了一项为期 12 周的双盲对照试验,他们接受依那西普 50mg 每周一次(n=96)或安慰剂每周一次(n=46)治疗,随后进入为期 12 周的开放标签扩展期,接受依那西普 50mg 每周一次治疗(依那西普-依那西普,n=90;安慰剂-依那西普,n=36)。患者在基线和随后的研究访视时完成皮肤病生活质量指数(DLQI)、欧洲五维健康量表(EQ-5D)和慢性疾病治疗疲劳功能评估量表-疲劳(FACIT-F)。
基线时,DLQI 和 EQ-5D 评分表明生活质量(QoL)严重受损,FACIT-F 评分表明比一般人群更疲劳。在第 12 周,依那西普 50mg 每周一次治疗与安慰剂相比,在 DLQI 和 EQ-5D 效用评分方面提供了统计学显著(p<0.05)和临床有意义的改善,但在 FACIT-F 评分方面没有改善。接受依那西普治疗 24 周后,平均 DLQI 提示银屑病对 QoL 的影响较小,而 EQ-5D 和 FACIT-F 评分与人群正常值相当。
中重度斑块状银屑病患者入组本试验时存在严重的 PRO 受损。在第 12 周,依那西普 50mg 每周一次治疗与安慰剂相比,提供了显著的 QoL 改善。接受依那西普治疗 24 周后,患者的严重 PRO 受损已基本缓解。