Servicio de Dermatologia, Hospital Universitario de la Princesa, Madrid, Spain.
J Eur Acad Dermatol Venereol. 2009 Dec;23(12):1374-82. doi: 10.1111/j.1468-3083.2009.03321.x. Epub 2009 Jun 26.
To assess patient-reported outcomes (PRO) in patients with moderate-to-severe plaque psoriasis receiving continuous or paused etanercept treatment.
In a multicentre European open-label study, one group (n = 352) received continuous therapy: 25 mg subcutaneously (SC) twice weekly (BIW) throughout 54-weeks. The other group (n = 359) received paused therapy: 50 mg SC BIW (<or= 12 weeks) until response was adequate by Physician Global Assessment; after psoriasis returned, retreatment (25 mg BIW) was begun. PRO included the Dermatology Life Quality Index (DLQI), EuroQoL-5D (EQ-5D), Hospital Anxiety and Depression Scale (HADS), and the SF-36 Vitality subscale.
At baseline, mean DLQI for patients in the continuous (12.8) and paused group (13.8), indicated significant quality-of-life impairment; mean EQ-5D utility scores were 0.65 and 0.66 for continuous and paused patients, respectively; 30.0% of continuous and 37.0% of paused patients had at least mild symptoms of depression; 40.2% and 48.6%, respectively, had at least mild symptoms of anxiety. At week 54, both groups showed statistically significant (P < 0.05) and meaningful improvement in DLQI and EQ-5D scores; improvements in HADS-D, HADS-A, and SF-36 vitality were also significant. Improvements in DLQI and EQ-5D were significantly greater in the continuous arm than the paused arm, but the differences were not meaningful. Differences between arms in HADS and SF-36 Vitality at week 54 were not significant.
At baseline, patients exhibited significant quality-of-life impairment. Both continuous and paused etanercept treatment provided improvements in PRO measures. Either regimen could be considered and care should be individualized.
评估中重度斑块状银屑病患者接受依那西普连续或中断治疗后的患者报告结局(PRO)。
在一项多中心、开放性欧洲研究中,一组(n=352)接受连续治疗:54 周内每周 2 次皮下(SC)注射 25mg;另一组(n=359)接受中断治疗:SC 50mg BIW(<或=12 周),直至医师总体评估(PGA)显示应答充分;当银屑病复发后,开始重新治疗(25mg BIW)。PRO 包括皮肤病生活质量指数(DLQI)、欧洲五维健康量表(EQ-5D)、医院焦虑抑郁量表(HADS)和 SF-36 活力分量表。
基线时,连续治疗组(12.8)和中断治疗组(13.8)的患者平均 DLQI 表明生活质量显著受损;连续治疗和中断治疗组的平均 EQ-5D 效用评分分别为 0.65 和 0.66;分别有 30.0%和 37.0%的连续和中断治疗组患者存在至少轻度抑郁症状;分别有 40.2%和 48.6%的患者存在至少轻度焦虑症状。治疗 54 周后,两组患者的 DLQI 和 EQ-5D 评分均有统计学意义(P<0.05)且有临床意义的改善;HADS-D、HADS-A 和 SF-36 活力的改善也具有统计学意义。连续治疗组的 DLQI 和 EQ-5D 改善显著大于中断治疗组,但差异无临床意义。治疗 54 周时两组患者的 HADS 和 SF-36 活力差异无统计学意义。
基线时,患者表现出显著的生活质量受损。依那西普连续或中断治疗均能改善 PRO 指标。两种治疗方案均可考虑,应个体化治疗。