Department of Dermatology, University of Rome Tor Vergata, Italy.
Int J Immunopathol Pharmacol. 2010 Apr-Jun;23(2):503-9. doi: 10.1177/039463201002300212.
To assess the long-term efficacy and safety profile and the patient-reported outcomes (PRO) in patients with moderate-to-severe plaque-type psoriasis receiving continuous etanercept treatment. An open-label study was conducted to evaluate etanercept as long-term treatment for moderate-to-severe plaque psoriasis. Continuous therapy was administered at a dose of 50 mg subcutaneously twice weekly for 12 weeks followed by a continuous treatment with 50 mg subcutaneously once weekly or 25 mg twice weekly throughout a 96-week study. The primary measure of efficacy was the proportion of patients with PASI 75 at week 24, 48 and 96. Patient-reported outcomes (PRO) were also assessed during the study, at week 24, 48 and 96, including the Dermatology Life Quality Index (DLQI) and the Psoriasis Disability Index (PDI). At baseline, mean PASI score, DLQI and PDI for patients eligible to initiate treatment with etanercept showed significant disease severity, quality-of-life impairment and psoriasis-related disability. At week 96, patients showed statistically significant and meaningful improvements. The continuous etanercept regimen provided a consistent improvement in both clinical disease parameters and PRO measures.
评估中重度斑块状银屑病患者接受依那西普连续治疗的长期疗效和安全性概况以及患者报告的结局（PRO）。进行了一项开放性研究，以评估依那西普作为中重度斑块状银屑病的长期治疗。连续治疗 12 周，每周两次给予 50mg 皮下注射，然后在 96 周的研究期间，每周一次给予 50mg 皮下注射或每周两次给予 25mg 皮下注射。疗效的主要衡量标准是 PASI75 的患者比例在第 24、48 和 96 周。在研究期间还评估了患者报告的结局（PRO），包括第 24、48 和 96 周的皮肤病生活质量指数（DLQI）和银屑病残疾指数（PDI）。在基线时，有资格开始依那西普治疗的患者的平均 PASI 评分、DLQI 和 PDI 表明疾病严重程度、生活质量受损和银屑病相关残疾显著。在第 96 周，患者表现出统计学上显著和有意义的改善。依那西普连续方案为临床疾病参数和 PRO 指标提供了一致的改善。
