接受二甲基富马酸（DMF）治疗的中重度斑块型银屑病成人的生活质量结局：BRIDGE 研究的事后分析。
Quality of life outcomes in adults with moderate-to-severe plaque psoriasis treated with dimethylfumarate (DMF): a post hoc analysis of the BRIDGE study.
机构信息
Department of Dermatology, Radboud University Medical Centre, Nijmegen, The Netherlands.
Department of Dermatology, Medical University of Vienna, Vienna, Austria.
出版信息
J Eur Acad Dermatol Venereol. 2020 Jan;34(1):119-126. doi: 10.1111/jdv.15922. Epub 2019 Oct 17.
BACKGROUND
Psoriasis is a chronic inflammatory skin disease associated with quality of life (QoL) impairment. BRIDGE was a randomized, double-blind, phase III study comparing the efficacy and safety of dimethylfumarate (DMF) with a fixed combination of fumaric acid esters (FAE) or placebo for the treatment of moderate-to-severe psoriasis.
OBJECTIVES
This post hoc analysis investigated treatment effect on QoL overall and by patient subgroups categorized by disease severity. Week 8 efficacy responses were also investigated as possible predictors of Week 16 Dermatology Life Quality Index (DLQI) outcomes.
METHODS
Patients were randomized to receive a maximum daily dose of 720 mg of DMF, FAE (gradual up-titration) or placebo for 16 weeks. Psoriasis Area Severity Index, Body Surface Area, Physician's Global Assessment and DLQI were assessed at baseline, Weeks 8 and 16. DLQI 0-1 indicated 'no effect on patient life'. Associations between baseline severity, Week 16 DLQI and Week 8 efficacy (as observed cases) were also examined.
RESULTS
At baseline, 671 patients were included in the full analysis set (267 randomized to DMF, 273 to FAE and 131 to placebo). DMF was superior to placebo (P < 0.001) and not significantly different to FAE regarding Week 16 DLQI outcomes (P > 0.05). Baseline disease severity did not impact DLQI outcomes at Week 16. In DMF- and FAE-treated patients, Week 8 PASI 50/75 responders reported better DLQI responses at Week 16 vs non-responders (P < 0.05). Week 8 PASI ≤ 3 and/or PGA 0-1 responders were also more likely to report DLQI 0-1 at Week 16 vs non-responders (P < 0.05).
CONCLUSION
Dimethylfumarate significantly improved DLQI outcomes vs. placebo and was not affected by baseline disease severity. Efficacy responses (PASI 50/75, PASI ≤3 and PGA 0-1) as early as Week 8 were predictive of QoL outcomes at Week 16 in DMF- and FAE-treated patients.
背景
银屑病是一种慢性炎症性皮肤病，会导致生活质量（QoL）受损。BRIDGE 是一项随机、双盲、III 期研究，比较了二甲基富马酸（DMF）与富马酸酯的固定组合（FAE）或安慰剂治疗中重度银屑病的疗效和安全性。
目的
本事后分析研究了整体治疗对 QoL 的影响，并按疾病严重程度分类的患者亚组进行了研究。还研究了第 8 周的疗效反应作为第 16 周皮肤病生活质量指数（DLQI）结果的可能预测因子。
方法
患者被随机分配接受最大每日剂量 720mg 的 DMF、FAE（逐渐加量）或安慰剂治疗 16 周。在基线、第 8 周和第 16 周评估银屑病面积严重程度指数、体表面积、医生全球评估和 DLQI。DLQI 0-1 表示“对患者生活无影响”。还检查了基线严重程度与第 16 周 DLQI 和第 8 周疗效（作为观察病例）之间的关系。
结果
在基线时，671 例患者被纳入全分析集（267 例随机分配至 DMF 组，273 例至 FAE 组，131 例至安慰剂组）。与安慰剂相比，DMF 显著优于安慰剂（P<0.001），与 FAE 相比，第 16 周 DLQI 结果无显著差异（P>0.05）。基线疾病严重程度并不影响第 16 周的 DLQI 结果。在 DMF 和 FAE 治疗的患者中，第 8 周 PASI 50/75 应答者在第 16 周的 DLQI 反应优于无应答者（P<0.05）。第 8 周 PASI≤3 和/或 PGA 0-1 应答者也更有可能在第 16 周报告 DLQI 0-1，而无应答者则不太可能（P<0.05）。
结论
与安慰剂相比，二甲基富马酸显著改善了 DLQI 结局，且不受基线疾病严重程度的影响。早在第 8 周，疗效反应（PASI 50/75、PASI≤3 和 PGA 0-1）即可预测 DMF 和 FAE 治疗患者第 16 周的 QoL 结局。
Zotero 插件