Response to fumaric acid esters for plaque type psoriasis in real-world practice is largely independent of patient characteristics at baseline – a multivariable regression analysis from the German Psoriasis Registry PsoBest

Fumaric acid esters (FAEs) are a well-established treatment option for long-term therapy of moderate to severe plaque psoriasis. This study examines effectiveness of FAEs for the treatment of plaque psoriasis in real-world practice at 12 months and if patient characteristics affect the odds of clinical response. A descriptive, multivariable logistic regression analysis was conducted in a cohort drawn from the German registry PsoBest. Baseline patient characteristics were assessed as potential treatment effect modifiers. 444 patients (mean age 47.0 years, 39.0% female) were eligible for response analysis using nonresponder imputation at month 12. Of these, 39.6% achieved clinical response, i.e. Psoriasis Area and Severity Index (PASI) ≤ 3 or skin clearance. In logistic regression analysis (<i>R</i>² = 0.114), only baseline PASI was a significant factor: patients with PASI &lt; 10 had a 4 times higher odds (<i>p</i> ≤ .001, OR 4.088), patients with PASI of 10–20 a twofold higher odds of response (<i>p</i> ≤ .044, OR 1.961) compared to those with PASI &gt; 20. Neither sex, age, body weight, disease duration, comorbidity nor pretreatment had an impact on the odds of response (<i>p</i> &gt; .05). FAEs showed a favorable response at 12 months, largely independent of patient characteristics.

富马酸酯（Fumaric acid esters, FAEs）是中重度斑块状银屑病长期治疗的成熟方案。本研究旨在考察富马酸酯在真实世界临床实践中用于治疗斑块状银屑病的12个月疗效，以及患者特征是否会影响临床应答的比值比。研究基于德国PsoBest银屑病登记队列开展描述性多变量logistic回归分析，将基线患者特征作为潜在的治疗效应调节因子进行评估。共纳入444名符合入组标准的患者（平均年龄47.0岁，女性占比39.0%），并采用非应答者插补法完成第12个月的应答分析。其中39.6%的患者达到临床应答，即银屑病面积与严重程度指数（Psoriasis Area and Severity Index, PASI）≤3或皮损完全清除。logistic回归分析结果显示（决定系数R²=0.114），仅基线PASI为显著影响因素：与PASI＞20的患者相比，PASI＜10的患者临床应答比值比升高4倍（p≤0.001，OR=4.088），PASI为10~20的患者临床应答比值比升高2倍（p≤0.044，OR=1.961）。性别、年龄、体重、病程、合并症及既往治疗均未对临床应答比值比产生显著影响（p＞0.05）。富马酸酯在12个月随访时展现出良好的治疗应答效果，且该疗效基本不受患者个体特征的影响。