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富马酸酯类药物治疗德国银屑病患者:常规治疗中的患者特征。

Fumaric acid esters for the treatment of psoriasis in Germany: characterising patients in routine care.

机构信息

Psoriasis-Center at the Department of Dermatology, University Medical Center Schleswig-Holstein, Campus Kiel, Arnold-Heller-Str. 3, 24105 Kiel, Germany.

Institute for Health Services Research in Dermatology and Nursing (IVDP), University Medical Center Hamburg-Eppendorf (UKE), Martinistraße 52, 20246 Hamburg, Germany.

出版信息

Eur J Dermatol. 2020 Feb 1;30(1):41-48. doi: 10.1684/ejd.2020.3709.

Abstract

BACKGROUND

Fumaric acid esters (FAE) represent the most widely-used oral systemic treatment for moderate-to-severe psoriasis in Germany. Not licensed outside Germany, little is known about the demographics of patients receiving FAE. PsoBest is a large national patient registry documenting long-term treatment of psoriasis in Germany.

OBJECTIVES

To evaluate FAE relative to methotrexate (MTX) in patients from the PsoBest registry.

MATERIALS AND METHODS

Patient demographics, disease severity at baseline and dosing regimen were reported for patients who initiated treatment with either FAE or MTX between 2007 and 2015.

RESULTS

Overall, 1,409 patients treated with FAE and 877 with MTX were analysed. At baseline, compared with the MTX cohort, patients receiving FAE were younger (45.4 vs. 50.2 years; p≤0.001) and had a lower BMI (28.0 vs. 28.3 kg/m; p≤0.023) and less nail involvement (45.4% vs. 50.7%; p≤0.013). The MTX cohort reported a greater mean duration of illness at baseline (18.2 years vs. 14.9 years; p≤0.001). In total, 85.6% and 58.5% patients in the FAE and MTX cohorts, respectively, had not received prior systemic therapy. Cardiovascular disease was the most prevalent comorbidity (FAE: 26.7%; MTX: 31.5%; p≤0.014). Health-related quality of life was similar for both cohorts (mean DLQI: 10.8 [FAE]; 10.5 [MTX]; p≤0.079). Mean FAE dose was 165.0 mg at inclusion and 406.4 mg following up-titration.

CONCLUSION

This study contributes to a better understanding of the usual practices of long-term FAE use, which may also lead to improved treatment strategies not only in Germany, but in other countries where FAE may become available in the near future.

摘要

背景

富马酸酯(FAE)是德国治疗中重度银屑病最广泛使用的口服系统药物。由于未在德国以外地区获得许可,因此对于接受 FAE 治疗的患者人群知之甚少。PsoBest 是一个大型的全国性患者登记处,记录了德国银屑病的长期治疗情况。

目的

评估 PsoBest 登记处中接受 FAE 治疗的患者与接受甲氨蝶呤(MTX)治疗的患者相比的情况。

材料和方法

报告了 2007 年至 2015 年期间开始接受 FAE 或 MTX 治疗的患者的人口统计学特征、基线时疾病严重程度和剂量方案。

结果

共分析了 1409 例接受 FAE 治疗和 877 例接受 MTX 治疗的患者。基线时,与 MTX 组相比,接受 FAE 治疗的患者更年轻(45.4 岁 vs. 50.2 岁;p≤0.001),BMI 更低(28.0 公斤/米² vs. 28.3 公斤/米²;p≤0.023),指甲受累程度更低(45.4% vs. 50.7%;p≤0.013)。MTX 组报告的基线时疾病持续时间更长(18.2 年 vs. 14.9 年;p≤0.001)。在 FAE 和 MTX 组中,分别有 85.6%和 58.5%的患者之前未接受过系统治疗。心血管疾病是最常见的合并症(FAE:26.7%;MTX:31.5%;p≤0.014)。两组患者的健康相关生活质量相似(平均 DLQI:10.8[FAE];10.5[MTX];p≤0.079)。纳入时 FAE 的平均剂量为 165.0mg,上调滴定后为 406.4mg。

结论

这项研究有助于更好地了解 FAE 的长期使用的常规做法,这不仅可能改善德国的治疗策略,也可能在其他即将推出 FAE 的国家改善治疗策略。

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