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富马酸二甲酯在寻常型银屑病常规治疗中的长期应用:总体疗效良好且对关键区域有积极影响。

Long-Term Treatment with Dimethyl Fumarate for Plaque Psoriasis in Routine Practice: Good Overall Effectiveness and Positive Effect on Impactful Areas.

作者信息

Augustin Matthias, Landeck Lilla, Diemert Sebastian, Asadullah Khusru, Hammann Urte, Ertner Konstantin, Hadshiew Ina

机构信息

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

Ernst von Bergmann General Hospital, Potsdam, Germany.

出版信息

Dermatol Ther (Heidelb). 2022 May;12(5):1121-1131. doi: 10.1007/s13555-022-00714-0. Epub 2022 Apr 11.

Abstract

INTRODUCTION

Dimethyl fumarate (DMF) is an oral compound to treat plaque psoriasis. Data on the treatment of patients with psoriasis affecting impactful areas are scarce. In this interim analysis of the prospective, noninterventional SKILL study, we summarized results of DMF treatment regarding effectiveness (overall and in impactful areas) and safety.

METHODS

Data from 676 patients suffering from moderate-to-severe plaque psoriasis were analyzed after 52 weeks of DMF treatment. Of these, 257 had data available after 52 weeks. The considered impactful areas were nails, palms, soles, and scalp. Data analysis included observed cases (OC) and last observation carried forward (LOCF).

RESULTS

All effectiveness parameters improved after 52 weeks. The Psoriasis Area and Severity Index score was reduced by 79.5% (OC) and 65.7% (LOCF). Compared with baseline, improvements were shown for 70.2% of the patients in their nail psoriasis [nail-Physician Global Assessment (PGA)] and for 57.3% in palmoplantar disease (palmoplantar-PGA). The proportion of patients with scalp-PGA 0/1 (clear/almost clear) increased significantly to 79.8% (OC) and 69.3% (LOCF, both p < 0.001) (versus 37.5% and 36.6% at baseline, respectively). Significant reduction of pruritus (p < 0.001) was also observed. No unexpected adverse drug reactions were observed.

CONCLUSION

Long-term treatment with DMF in routine practice showed good overall effectiveness and safety, and a positive effect on plaque-psoriasis-affected impactful areas.

摘要

引言

富马酸二甲酯(DMF)是一种用于治疗斑块状银屑病的口服化合物。关于治疗影响重要部位的银屑病患者的数据很少。在这项前瞻性、非干预性SKILL研究的中期分析中,我们总结了DMF治疗的有效性(总体及在重要部位)和安全性结果。

方法

对676例中重度斑块状银屑病患者进行DMF治疗52周后的数据分析。其中,257例在52周后有可用数据。所考虑的重要部位为指甲、手掌、脚掌和头皮。数据分析包括观察病例(OC)和末次观察结转(LOCF)。

结果

52周后所有有效性参数均有所改善。银屑病面积和严重程度指数评分降低了79.5%(OC)和65.7%(LOCF)。与基线相比,70.2%的患者指甲银屑病[指甲-医生整体评估(PGA)]有所改善,掌跖疾病患者中有57.3%(掌跖-PGA)有所改善。头皮-PGA为0/1(清除/几乎清除)的患者比例显著增加至79.8%(OC)和69.3%(LOCF,两者p<0.001)(基线时分别为37.5%和36.6%)。还观察到瘙痒显著减轻(p<0.001)。未观察到意外的药物不良反应。

结论

在常规实践中,DMF长期治疗显示出良好的总体有效性和安全性,对受斑块状银屑病影响的重要部位有积极作用。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f783/9110590/58c9577b61b2/13555_2022_714_Fig1_HTML.jpg

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