Springer, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand.
Drugs. 2018 Jan;78(1):123-130. doi: 10.1007/s40265-017-0854-6.
Fumaric acid esters (FAEs) have been used in the treatment of psoriasis in some European countries for over 20 years, and are recommended in the European guidelines for the management of moderate to severe plaque psoriasis. Dimethyl fumarate (Skilarence; hereafter referred to as DMF) is an orally administered FAE indicated for the treatment of moderate to severe plaque psoriasis in adults in need of systemic medicinal therapy; unlike other available FAEs, it is not formulated in combination with monoethyl fumarate salts. EU approval was based on results of the phase III BRIDGE trial, and supported by previous publications of FAE preparations, including a combination of FAEs containing dimethyl fumarate and monoethyl fumarate salts (DMF/MEF; Fumaderm). In the BRIDGE trial, DMF was superior to placebo in terms of the proportion of patients achieving a ≥ 75% improvement from baseline in the Psoriasis Area and Severity Index (PASI 75) and a Physician Global Assessment score of 0 (clear) or 1 (almost clear) at week 16. DMF was also noninferior to DMF/MEF for PASI 75 at week 16. Patients receiving DMF also reported clinically meaningful improvements in body surface area involvement and health-related quality of life. The safety profile of DMF was similar to that of DMF/MEF, and no major or unexpected safety concerns were identified. The most common adverse events (flushing and gastrointestinal disorders) occurred mainly during the first few weeks of treatment. Currently available data indicate that DMF is an effective oral systemic treatment option for patients with moderate to severe plaque psoriasis.
富马酸酯（FAE）在一些欧洲国家已被用于治疗银屑病超过 20 年，并且被欧洲中度至重度斑块状银屑病管理指南推荐。富马酸二甲酯（Skilarence；以下简称 DMF）是一种口服 FAE，适用于需要全身药物治疗的中度至重度斑块状银屑病成人患者；与其他可用的 FAE 不同，它不是与单乙基富马酸盐联合配制的。欧盟的批准基于 III 期 BRIDGE 试验的结果，并得到了以前 FAE 制剂出版物的支持，包括含有富马酸二甲酯和单乙基富马酸盐的 FAE 制剂的组合（DMF/MEF；Fumaderm）。在 BRIDGE 试验中，与安慰剂相比，DMF 能使更多患者达到从基线开始的银屑病面积和严重程度指数（PASI 75）改善≥75%和医生整体评估评分为 0（清除）或 1（几乎清除）的比例在第 16 周更高。DMF 在第 16 周的 PASI 75 方面也不劣于 DMF/MEF。接受 DMF 治疗的患者也报告了身体表面积受累和健康相关生活质量的临床意义上的改善。DMF 的安全性与 DMF/MEF 相似，没有发现重大或意外的安全性问题。最常见的不良反应（潮红和胃肠道疾病）主要发生在治疗的最初几周。目前可用的数据表明，DMF 是一种有效的中度至重度斑块状银屑病的口服全身治疗选择。
