Psoriasis-Centre at the Department of Dermatology, University Medical Centre Schleswig-Holstein, Kiel, Germany.
St John's Institute of Dermatology, King's College London, London, UK.
J Eur Acad Dermatol Venereol. 2018 Oct;32 Suppl 3:3-14. doi: 10.1111/jdv.15218. Epub 2018 Sep 20.
Fumaric acid esters (FAEs) are a group of small molecules that were first investigated for the treatment of psoriasis in 1959. The first fumarate-based drug - Fumaderm - was approved in Germany in 1994 for severe psoriasis and then in 2008, the label was expanded to include moderate psoriasis. Fumaderm is a combination of different FAEs: dimethyl fumarate (DMF), which is regarded as the main active component, plus calcium, magnesium and zinc salts of monoethyl fumarate (MEF). FAEs are the most frequently used first-line systemic psoriasis treatment in Germany, with an overall treatment experience comprising more than 220 000 patient-years. FAEs have demonstrated good, sustained clinical efficacy with an acceptable safety profile for the long-term treatment of patients with moderate-to-severe psoriasis. Indeed, the European S3-Guideline on the systemic treatment of Psoriasis vulgaris recommends FAEs for induction and long-term treatment. Until recently, FAEs were only licensed (for the psoriasis indication) in Germany, but were imported to many other European countries, such as The Netherlands, UK, Ireland, Austria and Italy, for the treatment of psoriasis. In 2017, the European Medicines Agency (EMA) approved Skilarence , a new oral formulation of DMF, for the treatment of adult patients with moderate-to-severe chronic plaque psoriasis in need of systemic therapy. Skilarence only contains DMF and is the first FAE for the treatment of psoriasis that has been approved by the EMA. This approval has given rise to a new oral treatment option for patients with moderate-to-severe plaque psoriasis across Europe. Here, we report the results of an expert meeting which was convened to deliver clinician-agreed consensus and real-world guidance on the clinical use of DMF in moderate-to-severe chronic plaque psoriasis. Guidance on appropriate patient selection, DMF dosage considerations, monitoring and side-effect management is offered based upon available evidence and collective real-world clinical experience.
富马酸酯（FAE）是一组小分子，于 1959 年首次被研究用于治疗银屑病。第一种基于富马酸盐的药物——Fumaderm——于 1994 年在德国获得批准，用于治疗严重银屑病，随后于 2008 年扩大了适应证，包括中度银屑病。Fumaderm 是不同 FAE 的组合：二甲基富马酸酯（DMF），被认为是主要活性成分，加上单乙基富马酸（MEF）的钙、镁和锌盐。FAE 是德国最常用的一线系统性银屑病治疗药物，总体治疗经验超过 220000 患者年。FAE 在治疗中重度银屑病患者的长期治疗中具有良好、持续的临床疗效和可接受的安全性。事实上，欧洲寻常型银屑病的 S3 指南推荐 FAEs 用于诱导和长期治疗。直到最近，FAE 仅在德国获得许可（用于银屑病适应证），但已被进口到许多其他欧洲国家，如荷兰、英国、爱尔兰、奥地利和意大利，用于治疗银屑病。2017 年，欧洲药品管理局（EMA）批准 Skilarence，一种 DMF 的新口服制剂，用于治疗需要系统治疗的中重度慢性斑块型银屑病成年患者。Skilarence 仅含有 DMF，是第一个获得 EMA 批准用于治疗银屑病的 FAE。这一批准为欧洲中重度斑块型银屑病患者提供了一种新的口服治疗选择。在此，我们报告了一次专家会议的结果，该会议旨在就 DMF 在中重度慢性斑块型银屑病中的临床应用达成临床医生一致的共识和真实世界的指导。根据现有证据和集体真实世界临床经验，提供了关于合适患者选择、DMF 剂量考虑、监测和不良反应管理的指导。
