The first European expert consensus on clinical use of dimethyl fumarate for plaque psoriasis has been published.
The Journal of the European Academy of Dermatology and Venereology (JEADV) has published the first expert consensus on dimethyl fumarate clinical use in moderate-to-severe plaque psoriasis.
The consensus report was drawn by 10 dermatologists from across Europe with extensive clinical experience in managing psoriasis patients and significant experience of using FAEs in clinical practice. Some of them also have experience in drawing up national and European-level clinical Guidelines in psoriasis, including the 2015 update of the European S-3 Guidelines on the systemic treatment of psoriasis.
The main conclusion of the Consensus is that the favourable safety profile of fumaric acid esters (FAEs) together with their long-term efficacy provide a first-line therapeutic option to achieve sustained disease control for patients with moderate-to-severe chronic plaque psoriasis, when the disease cannot be adequately controlled with topical treatments and phototherapy. Also, the Consensus states that dimethyl fumarate for plaque psoriasis is considered to be the main active ingredient accounting for the clinical effects.
According to Prof. Ulrich Mrowietz, from the Universitätsklinikum Schleswig-Holstein (Germany) and one of the authors of the consensus, “this class of drug has sustained clinical efficacy with a favourable safety profile, and the European S-3 Guidelines on systemic treatment of plaque psoriasis recommend FAEs for induction treatment and long-term treatment of psoriasis”. And adds “the results of an experts meeting which has convened to deliver expert-agreed consensus and real-world guidance on the clinical use of dimethyl fumarate for plaque psoriasis offers guidance on appropriate patient selection, DMF dosage considerations, monitoring and side-effects management”.
Psoriasis is a chronic immune disease that appears on the skin. It affects an estimated 7.8 million adults in Europe and approximately 125 million people worldwide. It is a non-contagious disorder that accelerates the growth cycle of skin cells and results in thick scaly areas of skin. The most common form of psoriasis, called plaque psoriasis, appears as red, raised areas of skin covered with flaky white scales, which may be itchy and painful and can crack and bleed. Despite different treatment options existing, many people with plaque psoriasis continue to struggle with the ongoing, persistent nature of this chronic disease.
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Patient profile and selection: It was concluded by the panel that DMF should be considered a first-line treatment option in systemic-naïve patients with moderate-to-severe psoriasis. In terms of patient population, fumarates are equally effective in male and female patients, and young and elderly patients. There is no evidence of drug-drug interactions, as FAEs are not metabolised by common pathways.
Dosage considerations: DMF allows flexible and individualised dosing according to patient clinical response and tolerability. It is recommended to begin treatment with DMF with low initial dose followed by subsequent gradual increases. Onset of a clinical response can be seen as early as week 3, however maximum efficacy is usually seen after 24 weeks.
Side-effects management: FAEs have a well-characterised side-effect profile and most adverse effects experienced are mild and do not lead to discontinuation of treatment. DMF is an anti-inflammatory and immunomodulatory agent and is not associated with an increased risk of infections or malignancies.
The project received financial support from Almirall S.A., nevertheless no influence on its development and context was done as it reflects independent experts’ opinion.