A safety evaluation of dimethyl fumarate in moderate-to-severe psoriasis

ABSTRACT

Introduction: Psoriasis is a chronic inflammatory disorder affecting skin, nails and joints. Systemic therapy of psoriasis is based upon several drugs which include fumaric acid esters (FAEs), initially introduced in 1959. Since 2017, one of the key substances among FAE spectrum (dimethyl fumarate; DMF) was registered by the European Medicines Agency (EMA) for the treatment of moderate-to-severe psoriasis vulgaris.

Areas covered: This article covers the basic concepts underlying usefulness of DMF in psoriasis and extensively reviews the studies, which included its use in monotherapy of this dermatosis, with a particular emphasis on safety aspects and adverse events (AEs).

Expert opinion: DMF monotherapy is a valuable systemic modality in the management of moderate-to-severe psoriasis as proved by a recent phase III study. AEs associated with DMF therapy are frequent, usually of mild severity, with a dose-independent manner. Occasionally they are burdensome and require drug discontinuation. The most common AEs comprise gastrointestinal symptoms, flushing and white blood cell count abnormalities. The latter require strict monitoring to prevent serious complications. Acknowledging the possibility of AEs, the use of DMF in moderate-to-severe psoriasis is encouraged while the need of further studies still remains.

KEYWORDS:

• Dimethyl fumarate
• psoriasis
• safety
• adverse events

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Declaration of Interest

JC Szepietowski participated in BRIDGE study as one of principal investigators and received funding from Almirall S.A. He also served as a member for Advisory Board of Almirall. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Reviewer Disclosures

A peer reviewer on this manuscript has disclosed that they have worked as a consultant for Almirall, which produces DMF. All other peer reviewers on this manuscript have no relevant financial or other disclosures to declare.

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Funding

This paper was not funded.