Dimethyl Fumarate: A Review in Moderate to Severe Plaque Psoriasis
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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.
During the peer review process, the manufacturer of DMF was also offered an opportunity to review this article. Changes resulting from comments received were made on the basis of scientific and editorial merit.
Compliance with Ethical Standards
The preparation of this review was not supported by any external funding.
Conflict of interest
Hannah Blair is a salaried employee of Adis/Springer, is responsible for the article content and declares no relevant conflicts of interest.
Additional information about this Adis Drug Review can be found at http://www.medengine.com/Redeem/D15CF06028AE6C06.
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