Although not approved for treatment of psoriasis in the United States, fumaric acid esters (FAEs) are currently one of the most commonly used psoriasis treatments in Germany.
A narrative review by Deepak MW Balak, Department of Dermatology, Erasmus Medical Center, Rotterdam, the Netherlands, based on a literature search in Medline and Embase databases, detailed results of six randomized controlled trials and 29 observational studies.
FAEs were evaluated in a total of more than 3,400 patients, and 50% to 70% of patients achieved at least 75% improvement in psoriasis severity after 16 weeks of treatment, according to the results published in Psoriasis: Targets and Therapy.
The most commonly reported adverse events of FAEs included gastrointestinal complaints and flushing symptoms, which resulted in treatment discontinuation in up to 6% to 40% of patients. Lymphocytopenia, eosinophilia, and proteinuria are also commonly observed during FAE treatment, but rarely result in treatment discontinuation.
The long-term safety profile of continuous FAE treatment is favorable without an increased risk for infections, malignancies, or other serious adverse events, according to the review study findings. In addition, there are no known drug-interactions for FAEs, and the 2009 European evidence-based S3-guidelines suggest it as a first-line systemic treatment for moderate-to-severe plaque psoriasis.
The mechanisms of action by which FAEs improve psoriasis are not yet completely understood. FAE are thought to elicit their effects through multiple immunomodulating effects. Recent experimental studies have described various immunomodulatory, anti-inflammatory, and anti-oxidative properties of FAEs.
Based on the broad range of FAE’s effects, these drugs are now being applied for various other diseases, including Huntington disease, myocardial infarction and asthma.
“The use of FAE in the treatment of psoriasis could be improved with approval by regulatory agencies, optimization of the FAE formulation and treatment tolerability, and long-term comparison to other systemic psoriasis treatments,” concluded the researchers.
FAEs, also known as fumarates, are ester derivatives of fumaric acid, were introduced in 1959 as a systemic psoriasis treatment and further developed during the 1970s through the 1990s in Germany, Switzerland, and the Netherlands.