The Role of Fumaric Acid and Derivatives in the Management of Psoriasis

Author(s): Sharone

Psoriasis is a multi-system, chronic, inflammatory disorder with increased morbidity and mortality. Current treatment modalities involve topical agents, systemic agents including biologics and phototherapy. Owing to the chronicity of the disease, long term therapy is much needed and options have to be evaluated in terms of efficacy and safety profile. Fumaric acid esters have been widely in use for the treatment of psoriasis in Germany as a licensed drug for more than 2 decades. FAE have various immunomodulatory, anti-inflammatory, and anti-oxidative properties that have caused it to be a possible emerging treatment modality for patients suffering from the disease. Due to the success in treatment, though unlicensed, it is being used in several other European countries. To date, 10 randomized controlled trials and 38 observational studies have evaluated FAE in a combined total of 5,003 patients. The efficacy and safety profile of FAE is favorable. About 50%–70% of patients achieve at least 75% improvement in psoriasis severity after 16 weeks of treatment. The safety profile of FAEs was marked and studied. Intolerable gastrointestinal complaints and flushing led to early treatment withdrawal in 6-40%. However these gradually improve after 3 months of treatment. Lymphocytopenia, eosinophilia, increased liver enzymes, and proteinuria were commonly observed, but rarely resulted in disruption in treatment. Studies with long-term data are much needed for further assessment. The 2009 European evidencebased S3-guidelines on psoriasis treatment recommend FAE and suggest it as a first-line systemic treatment for moderate-tosevere plaque psoriasis. This review is aimed to give an overview of the role of FAE treatment in the management of psoriasis.