Long-term safety aspects of systemic therapy with fumaric acid esters in severe psoriasis

Br J Dermatol. 2003 Aug;149(2):363-9. doi: 10.1046/j.1365-2133.2003.05433.x.


Background: Therapy with fumaric acid esters (FAE) has been shown to be safe and effective in patients with severe psoriasis in several clinical studies with limited follow-up periods. In view of the chronic character of psoriasis, long-term safety aspects are of major importance in determining the suitability of a drug during prolonged periods of treatment.

Objectives: To investigate adverse events of therapy with systemic FAE with follow-up periods of up to 14 years, in order to determine safety aspects of their long-term use in patients with severe psoriasis.

Methods: Current and/or past therapeutic use of FAE was reviewed in 66 patients with severe psoriasis.

Results: Forty-one of 66 patients had received FAE for at least 1 year, and 12 of these 41 patients had received FAE for between 10 and 14 years. Adverse events were reported in 73% of the patients. These were usually mild and mainly consisting of flushing (55%), diarrhoea (42%), nausea (14%), tiredness (14%) and stomach complaints (12%). A relative lymphocytopenia was observed in 76% of patients during therapy with FAE, resulting in a permanent discontinuation of therapy with FAE in four patients. A transient eosinophilia and moderate liver enzyme elevations were observed in 14% and 25% of patients, respectively.

Conclusions: The present study indicates that FAE can be considered as a safe long-term treatment in patients with severe psoriasis.

MeSH terms

  • Adult
  • Aged
  • Aged, 80 and over
  • Creatinine / blood
  • Dermatologic Agents / adverse effects*
  • Drug Administration Schedule
  • Female
  • Fumarates / adverse effects*
  • Fumarates / therapeutic use
  • Humans
  • Liver / drug effects
  • Liver / enzymology
  • Lymphopenia / chemically induced
  • Male
  • Middle Aged
  • Psoriasis / drug therapy*


  • Dermatologic Agents
  • Fumarates
  • Creatinine