title: Long-term safety aspects of systemic therapy with fumaric acid esters in severe psoriasis.
abstract: 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.
  
  
  OBJECTIVE
  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.
authors.affiliation: Department of Dermatology, B1-Q, Leiden University Medical Center, PO Box 9600, 2300 RC Leiden, The Netherlands.
authors.forename: J J
authors.initials: JJ
authors.lastname: Hoefnagel
authors.forename: H B
authors.initials: HB
authors.lastname: Thio
authors.forename: R
authors.initials: R
authors.lastname: Willemze
authors.forename: J N
authors.initials: JN
authors.lastname: Bouwes Bavinck
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D003404:Creatinine / Q000097:blood; D003879:Dermatologic Agents / Q000009:adverse effects*; D004334:Drug Administration Schedule; D005260:Female; D005650:Fumarates / Q000009:adverse effects* / Q000627:therapeutic use; D006801:Humans; D008099:Liver / Q000187:drug effects / Q000201:enzymology; D008231:Lymphopenia / Q000139:chemically induced; D008297:Male; D008875:Middle Aged; D011565:Psoriasis / Q000188:drug therapy*
chemical_list: D003879:Dermatologic Agents; D005650:Fumarates; D003404:Creatinine