Skip to main content

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

Buy Article:

$51.00 plus tax (Refund Policy)

Abstract:

Summary 

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.

Keywords: fumaric acid esters; long-term safety; psoriasis

Document Type: Research Article

DOI: https://doi.org/10.1046/j.1365-2133.2003.05433.x

Affiliations: 1: Department of Dermatology, B1-Q, Leiden University Medical Center, PO Box 9600, 2300 RC Leiden, the Netherlands 2: Department of Dermatology, Erasmus Medical Center, Rotterdam, the Netherlands

Publication date: 2003-08-01

  • Access Key
  • Free content
  • Partial Free content
  • New content
  • Open access content
  • Partial Open access content
  • Subscribed content
  • Partial Subscribed content
  • Free trial content
Cookie Policy
X
Cookie Policy
Ingenta Connect website makes use of cookies so as to keep track of data that you have filled in. I am Happy with this Find out more