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Oral fumaric acid esters for psoriasis.

Ausama Atwan1, John R Ingram, Rachel Abbott

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Oral fumaric acid esters (FAE) show promise for treating psoriasis, outperforming placebo and potentially matching methotrexate efficacy. However, common side effects like gastrointestinal issues and flushing occur, though serious adverse events were not observed in short-term studies.

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Area of Science:

  • Dermatology
  • Systemic Therapy
  • Inflammatory Skin Conditions

Background:

  • Psoriasis is a chronic inflammatory skin disease significantly impacting quality of life.
  • Oral fumaric acid esters (FAE), containing dimethyl fumarate (DMF), are used systemically for moderate to severe psoriasis, particularly in Germany.

Purpose of the Study:

  • To evaluate the efficacy and safety of oral fumaric acid esters (FAE) as a treatment for psoriasis.

Main Methods:

  • Systematic review of randomized controlled trials (RCTs) comparing FAE with placebo or other treatments.
  • Searched multiple databases (Cochrane, MEDLINE, EMBASE, LILACS) and trial registers up to May 2015.
  • Primary outcomes included Psoriasis Area and Severity Index (PASI) score improvement and treatment discontinuation due to adverse effects.

Main Results:

  • FAE demonstrated superiority over placebo in achieving PASI 50 (64% vs. 14%), with a number needed to treat (NNT) of 2.
  • More participants experienced adverse effects with FAE (76%), primarily gastrointestinal disturbances and flushing, compared to placebo (16%) (NNT to harm of 2).
  • Compared to methotrexate (MTX), FAE showed similar efficacy in achieving PASI 50/75/90, though MTX trended towards better PASI scores; adverse event profiles were comparable, with more flushing reported with FAE.

Conclusions:

  • Oral fumaric acid esters (FAE) appear more effective than placebo for psoriasis and comparable to methotrexate, though evidence is limited by study reporting.
  • Common adverse effects of FAE include gastrointestinal issues and flushing; no serious adverse events were reported in short-term studies.
  • Further research is needed due to limitations in study duration and reporting of the included randomized controlled trials.