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Fumaric Acid Ester Safe and Effective Against Psoriasis in Patients Receiving Medication for Comorbidities: Presented at EADV

By Jenny Powers

BERLIN -- October 14, 2009 -- Patients receiving medication for metabolic syndrome and cardiovascular diseases may be effectively and safely treated for psoriasis with fumaric acid ester (FAE), according to data presented at the 18th Congress of the European Academy of Dermatology and Venereology (EADV).

Diamont Thaci, J. W. Goethe University, Frankfurt am Main, Germany, conducted the Safety and Efficacy of Fumaderm in Comorbid Patients Study (FACTS). This was a retrospective study of 35 patients treated with FAE who were also receiving other medication for at least 1 comorbidity.

FAE is primarily metabolised by esterases, making the risk for drug-drug interaction relatively low, Dr. Thaci explained here at a poster presentation on October 9. Many patients with psoriasis are also receiving treatment for comorbidities, since there is a higher incidence of comorbidities -- including metabolic syndrome and cardiovascular diseases -- in this group than in the general population.

The objective of this study was to evaluate safety and efficacy of treatment with FAE in patients receiving medication for comorbidities; the Physicians Global Assessment (PGA) was used to determine the efficacy endpoint.

Of 35 patients enrolled, 63.8% had vascular disorders, 63.8% had metabolism and nutrition disorders, and 20.3% had cardiac disorders. The common comedications were agents acting on the renin-angiotensin system (51%) and those for reducing serum lipids (43%). The mean age was 60.6 years, the mean duration of psoriasis was 24.1 years, and the mean PASI score was 21.7.

At 12 months, 77.4% of patients showed a significant improvement or were clear and, at 24 months, 75.0% of patients were improved or clear.

No adverse events were observed regarding FAE and co-medication.

The researchers concluded that FAE showed very good efficacy, and safety that was unaffected by either comorbidities or related medications. The safety and efficacy of FAE were comparable to those seen in patients with psoriasis and no comorbidity.

[Presentation title: Efficacy and Safety of Fumaric Acid Ester for the Treatment of Psoriasis in Patients With Co-morbidities and Co-medication. Abstract 1194]

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