Fumaric acid esters psoriasis

In 83 patients with severe psoriasis vulgaris, the fumaric acid ester formulations Fumaderm initial and Fumaderm caused adverse effects in 62%, mainly flushing and gastrointestinal complaints, which decreased in frequency during the course of the study (6). 

In 66 patients with severe psoriasis who took fumaric acid esters for up to 14 years, there were adverse events in 73%, usually mild and mainly consisting of flushing (55%), diarrhea (42%), nausea (14%), tiredness (14%), and stomach complaints (12%) (8). There was a relative lymphocytopenia in 76%, resulting in permanent withdrawal in four patients. There were transient eosinophUia in 14%, and moderate Uver enzyme rises were observed in 25%. 

Fumaric acid esters are used to treat a variety of skin disorders, including psoriasis (1), cutaneous sarcoidosis (2), necrobiosis lipoidica diabeticorum (3), and disseminated granuloma annulare (4). 

Mrowietz U, Christophers E, Altmeyer P. Treatment of psoriasis with fumaric acid esters results of a prospective multicentre study. German Multicentre Study. Br J Dermatol 1998 138(3) 456-60. 

Hoefnagel JJ, Thio HB, Willemze R, Bouwes Bavinck JN. Long-term safety aspects of systemic therapy with fumaric acid esters in severe psoriasis. Br J Dermatol 2003 149(2) 363-9. 

Deegan AP, Kirby B, Rogers S, Grotty TB, McDonnell TJ. Organising pneumonia associated with fumaric acid ester treatment for psoriasis. Clin Respir J 2010 4(4) 248-51. 

Tumorigenicity Fumaric acid esters have been used in the treatment of psoriasis since 1959, after Schweckendiek s description. They induce a shift from the T-helper 1 (Th-1) cytokine response to a Th-2 cytokine response and subsequent lymphopenia with low CD3 and CD4 counts. Low CD4 counts reflect the degree of immunosuppression and, in organ transplant recipients increase the risk of skin cancers, such as squamous cell carcinoma [25 ]. 

Reich K, Thad D, Mrowietz U, Kamps A, Neureither M, Luger T (2009) Efficacy and safety of fumaric acid esters in the long-term treatment of psoriasis a retrospective study (FUTURE). J Dtsch Dermatol Ges 7(7) 603-611... 

The effect of systemically and/or topically administered fumaric acid monoethyl ester (ethyl fumarate) on psoriasis was studied by Dubiel and Happle (1972) in six patients. Two patients who had been treated with locally applied ointments consisting of 3% or 5% ethyl fumarate in petrolatum developed symptoms of renal toxicity. 

A very different application of fumaric acids is in a medicine to treat psoriasis (Reich et al. 2009). Long-term treatment of patients with moderate and severe psoriasis with fumaric acid dimethyl ester showed a good and sustained clinical efficacy combined with a favorable safety profile. The dimethyl ester is also promising in treatment of multiple sclerosis (Killestein et al. 2011). 

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