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Strong Medicine: Methotrexate and Azathioprine Equally Safe and Effective for Atopic Dermatitis

Both treatments produced substantial improvement for patients with severe disease.

Sometimes topical therapies do not control atopic dermatitis (AD), and physicians prescribe antimetabolites or immunosuppressive agents. To determine whether azathioprine works better than methotrexate, investigators conducted a single-blind, randomized, 12-week trial comparing efficacy, safety, and change in quality of life with the two systemic treatments. All 43 study patients (age >18; mean age, 40) had severe AD (mean Scoring Atopic Dermatitis [SCORAD] score, 58; mean Skindex-17 quality-of-life score, 51). Twenty patients received methotrexate (mean dose, 20 mg once weekly), and 23 received azathioprine (mean dose, 2.2 mg/kg/day); concomitant topical treatment was permitted.

No statistical differences between methotrexate and azathioprine were observed for any parameter. SCORAD scores fell in a roughly parallel linear fashion throughout the 12 weeks: For both drugs at 6 weeks, score improvements were about half of the total. After 12 weeks, mean relative reductions in SCORAD score were 42% with methotrexate and 39% with azathioprine. Neither treatment was superior, and both were effective (there was no placebo group). Investigators rated 75% of methotrexate recipients and 68% of the azathioprine recipients as globally cleared or as having minimal or mild disease. The methotrexate group was using almost twice as much topical steroid cream as the azathioprine group at the study endpoint.

Many subjects continued treatment after 12 weeks, with little further improvement. More azathioprine-treated patients developed lymphocytopenias. No subjects experienced severe infections or other serious or severe adverse events.

Comment: These results are in line with results of two previous studies showing that both azathioprine and methotrexate ameliorate severe atopic dermatitis. This study was powered to detect a fall in SCORAD scores of at least 8 points. A smaller decrease might be clinically meaningful but to be definitive would require more subjects. Both drugs work more slowly than prednisone or cyclosporine, requiring 8 to 12 weeks of treatment to reach maximum response.

— Mark V. Dahl, MD

Published in Journal Watch Dermatology August 26, 2011

Citation(s):

Schram ME et al. A randomized trial of methotrexate versus azathioprine for severe atopic eczema. J Allergy Clin Immunol 2011 Aug; 128:353.

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