Based on this relatively small pragmatic study, MTX and AZA seem to be effective and safe as maintenance treatments in moderate-to-severe AD up to 5 years. Few patients in both groups survive on their originally allocated drug although some discontinued because of controlled AD.
Long-term data of methotrexate (MTX) and azathioprine (AZA) in atopic dermatitis (AD) are lacking. Previously, we published the results of a randomized controlled trial of 42 adults with severe AD treated with MTX or AZA for 12 to 24 weeks. Both MTX and AZA induced significant reductions in SCORing Atopic Dermatitis (SCORAD) index at 12 and 24 weeks after baseline, without a significant difference between treatments. 1 To assess long-term efficacy and safety of MTX versus AZA, all 42 patients were asked to participate in an observational follow-up study to be evaluated 3 monthly for 2 years. After 12 weeks of treatment with MTX or AZA, treatments were continued, stopped, or switched, reflecting normal clinical practice. The same outcomes as in the original randomized controlled trial were investigated, which correspond to the 4 core outcome domains for AD suggested by the Harmonising Outcome Measures for Eczema initiative. Patients were scored by trained blinded investigators. One of the primary outcomes was the difference in mean absolute and relative change in SCORAD
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