A randomized trial of methotrexate versus azathioprine for severe atopic eczema

The Journal of Allergy and Clinical Immunology, 04/26/2011

Schram ME et al. - Both treatments achieved clinically relevant improvement and were safe in the short term. Methotrexate and azathioprine are appropriate options for the treatment of severe atopic eczema.


  • Patients with severe atopic eczema were randomly assigned in a 1:1 ratio to receive either methotrexate (dosage, 10-22.5 mg/wk) or azathioprine (dosage, 1.5-2.5 mg/kg/d) for 12 weeks, followed by a 12-week follow-up period.
  • Primary outcome was the mean change in the severity scoring of atopic dermatitis index after 12 weeks.
  • Efficacy assessors blinded for allocation of treatment were used to perform clinical outcome assessment.
  • Analyses were done on an intention-to-treat basis.


  • Of the 45 patients screened, 42 were included.
  • At week 12, patients in the methotrexate group had a mean relative reduction in the severity scoring of atopic dermatitis index of 42% (SD, 18%) compared with 39% (SD, 25%) in the azathioprine group (P = .52).
  • Proportions of patients achieving at least mild disease and reductions on impact of quality of life, symptoms, and levels of thymus and activation-regulated chemokine were similar in both groups at weeks 12 and 24.
  • No statistically significant differences were found in the number and severity of adverse events.
  • Abnormalities in blood count were more common in the azathioprine group.
  • No serious adverse events occurred.

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