NEW YORK (Reuters Health) – Methotrexate and azathioprine are similarly effective as systemic treatments for severe atopic dermatitis in adults, according to the results of a head-to-head trial conducted in Europe.
Cyclosporine and systemic corticosteroids are frequently used to treat severe eczema in adults, but both have drawbacks, the investigators point out in the Journal of Allergy and Clinical Immunology online April 25.
Noting that inexpensive disease-modifying antirheumatic drugs seem to be beneficial for atopic eczema, Dr. Mandy Elvira Schram, with the Academic Medical Center of the University of Amsterdam, the Netherlands, and colleagues conducted a comparison trial of off-label methotrexate versus azathioprine in 42 patients with severe atopic eczema.
The participants’ mean age was 40, mean duration of eczema was 36 years, and all were unresponsive or intolerant to cyclosporine.
They were randomly assigned to receive methotrexate starting at 10 mg/week and titrated up to 22.5 mg/week, or azathioprine beginning at 1.5 mg/kg daily and escalated up to a maximum of 2.5 mg/kg daily, for 12 weeks. This was followed by another 12-week period in which dosages were reduced in responders in order to find the optimum dosage.
The severity of eczema based on the SCORAD score declined over the first 12 weeks by 42%, from 57.2 to 34.4, in the methotrexate group. In the azathioprine group the severity score fell from 58.0 to 36.3, a relative reduction of 39%, the researchers report.
Fifteen patients in each group had an improvement to at least “mild” disease, according to the report. Quality of life, based on the Skindex-17 score, improved by 26% in the methotrexate group and 20% in the azathioprine group.
No severe or serious adverse events occurred, the authors note. Statistically significant changes in blood count were more common with azathioprine, while rates of infections, gastrointestinal complaints, and increased liver enzymes were similar in both groups.
During the second 12-week period, 95% of patients in the methotrexate group and 84% of the azathioprine group continued on their treatment. After 24 weeks, the mean SCORAD scores were 30.4 in the methotrexate group and 33.7 in the azathioprine, representing a relative reduction from baseline of 48% versus 43%, Dr. Schram and colleagues found.
They conclude, “Methotrexate and azathioprine can be considered equally effective for the treatment of severe atopic eczema in adults.”
They add, “Overall, this study is limited to conclusions about the safety for medium- to long-term use. Nevertheless, because both drugs have been available for more than 50 years, they have a well-known toxicity profile, and dermatologists are familiar with the use of these drugs in the treatment of psoriasis or bullous diseases.”
A randomized trial of methotrexate versus azathioprine for severe atopic eczema
J Allergy Clin Immunol 2011