Assessing Safety, Efficacy of Methotrexate for Atopic Dermatitis

Treatment with methotrexate 25 mg/week is associated with a significant improvement in symptoms of moderate to severe atopic dermatitis (AD) at 20 weeks compared with cyclosporine, according to the results of a study published in the Journal of Allergy and Clinical Immunology: In Practice.

A total of 97 patients with moderate to severe AD were randomly assigned to receive treatment with either oral methotrexate 15 mg/week (n=50) or cyclosporine 2.5 mg/kg/day (n=47) for 8 weeks. All patients were examined by a dermatologist at enrollment and baseline visits, then every 4 weeks over 24 weeks of the study. The primary end point was achievement of 50% improvement in the SCORing Atopic Dermatitis [SCORAD] index at week 8. Secondary end points included achieving a 50% improvement in the Eczema Area Severity Intensity (EASI 50) index and a Dermatology Life Quality Index (DLQI) value of ≤5 at 8 weeks.

Median disease duration was ≥23 years for patients in both arms of the study. Severe disease (based on a SCORAD index >40) was present in ≥80% of patients. During the study period, there were dropouts in both groups, resulting in 23 patients in the methotrexate group and 31 in the cyclosporine group being evaluated at week 24.

At week 8, methotrexate was inferior to cyclosporine, with 8% of patients in the methotrexate arm and 42% of those in the cyclosporine arm achieving a SCORAD 50 response. When the primary end point was not met at week 8, the methotrexate dose was increased to 25 mg (56% of patients) and the cyclosporine dose was increased to 5 mg (49% of patients) for the next 16 weeks.

EASI 50, the noninferiority end point, was reached at week 20 in 92% of patients in the methotrexate arm vs 87% of those in the cyclosporine arm. Treatment-related adverse events occurred significantly more often with cyclosporine therapy (P <.0001). 

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The results indicate that methotrexate 15 mg/week is inferior to cyclosporine 2.5 mg/kg/day in improving moderate to severe symptoms of AD. “However, increasing the dose of methotrexate to 25 mg/week yielded significant improvement in atopic dermatitis symptoms at week 20 comparable to that observed with cyclosporine and with a better safety profile,” the researchers concluded.


Goujon C, Viguier M, Staumont-Sallé D, et al. Methotrexate versus cyclosporine in adults with moderate-to-severe atopic dermatitis: a phase III randomized noninferiority trial [published online September 26, 2017]. J Allergy Clin Immunol Pract. doi: 10.1016/j.jaip.2017.07.007