Combined treatment with methotrexate and prednisone in patients with total and universal alopecia areata

Abstract

Multicenter, randomized, double-blind study carried out in France from 2014 to 2016, in patients aged 18 to 70 years with chronic total and universal alopecia areata (with at least 6 months of evolution). Cases were included in which previous topical and systemic treatments failed, with the exception of methotrexate (MTX).

89 patients were included and two successive phases of 6 months each were carried out. In the first, patients were randomized to receive treatment with MTX 20-25 mg weekly versus MTX placebo. Those who had hair regrowth rates greater than 25% were maintained with the same treatment. Those with less than a 25% response were reassigned to MTX + prednisone (20 mg/d for 3 months and then 15 mg/d for 3 months) versus MTX + prednisone placebo. The total duration of the protocol was 12 months.

The patients were evaluated by four independent international experts. The primary objective was complete or almost complete response (CR), understood as hair recovery greater than 90% (SALT score < 10) at 6 months.

It was observed that MTX as monotherapy did not have sufficient efficacy. The combination with low doses of prednisone was more effective and achieved CR in up to 31% of patients.

Follow-up was documented for 7 patients who had achieved CR for 70.3 months; 5 of them maintained response with a SALT score between 40 and 0. Three patients discontinued treatment and 4 continued with an average dose of 8.7 mg of daily prednisone and 11.6 mg of MTX weekly.

Onset of response was observed at 3 months in patients on combination therapy, while there was a longer delay in those using MTX alone.

The authors point out that the response levels were comparable with those obtained in the study by King et al. with baricitinib.