In a recent clinical trial, a combination of methotrexate and low-dose prednisone led to complete hair regrowth (HR) in almost one-third of patients with alopecia areata totalis (AT) or universalis (AU).
The findings were published in JAMA Dermatology.
“Poor therapeutic results have been reported in patients with alopecia areata totalis or universalis, the most severe and disabling types of alopecia areata (AA),” the authors write.
They conducted this trial to see if methotrexate might be an inexpensive and effective treatment for these conditions.
The trial was conducted in eight dermatology departments at university hospitals between March 2014 and Dec. 2016. Adult patients (89) with AT (1) or AU (88) that had been evolving for more than six months despite previous topical and systemic treatments were included.
First, researchers randomized the patients to either receive methotrexate (25 mg per week) or a placebo for six months. Any patients with more than 25% HR at the six-month mark continued with that treatment until month 12. Patients who did not meet this HR mark were re-randomized to receive either methotrexate plus prednisone (20 mg per day for three months and 15 mg per day for three months) or methotrexate plus placebo of prednisone.
At month 12, the investigators observed complete or almost complete HR (Severity of Alopecia Tool (SALT) score <10) in one patient who received methotrexate alone and no patient in the placebo group. For the methotrexate plus prednisone group, 7 of 35 (20.0%; 95% CI, 8.4%-37.0%) patients achieved complete HR. This included five of 16 (31.2%; 95% CI, 11.0%-58.7%) who received methotrexate for 12 months and prednisone for six months.
The researchers observed a greater improvement in quality of life in patients who achieved a complete response compared with nonresponder patients. Two patients in the methotrexate group discontinued the study because of fatigue and nausea, which were observed in seven (6.9%) and 14 (13.7%) patients receiving methotrexate, respectively. No severe treatment adverse effect was observed.
“While methotrexate alone mainly allowed partial HR in patients with chronic AT or AU, its combination with low-dose prednisone allowed complete HR in up to 31% of patients,” the authors write. “These results seem to be of the same order of magnitude as those recently reported with JAK inhibitors, with a much lower cost.”