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Long-term methotrexate therapy effectively treated juvenile localized scleroderma

Long-term methotrexate therapy was a beneficial, well-tolerated treatment for juvenile localized scleroderma, according to study results.

Researchers in Italy evaluated 65 patients with juvenile localized scleroderma (JLS; or morphea) previously enrolled in a double blind, randomized control trial and treated for the first 3 months with oral methotrexate (MTX; 15 mg/m2 weekly) and prednisone (1 mg/kg daily, maximum 50 mg). Clinical evaluation, infrared thermography and computerized skin scores were used to evaluate lesions.

Patients were defined as responders if they satisfied criteria including no new lesions, skin score rate less than 1 and a decrease in lesion temperature by at least 10% compared with baseline. Maintaining responder status after stopping treatment for at least 6 months was classified as clinical remission (CR), and response maintained while taking MTX for at least 6 months defined CR on medication (CRM).

Fifty-eight patients (mean age, 9.4 years; 72.4% female) were followed up during a mean of 40.3 months; seven were lost to follow-up. Forty-eight patients were responders at the last follow-up, while 10 patients relapsed within 24 months of MTX initiation. Responders were evaluated every 3 to 4 months during a mean of 43 months. Thirty-five responders received MTX for a mean of 27.5 months and then maintained CR for 25.6 months or longer without MTX. Thirteen other responders were in CRM. Twenty-eight patients experienced mild MTX-related side effects, including nausea and headache, but maintained treatment.

Researchers cited difficulty in comparing data to previous studies because objective measures such as infrared thermography and computerized skin score were unavailable.

“Long-term maintenance MTX treatment is beneficial for localized scleroderma (morphea) in young patients and is generally well tolerated with rare occurrence of significant adverse events,” the researchers concluded. “We recommend an initial 3 months of combined MTX-corticosteroid therapy and MTX treatment duration of at least 24 months to ensure a prolonged and sustained disease remission for the majority of the patients.”