A combination of oral methotrexate and pulsed high-dose corticosteroids significantly improved the visible inflammation in 15 adults with severe localized scleroderma, wrote Alexander Kreuter, M.D., of Ruhr-University Bochum (Germany) and his colleagues.
In a prospective, nonrandomized pilot study, nine women and six men received a weekly oral methotrexate dose of 15 mg. They also received an intravenous methylprednisolone sodium succinate dose of 1,000 mg for 3 consecutive days each month.
Patients were treated for at least 6 months, and the mean treatment duration was 9.8 months (Arch. Dermatol. 2005; 141:847–52). The two treatments have shown effectiveness against severe localized scleroderma when used separately, the researchers noted.
On average, the modified skin scores of the patients dropped significantly, from 10.9 to 5.5, and signs of improvement were visible after 2 months. In addition, the visual analog scores (VAS) for tightness improved in 12 patients. On average, the VAS for tightness decreased significantly, from 65.3 to 27.5.
Follow-up visits occurred every 4 weeks, and a modified skin score was used to assess skin involvement. Ultrasonography was performed at the end of the study to confirm the clinical improvement, and it showed a significant decrease in skin thickness between baseline and the study's end.
The patients also demonstrated significant increases in dermal density at the end of the study, and the dermal collagen structure had returned to normal or near normal levels.
The patients' ages ranged from 18 to 73 years, and the duration of illness ranged from 1 to 36 years. Prior to the study, 11 patients had been treated unsuccessfully with other methods.
Adverse effects included mild nausea and headache in three patients, diabetes mellitus in two patients, and weight gain in one patient, but these effects normalized after treatment ended. None of the patients showed signs of relapse over 6 months of follow-up.
Although the study was limited by its small size and lack of placebo controls, the favorable response and moderate side effects suggest that combination therapy for localized scleroderma merits further study and that the treatment may be effective in less severe cases as well.