Evaluation of oral methotrexate in the treatment of systemic sclerosis.

BACKGROUND: Treatment of scleroderma is difficult and currently no treatment can induce complete remission of the disease.
OBJECTIVE: To evaluate weekly oral methotrexate in the treatment of Indian patients with systemic sclerosis.
METHODS: Thirty-three patients with systemic sclerosis presenting to the department of dermatology (outpatients) who satisfied the inclusion criteria were enrolled into the study. All cases were admitted into the dermatology ward for detailed evaluation. A detailed history and physical examination, including assessment of disease severity by Rodnan skin scoring, was carried out. Baseline investigations included complete blood counts, blood glucose, serum electrolytes, renal function test, liver function tests, urine examination (albumin, sugar, microscopic examination, 24-h protein), ANA, chest X-ray, Barium swallow, pulmonary function test, electrocardiogram (ECG), HRCT of chest, and 4-mm punch skin biopsy from dorsum of the hand. All the patients were treated with oral methotrexate (15 mg/week) for 6 months, following standard guidelines.
RESULTS: The patients included 29 (87.9%) females and four (12.1%) males with a mean age of 31.45 +/- 8.76 years. The mean duration of disease was 5.6 +/- 4.5 years (range 2 months to 15 years). All the patients had binding down of skin, 31 (93.9%) had Raynaud's phenomenon, 31 (93.9%) had pigmentary change, 21 (63.6%) had hand contractures, 17 (51.5%) had fingertip ulcers, 15 (45.5%) had dyspnoea, 14 (42.4%) had restricted mouth opening, 13 (39.4%) had telangiectasia, 11 (33.3%) had fingertip resorption, eight (24.2%) had joint complaints, six (18.2%) had dysphagia, and one (3.03%) had gangrene. On laboratory investigation ANA was positive in 29 (87.9%) patients, dsDNA was raised in only four (12.1%), baseline chest X-ray was abnormal in 18 (54.5%), HRCT was abnormal in 27 (81.8%), abnormal PFT in 32 (96.9%), abnormal ECG in five (15.2%), and barium swallow abnormality in 19 (57.5%) patients. Twenty-five patients completed the 6-month follow up. There was subjective improvement in binding down (80%), Raynaud's phenomenon (96%), fingertip ulceration (88.8%), hyperpigmentation (77.2%) and dyspnoea (45.5%). The objective parameters showed statistically significant improvement in mouth openingm, but improvement of skin score, lung function (chest radiograph, PFT, HRCT), and dysphagia was not significant at the 6-month follow up. In eight patients, treatment was continued for 1 year of methotrexate, which showed statistically significant improvement in skin score.
CONCLUSION: It was concluded that methotrexate for 6 months only provides subjective improvement, and further studies after 1 year of treatment with methotrexate are recommended.