Objective: To determine the efficacy, tolerability, and steroid sparing effect of methotrexate (MTX) in patients with systemic lupus erythematosus (SLE) in clinical practice.
Methods: From a database of 467 patients, we identified all patients with SLE and undifferentiated connective tissue disease (UCTD, 2-3 criteria for SLE) who had received MTX. Details of previous therapy, indications for MTX, efficacy, toxicity, and steroid reduction during MTX therapy were recorded.
Results: 21 patients with SLE who had been treated with MTX were identified. The mean weekly MTX dose rose from 7.5 mg at initiation to 13.6 mg at 6 mo and 17.1 mg at 12 mo. A response was seen in 12 of 21 patients, and 7 patients had a sustained 50% reduction in disease activity at the final evaluation. Response was best in patients with dermatitis (5/6), arthritis (6/13), and myositis (1/1), but minimal in patients with central nervous system dysfunction (1/4), serositis (1/3), and isolated fatigue (0/1). Toxicity was noted in 62% of patients, but only 33% discontinued due to toxicity. MTX was continued in 74% of patients at 6 mo and 40% at 12 mo. Steroid dosage was reduced to half the original dose in 9 of 16 patients. A similar pattern of MTX efficacy and toxicity was observed in 15 patients with UCTD.
Conclusion: MTX is useful in the treatment of some patients with mild manifestations of SLE, with an acceptable toxicity profile, but only modest steroid sparing potential. Patients with dermatitis and arthritis appear to have the best chance of responding to MTX therapy.