Methotrexate vs. ciclosporin in psoriasis: effectiveness, quality of life and safety. A randomized controlled trial

BACKGROUND: When this study was initiated, no previous studies comparing methotrexate and ciclosporin for moderate to severe plaque psoriasis had been performed. OBJECTIVES: To compare the effectiveness, quality of life and side-effects of methotrexate and ciclosporin treatments in a context reflecting normal clinical practice. METHODS: Eighty-four patients with moderate to severe plaque psoriasis were randomized to treatment with methotrexate or ciclosporin for 12 weeks. The primary outcome was the Psoriasis Area and Severity Index (PASI). The secondary outcome was quality of life, measured by the Dermatology Life Quality Index (DLQI) and the 36-item Short Form Health Survey (SF-36). A visual analogue scale (VAS) was used for patients' assessment. RESULTS: Sixty-eight patients started treatment and were included in the analysis. Dropout before initiation of treatment was higher in the ciclosporin group. Mean PASI change from baseline at 12 weeks was 58% in the methotrexate group and 72% in the ciclosporin group, showing ciclosporin to be more effective than methotrexate. Improvement of the VAS score was higher in the ciclosporin group. The methotrexate group showed a greater improvement in the subscale Physical Functioning of the SF-36. No significant difference between the groups was found for DLQI. CONCLUSIONS: Treatment with methotrexate or ciclosporin for chronic plaque psoriasis brings satisfactory disease control, improved quality of life and tolerable side-effects. A statistically significant difference in effectiveness between treatment groups was recorded, showing ciclosporin to be more effective than methotrexate in a short-term perspective.