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Methotrexate and Cyclosporine Show Similar Efficacy, Tolerability for Psoriasis
New England Journal of Medicine (NEJM)
08/14/2003
By Joene Hendry
The efficacy and tolerability of methotrexate and cyclosporine are similar for the treatment of moderate-to-severe psoriasis according to the findings of a randomised trial.
Menno A. de Rie, MD, PhD, of the University of Amsterdam, the Netherlands and colleagues treated patients with moderate-to severe plaque psoriasis with methotrexate (initial dose 15 mg per week) or cyclosporine (initial dose 3 mg/kg body weight per day) for 16 weeks. The patients, who had previous insufficient responses to topical or UVB therapy, or both, and had no previous treatment with either study medication, were followed for an additional 36 weeks to determine treatment efficacy and quality of life outcomes.
Overall, 94% of all patients achieved a 25% reduction from baseline in psoriasis area-and-severity index scores after 12 weeks of treatment. After 16 weeks of treatment the relative reduction from baseline in the psoriasis area-and-severity index scores was 64% in the methotrexate group and 73% in the cyclosporine group.
Among the 43 patients (mean age 41.6 years) undergoing 16 weeks of methotrexate treatment, 17 achieved almost complete remission, defined as a reduction in the baseline score for psoriasis area-and-severity index of more than 90%. Side effects were reported by 29 patients treated with methotrexate and of these 19 patients reported nausea.
Among the 42 patients (mean age 38.3 years) treated with 16 weeks of cyclosporine, 14 achieved almost complete remission. Side effects were reported by 35 of the cyclosporine treated patients with 18 patients reporting headaches, 12 reporting muscle ache, and 14 reporting paraesthesia in the fingertips and toes.
The researchers report no significant differences between groups in physician's global assessments, the duration of remission after cessation of oral treatments, or in quality of life subscales after 16 weeks of treatment.
"We demonstrated that the effectiveness and tolerability of methotrexate are similar to those of cyclosporine in patients with moderate-to-severe psoriasis," the authors write. They add that treatment decisions for individual patients can be guided by the differences between medications in side effects, ease of administration, and costs.
N Engl J Med 2003;349:658-65.
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