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Previous Volume 349:658-665 August 14, 2003 Number 7 Next

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ABSTRACT

Background Methotrexate and cyclosporine are well-known systemic therapies for moderate-to-severe chronic plaque psoriasis. We conduced a randomized, controlled trial comparing methotrexate and cyclosporine in terms of effectiveness, side effects, and the quality of life.

Methods A total of 88 patients with moderate-to-severe psoriasis were randomly assigned to treatment for 16 weeks with either methotrexate (44 patients; initial dose, 15 mg per week) or cyclosporine (44 patients; initial dose, 3 mg per kilogram of body weight per day) and were followed for another 36 weeks. The primary outcome was the difference between groups in the psoriasis area-and-severity index after 16 weeks of treatment, after adjustment for base-line values; scores were determined in a blinded fashion by trained observers.

Results Two patients were excluded from the analysis after randomization because they were found to be ineligible, and one patient withdrew his consent. Twelve patients in the methotrexate group had to discontinue treatment because of reversible elevations in liver-enzyme levels, and 1 patient in the cyclosporine group had to do so because of an elevation in the bilirubin level, but all 13 were included in the analysis. After 16 weeks of treatment, the mean (±SE) score for the psoriasis area-and-severity index decreased from 13.4±3.6 at base line to 5.0±0.7 among 43 patients treated with methotrexate, whereas the score decreased from 14.0±6.6 to 3.8±0.5 among 42 patients treated with cyclosporine. After adjustment for base-line values, the mean absolute difference in values at 16 weeks was 1.3 (95 percent confidence interval, –0.2 to 2.8; P=0.09). The physician's global assessment of the extent of psoriasis, the time to and the rates of remission, and the quality of life were similar in the two groups.

Conclusions No significant differences in efficacy were found between methotrexate and cyclosporine for the treatment of moderate-to-severe psoriasis.

Source Information

From the Departments of Dermatology (V.M.R.H., P.I.S., W.F.M.G., J.D.B., M.A.R.) and Clinical Epidemiology and Biostatistics (B.C.O., C.A.J.M.B., J.B.R., P.M.M.B.), Academic Medical Center, University of Amsterdam, Amsterdam.

Address reprint requests to Dr. de Rie at the Department of Dermatology, Rm. A0-222, Academic Medical Center, University of Amsterdam, P.O. Box 22700, 1100 DE Amsterdam, the Netherlands.

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