Cyclosporine as maintenance therapy in patients with severe psoriasis

作者：Jerome L. Shupack, Elizabeth Abel, Eugene A. Bauer, Marc D. Brown, Lynn A. Drake, Ruth K. Freinkel, Cynthia A. Guzzo, John Y. M. Koo, Norman S. Levine, Nicholas J. Lowe, Charles J. McDonald, David J. Margolis, Matthew J. Stiller, Bruce U. Wintroub, Carol Bainbridge, Sandra Evans, Susan Hilss, William Leonard Mietlowski, Christine M. Winslow, Jay E. Birnbaum · 发表于：Journal of the American Academy of Dermatology · 年份：1997 · DOI：10.1016/s0190-9622(97)80219-8 · 被引用次数：103 · 研究领域：Psoriasis: Treatment and Pathogenesis、Rheumatoid Arthritis Research and Therapies、Parkinson's Disease and Spinal Disorders

BACKGROUND: Low-dose cyclosporine therapy for severe plaque psoriasis is effective. Most side effects can be controlled by patient monitoring, with appropriate dose adjustment or pharmacologic intervention, or both, if indicated. Prevention or reversibility of laboratory and chemical abnormalities may be achieved by discontinuation of therapy after the induction of clearing. However, relapse occurs rapidly on discontinuation. Maintenance therapy with cyclosporine after induction has not been fully evaluated. OBJECTIVE: Our purpose was to compare a regimen of 3.0 mg/kg per day of oral cyclosporine with placebo in maintaining remission or improvement in patients with psoriasis. METHODS: After a 16-week unblinded induction phase in which 181 patients received cyclosporine, 5.0 mg/kg per day (an increase up to 6.0 mg/kg per day and a decrease to 3.0 mg/kg per day were allowed, if required, to achieve efficacy or tolerability, respectively), those patients showing a 70% decrease or more in involved body surface area (BSA) entered the 24-week maintenance phase and were randomly assigned to either placebo, cyclosporine, 1.5 mg/kg per day, or cyclosporine, 3.0 mg/kg per day. Patients were considered to have had a relapse when BSA returned to 50% or more of the prestudy baseline value. Clinical efficacy, adverse effects, and laboratory values were monitored regularly throughout both study phases. RESULTS: During induction, cyclosporine at approximately 5.0 mg/kg per day produced a red...