CYCLOSPORINE AS MAINTENANCE THERAPY IN PATIENTS WITH SEVERE PSORIASIS

Background: Low-dose cyclosporine therapy for severe plaque psoriasis is effective. Most side effects can be controlled by patient monitorin g, with appropriate dose adjustment or pharmacologic intervention, or both, if indicated. Prevention or reversibility of laboratory and chem ical abnormalities may be achieved by discontinuation of therapy after the induction of clearing. However, relapse occurs rapidly on discont inuation. Maintenance therapy with cyclosporine after induction has no t been fully evaluated. Objective: Our purpose was to compare a regime n of 3.0 mg/kg per day of oral cyclosporine with placebo in maintainin g remission or improvement in patients with psoriasis. Methods: After a 16-week unblinded induction phase in which 181 patients received cyc losporine, 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-we ek maintenance phase and were randomly assigned to either placebo, cyc losporine, 1.5 mg/kg per day, or cyclosporine, 3.0 mg/kg per day. Pati ents were considered to have had a relapse when BSA returned to 50% or more of the prestudy baseline value. Clinical efficacy, adverse effec ts, and laboratory values were monitored regularly throughout both stu dy phases. Results: During induction, cyclosporine at approximately 5. 0 mg/kg per day produced a re reduction in BSA of 70% or more in 86% o f the patients. During maintenance, the median time to relapse was 6 w eeks in both the placebo and cyclosporine 1.5 mg/kg per day groups, bu t was longer than the 24-week maintenance period in the 3.0 mg/kg per day group (p <0.001 vs placebo). By the end of the maintenance period, 42% of the patients in the 3.0 mg/kg per day cyclosporine group had a relapse compared with 84% in the placebo group. Changes in laboratory values associated with the higher induction dosage generally exhibite d partial or complete return toward mean prestudy baseline values duri ng the maintenance phase, with the greatest degree of normalization in the placebo group. Conclusion: Cyclosporine, 3.0 mg/kg per day, adequ ately and safely maintained 58% of patients with psoriasis for a 6-mon th period after clearing of their psoriasis with doses of approximatel y 5.0 mg/kg per day.