Cyclosporin versus etretinate: Italian multicenter comparative trial in severe plaque-form psoriasis. Italian Multicenter Study Group on Cyclosporin in Psoriasis

Abstract

Seventy-six patients with severe diffuse plaque-form psoriasis and a baseline PASI score > or = 18 were enrolled in a randomized open study comparing cyclosporin 5 mg/kg/day (36 patients) with etretinate 0.75 reduced to 0.5 mg/kg/day (40 patients) over a period of 3 months (phase 1). The rate, severity and time to relapse after the withdrawal of therapy in the 54 patients achieving remission were evaluated over the following 6 months (phase 2). Twelve of these patients entered an open, uncontrolled phase aimed at defining the safety and the strategy of cyclosporin 2.5-5 mg/kg/day maintenance therapy over a further period of 9 months (phase 3). Patient tolerability, laboratory parameters and blood pressure were carefully monitored every week for the first 3 months and then monthly. The only concomitant therapy allowed was white petrolatum. Not only the number (35/36 vs. 29/40) but also the speed of remission (20/36 vs. 1/40 at the fourth week of treatment) was higher in the cyclosporin than in the etretinate group. Both the tolerability and safety of cyclosporin proved to be adequate for short-term treatment, all altered clinical or laboratory parameters being completely reversible after the withdrawal of therapy. Only 1 of the 36 patients in the cyclosporin group prematurely stopped taking the medication because of an adverse reaction, as against 7/40 in the etretinate group (1 case of inefficacy, 1 case of adverse reaction and 5 cases of non-compliance). Six months after the discontinuation of the trial drugs, relapses occurred in 13/29 patients in the cyclosporin group and in 3/25 in the etretinate group; no 'rebound' was observed in any of the relapsing patients. Long-term cyclosporin treatment was both efficacious and well tolerated. In conclusion, cyclosporin at doses of 2.5-5 mg/kg/day administered to reliable, carefully selected patients closely monitored in terms of both clinical and laboratory parameters currently produces the quickest and more constantly favourable results in patients with severe psoriasis.