CYCLOSPORINE VERSUS ETRETINATE - ITALIAN MULTICENTER COMPARATIVE TRIAL IN SEVERE PLAQUE-FORM PSORIASIS

Seventy-six patients with severe diffuse plaque-form psoriasis and a b aseline PASI score greater-than-or-equal-to 18 were enrolled in a rand omized 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 th e withdrawal of therapy in the 54 patients achieving remission were ev aluated over the following 6 months (phase 2). Twelve of these patient s 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, laborato ry parameters and blood pressure were carefully monitored every week f or the first 3 months and then monthly. The only concomitant therapy a llowed 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 tre atment) was higher in the cyclosporin than in the etretinate group. Bo th the tolerability and safety of cyclosporin proved to be adequate fo r 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 t he medication because of an adverse reaction, as against 7/40 in the e tretinate group (1 case of inefficacy, 1 case of adverse reaction and 5 cases of non-compliance). Six months after the discontinuation of th e trial drugs, relapses occurred in 13/29 patients in the cyclosporin group and in 3/25 in the etretinate group; no 'rebound' was observed i n any of the relapsing patients. Long-term cyclosporin treatment was b oth efficacious and well tolerated. In conclusion, cyclosporin at dose s of 2.5-5 mg/kg/day administered to reliable, carefully selected pati ents closely monitored in terms of both clinical and laboratory parame ters currently produces the quickest and more constantly favourable re sults in patients with severe psoriasis.