Although
cyclosporin is effective in immunosuppression following
organ transplantation and in the treatment of
psoriasis, its use is limited by its side-effects, notably impaired renal function and
hypertension. As
SDZ IMM 125, a new derivative of the
cyclosporin family, showed considerable immunosuppressive activity in experimental studies, with less effect on renal function, it was considered a potential successor to
cyclosporin for both indications. In this multicentre, double-blind, placebo-controlled study, the efficacy and tolerability of 40, 100, 200 and 400 mg
SDZ IMM 125 daily were studied in 59 patients with
psoriasis. Patients were followed for a period of 5 weeks (4 weeks treatment, and 1 week post-treatment observation). A dose-dependent effect of
SDZ IMM 125 was observed. A significant correlation was found between the dose of
SDZ IMM 125 and changes in the sum of severity scores of three
indicator plaques. There was a significant decrease in the body surface area affected by
psoriasis in the 400-mg group (P < or = 0.01), whereas a decrease of the global
psoriasis severity was observed in the 200-mg (P < or = 0.01) and the 400-mg groups (P < or = 0.001). No serious adverse events occurred during the 4 weeks of treatment. Three patients discontinued treatment because of adverse events (one
sore throat, two
influenza). Clinical adverse events were similar to those reported with
cyclosporin, the most frequent being gastrointestinal disturbances. Estimation of renal function indices showed that increases from baseline values were dose-dependent, and appeared to be similar to those seen with
cyclosporin.(ABSTRACT TRUNCATED AT 250 WORDS)