Double-blind placebo-controlled study of long-term low-dose cyclosporin inthe treatment of palmoplantar pustulosis

We previously showed in a double-blind, placebo-controlled study that cyclo sporin at a dose of 2.5 mg/kg per day is an effective treatment for palmopl antar pustulosis (PPP). In the present randomized, double-blind, placebo-co ntrolled multicentre study we treated 58 PPP patients with placebo or cyclo sporin at an initial dose of 1 mg/kg per day. Disease activity was calculat ed from the number of fresh pustules, Treatment success was defined as the number of fresh pustules not exceeding 50% of the patients' own baseline pu stule number, In cases of treatment success the dose of the test medication was not increased and the treatment was kept blinded for a maximum of 12 m onths. Blinding was broken only on treatment failure of the initial test me dication dose. The mean blinded treatment time was 5.1 months for the patie nts receiving cyclosporin and 2.1 months for placebo (P<0.01). Treatment wa s kept blinded for 12 months for seven patients in the cyclosporin and two in the placebo group (P < 0.05). Patients whose treatment code was broken c ontinued in an open dose-finding part of the study with dose adjustments of cyclosporin every second month. In cases of treatment failure the dose of cyclosporin was increased in steps of 1 mg/kg per day; in cases of treatmen t success the cyclosporin dose was decreased by 1 mg/kg per day. The minimu m and maximum doses were 1 and 4 mg/kg per day, respectively, The mean effe ctive dose during the dose-finding part was between 1.2 and 1.7 mg/kg per d ay. Two patients did not respond to the highest dose of 4 mg/kg per day. In two patients serum creatinine levels increased by > 30% of their own basel ine. The other main adverse events were hypertension (seven patients) and h ypertrichosis (six patients), After stopping cyclosporin treatment the mean number of fresh pustules showed a maximum after 2 weeks with a continuous decline after that. Twelve months after completing the treatment the mean n umber of pustules was reduced to 20.0 compared with 63.6 at baseline (P<0.0 01); 11 patients were free from pustules and two of these were totally clea red. We conclude that cyclosporin at 1-2 mg/kg per day is an effective and well tolerated treatment for PPP in most patients.