Low-dose (1.25 mg/kg) cyclosporin A: treatment of psoriasis and investigation of the influence on lipid profile

Abstract

This study was designed to investigate the therapeutical efficacy of a comparatively low dose cyclosporin A (1.25 mg/kg/day) in the treatment of psoriasis and to assess the influence of cyclosporin A on lipid profiles. In the first, double-blind part of the study, 133 patients with moderate to severe psoriasis were randomized to receive a daily dose of 1.25 or 2.5 mg cyclosporin A/kg or placebo for a period of 10 weeks (period I). Subsequently, the patients entered a second open-label 12-week study (period II), in which the dosage could be increased up to 5.0 mg/kg/day. This was followed by a period of 4 weeks without treatment. After 10 weeks the percentage improvement from baseline in the Psoriasis Area and Severity Index (PASI) was 5.9% on placebo, 27.2% on 1.25 mg/kg/day and 51.0% on 2.5 mg/kg/day cyclosporin A. The final average dose at the end of study period II was 2.99 mg cyclosporin A/kg/day. At this time the PASI was reduced by at least 75% in 63.0% of the patients. From this group of good responders no patient relapsed (PASI > 50% of baseline) during the four weeks after termination of active treatment. No significant effects of the drug on the lipid profiles were detected. We conclude that 1.25 mg cyclosporin A/kg/day is superior to placebo in the treatment of psoriasis vulgaris and that a dose reduction to 1.25 mg/kg/day should be considered in patients responding well to a conventional dose between 2.5 and 5.0 cyclosporin A/kg/day.