THE LONG-TERM SAFETY AND EFFICACY OF CYCLOSPORINE IN SEVERE REFRACTORY ATOPIC-DERMATITIS - A COMPARISON OF 2 DOSAGE REGIMENS

An open, randomized trial was performed to determine the optimal dosag e schedule with regard to the efficacy and safety of cyclosporin in se vere atopic dermatitis. The study also provided clinical experience wi th regard to the efficacy and safety of long-term cyclosporin treatmen t. During a 2-month dose-finding period, 78 patients with severe, long -standing atopic dermatitis received cyclosporin at a dose of either 5 mg/kg per day, decreasing to 3 mg/kg per day (Group A), or 3 mg/kg pe r day, increasing to 5 mg/kg per day (Group B). Patients were maintain ed on their optimal dose for a further 10 months, Patients in Group A showed a significantly greater improvement in efficacy parameters over the first 2 weeks than with patients in Group B, but as the dose was decreased in Group A and increased in Group B, these differences were minimized, After 1 year, cyclosporin showed an efficacy of 59.8% in Gr oup A and 51.7% in Group B, assessed by a severity score, Assessed in terms of an area score, these figures were 48.7% and 40%, respectively . Cyclosporin demonstrated a good safety profile during long-term trea tment and was generally well tolerated. The lower starting dosage was not associated with higher dropout rates, This study showed no differe nces in efficacy or adverse events between the two dosage schedules in long-term treatment.