Hyun Sun Yoon1, Jai Il Youn. 1. Department of Dermatology, Seoul National University College of Medicine, Seoul, Korea.
Abstract
BACKGROUND: Few reports have been issued which compare the efficacy and tolerability of cyclosporine dose adjustments before 12 weeks of treatment. OBJECTIVE: To compare the efficacy and tolerability of two different dosage regimens of cyclosporine in severe psoriasis. METHODS: This 12-week, prospective, open-label study included 61 severe psoriasis patients. Patients were assigned to a 2.5 mg/kg per day starting dose and an increasing regimen ('standard regimen') or a 5.0 mg/kg per day starting dose and a decreasing regimen ('step-down regimen') group. The end point included 50% and 75% reductions in Psoriasis Area and Severity Index (PASI) scores. Adverse events were also evaluated. RESULTS: According to a 50% PASI reduction (PASI 50), the response rate at 12 weeks was similar for two groups. The percentage of patients achieving a 75% PASI reduction (PASI 75) at 12 weeks was higher in the step-down regimen group. The mean time to PASI 50 or PASI 75 was shorter in the step-down regimen group. No difference was found between the two groups in terms of the number of patients with adverse events requiring intervention. CONCLUSION: This study suggests that the 'step-down' cyclosporine regimen offers an effective and safe therapeutic option for the management of severe psoriasis.
RCT Entities:
BACKGROUND: Few reports have been issued which compare the efficacy and tolerability of cyclosporine dose adjustments before 12 weeks of treatment. OBJECTIVE: To compare the efficacy and tolerability of two different dosage regimens of cyclosporine in severe psoriasis. METHODS: This 12-week, prospective, open-label study included 61 severe psoriasispatients. Patients were assigned to a 2.5 mg/kg per day starting dose and an increasing regimen ('standard regimen') or a 5.0 mg/kg per day starting dose and a decreasing regimen ('step-down regimen') group. The end point included 50% and 75% reductions in Psoriasis Area and Severity Index (PASI) scores. Adverse events were also evaluated. RESULTS: According to a 50% PASI reduction (PASI 50), the response rate at 12 weeks was similar for two groups. The percentage of patients achieving a 75% PASI reduction (PASI 75) at 12 weeks was higher in the step-down regimen group. The mean time to PASI 50 or PASI 75 was shorter in the step-down regimen group. No difference was found between the two groups in terms of the number of patients with adverse events requiring intervention. CONCLUSION: This study suggests that the 'step-down' cyclosporine regimen offers an effective and safe therapeutic option for the management of severe psoriasis.