title: Safety and efficacy of a fixed-dose cyclosporin microemulsion (100 mg) for the treatment of psoriasis.
abstract: Cyclosporin is a second-line modality for the treatment of psoriasis. The long-term efficacy of cyclosporin and potential adverse side-effects, however, are a concern to patients. Therefore, a cyclosporin microemulsion (Neoral), which is steadily absorbed at an ultra-low dosage (1-2 mg/kg per day) or low dosage (2-3 mg/kg per day), is currently recommended. The dose must be calculated based on patient bodyweight and the blood concentration monitored regularly, which is time-consuming. Furthermore, the concentration is related to the safety profile, but not to efficacy. We examined whether a fixed-dose cyclosporin microemulsion (100 mg/day) is effective for treating psoriasis. Enrolled patients (n = 40) were given either 100 mg cyclosporin emulsion once daily (group A) or 50 mg twice daily (group B), regardless of patient weight and condition, before meals in a randomized controlled study. Patient bodyweight ranged 50-80 kg. We assessed the serum cyclosporin concentration 1 h after administrating the medicine (C1 score), Psoriasis Area and Severity Index (PASI) score, quality of life, and the results of regular blood examinations. The improvement rate was 69.4 ± 4.8% in group A and 73.4 ± 4.3% in group B. PASI-50 was achieved by 82% in group A and 84% in group B. At 6 weeks, the number of patients with PASI-50 was significantly higher in group A than in group B. PASI-75 and -90 were also achieved in both groups with no significant difference between groups. Administration of a fixed-dose cyclosporin microemulsion (100 mg/day) is practical for second-line psoriasis treatment.
authors.affiliation: Department of Geriatric and Environmental Dermatology, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan. ysh1@yahoo.co.jp
authors.forename: Yoichi
authors.initials: Y
authors.lastname: Shintani
authors.forename: Natumi
authors.initials: N
authors.lastname: Kaneko
authors.forename: Takuya
authors.initials: T
authors.lastname: Furuhashi
authors.forename: Chiyo
authors.initials: C
authors.lastname: Saito
authors.forename: Akimichi
authors.initials: A
authors.lastname: Morita
mesh_terms: D000328:Adult; D016572:Cyclosporine / Q000008:administration & dosage* / Q000009:adverse effects / Q000097:blood; D016903:Drug Monitoring; D064420:Drug-Related Side Effects and Adverse Reactions; D004655:Emulsions; D005260:Female; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000097:blood; D008297:Male; D008875:Middle Aged; D011565:Psoriasis / Q000097:blood / Q000188:drug therapy*; D011788:Quality of Life; D016896:Treatment Outcome
chemical_list: D004655:Emulsions; D007166:Immunosuppressive Agents; D016572:Cyclosporine