Safety and efficacy of a fixed-dose cyclosporin microemulsion (100 mg) for the treatment of psoriasis
Article first published online: 4 MAY 2011
© 2011 Japanese Dermatological Association
The Journal of Dermatology
Volume 38, Issue 10, pages 966–972, October 2011
How to Cite
SHINTANI, Y., KANEKO, N., FURUHASHI, T., SAITO, C. and MORITA, A. (2011), Safety and efficacy of a fixed-dose cyclosporin microemulsion (100 mg) for the treatment of psoriasis. The Journal of Dermatology, 38: 966–972. doi: 10.1111/j.1346-8138.2011.01228.x
- Issue published online: 26 SEP 2011
- Article first published online: 4 MAY 2011
- Received 11 May 2010; accepted 14 December 2010.
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.