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Safety and efficacy of a fixed‐dose cyclosporin microemulsion (100 mg) for the treatment of psoriasis
Author(s) -
SHINTANI Yoichi,
KANEKO Natumi,
FURUHASHI Takuya,
SAITO Chiyo,
MORITA Akimichi
Publication year - 2011
Publication title -
the journal of dermatology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.9
H-Index - 65
eISSN - 1346-8138
pISSN - 0385-2407
DOI - 10.1111/j.1346-8138.2011.01228.x
Subject(s) - medicine , psoriasis , adverse effect , group b , dosing , psoriasis area and severity index , gastroenterology , anesthesia , dermatology
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.