Low-dose (1.25 mg/kg) cyclosporin A: treatment of psoriasis and investigation of the influence on lipid profile.
This study was designed to investigate the therapeutical efficacy of a comparatively low dose cyclosporin A (1.25 mg/kg/day) in the treatment of psoriasis and to assess the influence of cyclosporin A on lipid profiles. In the first, double-blind part of the study, 133 patients with moderate to severe psoriasis were randomized to receive a daily dose of 1.25 or 2.5 mg cyclosporin A/kg or placebo for a period of 10 weeks (period I). Subsequently, the patients entered a second open-label 12-week study (period II), in which the dosage could be increased up to 5.0 mg/kg/day. This was followed by a period of 4 weeks without treatment. After 10 weeks the percentage improvement from baseline in the Psoriasis Area and Severity Index (PASI) was 5.9% on placebo, 27.2% on 1.25 mg/kg/day and 51.0% on 2.5 mg/kg/day cyclosporin A. The final average dose at the end of study period II was 2.99 mg cyclosporin A/kg/day. At this time the PASI was reduced by at least 75% in 63.0% of the patients. From this group of good responders no patient relapsed (PASI > 50% of baseline) during the four weeks after termination of active treatment. No significant effects of the drug on the lipid profiles were detected. We conclude that 1.25 mg cyclosporin A/kg/day is superior to placebo in the treatment of psoriasis vulgaris and that a dose reduction to 1.25 mg/kg/day should be considered in patients responding well to a conventional dose between 2.5 and 5.0 cyclosporin A/kg/day.
Meffert
H
H
Department of Dermatology, Humboldt-Universität, Charité, Berlin, Germany.
Bräutigam
M
M
Färber
L
L
Weidinger
G
G
D000293:Adolescent; D000328:Adult; D000368:Aged; D002784:Cholesterol / Q000097:blood; D016572:Cyclosporine / Q000008:administration & dosage / Q000627:therapeutic use*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D008055:Lipids / Q000097:blood*; D008297:Male; D008875:Middle Aged; D011565:Psoriasis / Q000097:blood* / Q000175:diagnosis / Q000188:drug therapy*; D012720:Severity of Illness Index; D016896:Treatment Outcome; D014280:Triglycerides / Q000097:blood
D007166:Immunosuppressive Agents; D008055:Lipids; D014280:Triglycerides; D016572:Cyclosporine; D002784:Cholesterol