Oral pimecrolimus in the treatment of moderate to severe chronic plaque-type psoriasis: A double-blind, multicentre, randomized, dose-finding trial

Alice B. Gottlieb, C. E M Griffiths, V. C. Ho, M. Lahfa, U. Mrowietz, D. F. Murrell, J. P. Ortonne, G. Todd, R. Cherill, I. Marks, S. Emady-Azar, C. F. Paul

    Research output: Contribution to journalArticlepeer-review

    Abstract

    Background: There is a need for safe and effective alternative treatments for patients with moderate to severe psoriasis. Objectives: Pimecrolimus is a calcineurin inhibitor that is being investigated in oral form for the treatment of psoriasis. Patients and methods A double-blind, randomized, parallel-group, dose-finding study was performed. Healthy adult outpatients with moderate to severe chronic plaque-type psoriasis (n = 143) were randomized to receive oral placebo or pimecrolimus 10 mg, 20 mg or 30 mg twice daily (b.d.) for 12 weeks. Main outcome measures: The Psoriasis Area and Severity Index (PASI) was used to assess clinical severity of psoriasis. Results were analysed at weeks 7 (primary endpoint) and 13. Safety was assessed by monitoring all adverse events, laboratory investigations (blood chemistry, urinalysis, haematology) and physical examinations. Results: The change from baseline in PASI at week 7 showed a dose-dependent effect. The differences between each of the two higher doses of pimecrolimus and placebo were statistically significant (P <0.001; ANOVA). The mean percentage decreases from baseline in PASI in the placebo group and pimecrolimus 10 mg, 20 mg and 30 mg b.d. groups at week 7 were 3.1%, 22.2%, 51.3% and 54.0%, respectively. Most adverse events were of mild or moderate severity. The only adverse event to show a dose-response relationship was a transient feeling of warmth. No clinically relevant effects on laboratory parameters were observed, and no increase in skin infection with pimecrolimus was seen. Conclusions: Oral pimecrolimus produces a dose-dependent reduction in psoriasis severity, with doses of 20 mg and 30 mg b.d. being the most effective and well tolerated. © 2005 British Association of Dermatologists.
    Original languageEnglish
    Pages (from-to)1219-1227
    Number of pages8
    JournalBritish Journal of Dermatology
    Volume152
    Issue number6
    DOIs
    Publication statusPublished - Jun 2005

    Keywords

    • Adults
    • Oral
    • Pimecrolimus
    • Plaque-type psoriasis
    • Randomized

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