| Autor: |
Gottlieb, A. B., Griffiths, C. E. M., Ho, V. C., Lahfa, M., Mrowietz, U., Murrell, D. F., Ortonne, J.-P., Todd, G., Cherill, R., Marks, I., Emady-Azar, S., Paul, C. F. |
| Předmět: |
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| Zdroj: |
British Journal of Dermatology; Jun2005, Vol. 152 Issue 6, p1219-1227, 9p |
| Abstrakt: |
There is a need for safe and effective alternative treatments for patients with moderate to severe psoriasis.Pimecrolimus is a calcineurin inhibitor that is being investigated in oral form for the treatment of psoriasis.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.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.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. [ABSTRACT FROM AUTHOR] |
| Databáze: |
Complementary Index |
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