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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
Oral pimecrolimus in the treatment of moderate to severe chronic plaque-type psoriasis: A double-blind, multicentre, randomized, dose-finding trial
British Journal of Dermatology, Volume 152, No. 6, Year 2005
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Description
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.
Authors & Co-Authors
Gottlieb, Alice Bendix
United States, New Brunswick
Rutgers Robert Wood Johnson Medical School at new Brunswick
Griffiths, Christopher E. M.
United Kingdom, Manchester
The University of Manchester
Ho., Vincent C.Y.
Canada, Vancouver
The University of British Columbia
Lahfa, Mourad
France, Paris
Hôpital Saint-louis
Mrowietz, U.
Germany, Kiel
Universitätsklinikum Schleswig-holstein Campus Kiel
Murrell, D. F.
Australia, Sydney
Unsw Sydney
Ortonne, Jean Paul
France, Nice
Centre Hospitalier Universitaire de Nice, Hôpital L'archet
Todd, Gail
South Africa, Cape Town
University of Cape Town
Cherill, Robert J.
Switzerland, Basel
Novartis International ag
Marks, I.
Switzerland, Basel
Novartis International ag
Emady-Azar, S.
Switzerland, Basel
Novartis International ag
Paul, Carle F.
Switzerland, Basel
Novartis International ag
Statistics
Citations: 53
Authors: 12
Affiliations: 9
Identifiers
Doi:
10.1111/j.1365-2133.2005.06661.x
ISSN:
00070963
Research Areas
Disability
Health System And Policy