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Oral pimecrolimus in the treatment of moderate to severe chronic plaque‐type psoriasis: a double‐blind, multicentre, randomized, dose‐finding trial
Author(s) -
Gottlieb A.B.,
Griffiths C.E.M.,
Ho V.C.,
Lahfa M.,
Mrowietz U.,
Murrell D.F.,
Ortonne JP.,
Todd G.,
Cherill R.,
Marks I.,
EmadyAzar S.,
Paul C.F.
Publication year - 2005
Publication title -
british journal of dermatology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.304
H-Index - 179
eISSN - 1365-2133
pISSN - 0007-0963
DOI - 10.1111/j.1365-2133.2005.06661.x
Subject(s) - pimecrolimus , psoriasis , psoriasis area and severity index , medicine , adverse effect , placebo , randomized controlled trial , calcineurin , clinical endpoint , erythema , dermatology , gastroenterology , transplantation , pathology , alternative medicine
Summary 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.