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Twice‐daily versus Once‐daily Applications of Pimecrolimus Cream 1% for the Prevention of Disease Relapse in Pediatric Patients with Atopic Dermatitis
Author(s) -
RuerMulard Mireille,
Aberer Werner,
Gunstone Anthony,
Kekki OutiMaria,
Estebaranz Jose Luis López,
Vertruyen André,
Guettner Achim,
Hultsch Thomas
Publication year - 2009
Publication title -
pediatric dermatology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.542
H-Index - 73
eISSN - 1525-1470
pISSN - 0736-8046
DOI - 10.1111/j.1525-1470.2009.00981.x
Subject(s) - pimecrolimus , medicine , atopic dermatitis , randomized controlled trial , hazard ratio , clinical endpoint , adverse effect , discontinuation , tacrolimus , dermatology , pediatrics , confidence interval , transplantation
The aim of this study is to compare twice‐daily and once‐daily applications of pimecrolimus cream 1% for prevention of atopic dermatitis relapses in pediatric patients. This multicenter trial enrolled 300 outpatients aged 2 to 17 years, with mild‐to‐severe atopic dermatitis. The patients were initially treated with twice‐daily topical pimecrolimus until complete clearance or for up to 6 weeks (open‐label period). Those who achieved a decrease of at least 1 point in the Investigator’s Global Assessment score were then randomized to double‐blind treatment with pimecrolimus cream 1% either twice daily or once daily for up to 16 weeks. Study medication was discontinued during periods of disease remission (Investigator’s Global Assessment = 0). The primary efficacy end point of the double‐blind phase was disease relapse (worsening requiring topical corticosteroids or additional/alternative therapy and confirmed by Investigator’s Global Assessment score ≥ 3 and pruritus score ≥ 2). Of the 300 patients enrolled in the study, 268 were randomized to treatment with pimecrolimus cream 1% either twice daily or once daily ( n = 134 in each group). The relapse rate was lower in the twice‐daily dose group (9.9%) than that in the once‐daily dose group (14.7%), but analysis of the time to disease relapse, using a Cox proportional model to adjust for confounding variables, did not show a statistically significant difference between treatment arms (hazard ratio: 0.64; 95% CI: 0.31–1.30). Treatment of active atopic dermatitis lesions with pimecrolimus cream 1% twice daily, followed by the once‐daily dosing regimen, was sufficient to prevent subsequent atopic dermatitis relapses over 16 weeks in pediatric patients.