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Effectiveness and safety of a prevention‐of‐flare‐progression strategy with pimecrolimus cream 1% in the management of paediatric atopic dermatitis
Author(s) -
Sigurgeirsson B,
Ho V,
Ferrándiz C,
Andriano K,
Grinienko A,
Jimenez P
Publication year - 2008
Publication title -
journal of the european academy of dermatology and venereology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.655
H-Index - 107
eISSN - 1468-3083
pISSN - 0926-9959
DOI - 10.1111/j.1468-3083.2008.02785.x
Subject(s) - pimecrolimus , medicine , atopic dermatitis , dermatology , randomization , randomized controlled trial , calcineurin , surgery , transplantation
Objective This study was performed to investigate the efficacy and safety of a prevention‐of‐flare‐progression strategy with pimecrolimus cream 1% in children and adolescents with atopic dermatitis (AD). Methods A 26‐week multi‐centre, randomized, double‐blind, vehicle‐controlled study was conducted in 521 patients aged 2–17 years, with a history of mild or moderate AD, who were clear/almost clear of disease before randomization to pimecrolimus cream 1% ( n = 256) or vehicle cream ( n = 265). Twice‐daily treatment with study medication was started at the first signs and/or symptoms of recurring AD. If, despite the application of study medication for at least 3 days, AD worsened (as confirmed by the investigator), treatment with a moderately potent topical corticosteroid (TCS) was allowed in both groups. The primary efficacy end point was the number of days on study without TCS use for a flare. Results The mean number of TCS‐free days was significantly higher ( P < 0.0001) in the pimecrolimus cream 1% group (160.2 days) than in the control group (137.7 days). On average, patients on pimecrolimus cream 1% experienced 50% fewer flares requiring TCSs (0.84) than patients on vehicle cream (1.68) ( P < 0.0001). Patients on pimecrolimus cream 1% also had fewer unscheduled visits (87) than patients on vehicle cream (246). Conclusions In children and adolescents with a history of mild or moderate AD but free/almost free of signs or symptoms of the disease, early treatment of subsequent AD exacerbations with pimecrolimus cream 1% prevented progression to flares requiring TCS, leading to fewer unscheduled visits and reducing corticosteroid exposure.