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Pimecrolimus cream 1% in the long-term management of adult atopic dermatitis: prevention of flare progression. A randomized controlled trial


  • Conflicts of interest
    This study was supported by Novartis Pharma AG. R.K. and staff members received honoraria for speaking and reimbursements for attending meetings in the context of clinical trials from Novartis. H.H. attended a symposium organized by Novartis, received payments to give lectures to general practitioners, and participated in a study on onychomycosis sponsored by Novartis. K.A., A.G. and P.J. are employees of Novartis and hold stock options in Novartis.

Harald Gollnick.


Background  Previous studies suggested that early intervention with pimecrolimus cream 1% at the first signs and/or symptoms of a relapse of atopic dermatitis (AD) following remission may prevent the occurrence of more severe flares and therefore reduce corticosteroid exposure in the long term. However, this possibility was not rigorously evaluated.

Objectives  To evaluate the effectiveness of pimecrolimus cream 1% for the prevention of flare progression in adults with AD.

Methods  A 26-week randomized controlled study was conducted in 543 patients aged ≥ 18 years, with a history of mild or moderate AD, who were clear/almost clear of disease before randomization to pimecrolimus cream 1% (= 277) or matching vehicle cream (= 266). Twice-daily treatment with study medication was started at the onset of the first signs and/or symptoms of a relapse. If disease worsened, despite the application of study medication for at least 3 days, treatment with a moderately potent topical corticosteroid (TCS) was allowed in both groups. The primary efficacy endpoint was the number of days without TCS use for disease worsening.

Results  The mean number of TCS-free days was significantly higher (< 0·001) in the pimecrolimus cream 1% group (152 days) than in the vehicle cream group (138·7 days). In comparison with vehicle cream, pimecrolimus cream 1% reduced the mean number of flares requiring TCS use from 1·39 to 0·97 (= 0·0014). Patients on pimecrolimus cream 1% made 30% fewer unscheduled visits (156) than patients on vehicle cream (223).

Conclusions  In adults with a history of mild or moderate AD but free of active skin lesions, intervention with pimecrolimus cream 1% at the first signs and/or symptoms of a subsequent recurrence reduces the number of flares requiring TCS use and decreases the number of disease-related office visits.

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