A 5-year randomized study to investigate the safety of pimecrolimus cream 1% in the treatment of mild-to-moderate atopic dermatitis in infants: Clinical safety

Atopic dermatitis (AD) is an inflammatory skin disease that is characterized by erythematous, papular, or vesicular lesions in the acute phase of the disease, and by lichenified areas in the chronic phase. AD may persist for very prolonged periods, or it may be of a relapsing, remitting nature. AD is predominantly a disease of early infancy and childhood. The conventional treatment for AD mainly involves emollients, and reactive use of topical corticosteroids (TCS) for disease exacerbations during the acute phase. As part of the original US registration program for pimecrolimus cream 1%, two phase III studies that established clinical efficacy were conducted in infants 3 to 23 months of age. The present study was a 5-year randomized open-label study to investigate the safety (compared with topical corticosteroids [TCS]) of pimecrolimus cream 1% in the treatment of AD in infants 3 to 11 months of age, and to assess the effects on the development of the immune system in infants with AD. This presentation will focus on findings as they relate to clinical safety.∗ Patients were randomized in a 1:1 ratio to receive treatment, as needed, for up to 5 years with a pimecrolimus cream 1%ebased regimen (pimecrolimus cream 1% at the first signs or symptoms of AD; TCS for severe exacerbations) or a TCS-based regimen. The study started in April 2004 and the final patient visit is scheduled to take place in November 2010. A total of 2439 patients were randomized, and more than 8000 patient-years of data have already been recorded. Based on the latest (2009) interim analysis, patients in the safety population (ie, patients who were randomized and received at least one application of study medication) had, at baseline, a mean (±SD) age of 7.2 (±2.7) months and all but 3 patients had an overall Investigator's Global Assessment of “mild” (46.6%) or “moderate” (53.2%) disease. Mean (±SD) baseline total body surface area affected was 21.2% (±16.8%), and 38.5% of patients were female. An independent semiblinded DSMB had no major findings. Clinical safety, in terms of adverse events data, will be presented. The results of this clinical study in an infant population, unprecedented in a dermatologic indication in terms of size and duration, are expected to provide key new insights regarding the safety of pimecrolimus cream 1% in the treatment of AD in infants. ∗Study findings relating to immunologic parameters can be found in abstract P1310 by Poulin et al.