Long‐term safety and tolerability of pimecrolimus cream 1% and topical corticosteroids in adults with moderate to severe atopic dermatitis

Abstract

OBJECTIVE: This randomized, double‐blind, multi‐centre study compared the long‐term safety and tolerability of pimecrolimus cream 1% and topical corticosteroids (TCS) in 658 adults with moderate–severe atopic dermatitis (AD).METHODS: Patients applied either pimecrolimus or TCS (i.e. 0.1% triamcinolone acetonide cream and/or 1% hydrocortisone acetate cream) twice daily to all affected areas until complete clearance or for up to 1 year. The study was approved by the institutional review board or ethics committee at each centre.RESULTS: A majority of patients treated with either pimecrolimus or TCS used the drug on a continuous basis over 1 year. In patients who had >30% of the body surface involved by AD, the incidence rate of all skin infections was significantly lower in the pimecrolimus group than in the TCS group (95% CI of the treatment difference: −25.3% to −3.4%). The most frequent application site reaction was burning (25.9% of patients on pimecrolimus and 10.9% on TCS), which was transient and mild–moderate in most cases. Three TCS‐treated patients reported skin striae. There were no treatment‐related serious or clinically significant systemic adverse events. Efficacy was better in patients on continuous TCS therapy, although patients completing the study were similarly well‐controlled in both groups. About 42% of the pimecrolimus‐treated patients were maintained for 1 year without TCS.CONCLUSION: Pimecrolimus demonstrated a favourable safety profile when used to treat adult patients with moderate–severe AD for up to 1 year. A significant proportion of patients could be maintained without TCS for a year.