Topical use of pimecrolimus in atopic dermatitis: update on the safety and efficacy.

Pimecrolimus has been approved for more than five years for the treatment of atopic dermatitis in Germany. An important difference in the safety profile of this drug compared with topical corticosteroids is the lack of potential side effects which are often observed upon prolonged use of topical corticosteroids (skin atrophy, steroid-induced rosacea or perioral dermatitis). Even after prolonged use in sensitive skin areas, no tolerance to this drug is induced, in contrast to that seen with topical corticosteroids. The most common side effect of pimecrolimus is burning. Placebo-controlled studies suggest that pimecrolimus is associated with a slightly increased incidence of herpes simplex infections. Compared with topical corticosteroids, pimecrolimus does not increase the overall incidence of skin infections (including recurrent herpes simplex infections). So far, clinical studies with pimecrolimus have not shown any evidence of an increased risk of malignancy. The analysis of spontaneously reported adverse events has also not shown any evidence of malignancy caused by pimecrolimus. This corresponds with the results of a case-control study from a large U.S. database. According to the German guidelines on atopic dermatitis, topical calcineurin inhibitors are indicated when topical corticosteroids are not indicated or when an anticipated lengthy treatment course would lead to inevitable side effects. On sensitive areas such as face, intertriginous regions and scalp, they are preferred as first-line choice over topical corticosteroids