Review of pimecrolimus cream 1% for the treatment of mild to moderate atopic dermatitis.

BACKGROUND: Atopic dermatitis (AD) is a pruritic and inflammatory skin disease affecting at least 28 million people in the United States. During an AD flare, the skin becomes inflamed and intensely pruritic. A "major flare" is characterized by persistent or uncontrollable pruritus, intense erythema, extensive excoriation, and potential oozing and crusting. The overall goal of AD treatment is to minimize the frequency and severity of disease flares. Long-term management involves multiple treatment strategies, including identifying and eliminating triggers, routine moisturization, antipruritic therapy, and use of topical anti-inflammatory agents (topical corticosteroids and topical calcineurin inhibitors). Pimecrolimus cream 1% is a topical calcineurin inhibitor developed specifically for patients with AD.

OBJECTIVE: The aim of this review was to assess the current literature (clinical trials and postapproval studies) on the efficacy and safety of pimecrolimus cream 1% in the treatment of AD.

METHODS: A literature search was performed using the National Library of Medicine (MEDLINE), EMBASE, International Pharmaceutical Abstracts, Current Contents, and SciSearch databases (1980-2006) with the search term pimecrolimus. Selected studies comprised randomized, vehicle-controlled trials of topical pimecrolimus cream 1%, focused on efficacy and safety, and complied with the pimecrolimus cream 1% indication (study participants were aged >or=2 years with mild to moderate AD).

RESULTS: When used in appropriately identified pediatric and adult patients with mild to moderate AD, pimecrolimus cream 1% improved the signs and symptoms of AD and delayed time to a major flare. The most commonly seen adverse events in clinical trials were application-site reactions (10.4%-14.5%) and nasopharyngitis (10.1%-28.9%), headache (13.9%-23.0%), cough (11.6%-19.3%), pyrexia (7.5%-15.4%), influenza (3.0%-14.6%), and bronchitis (0.4%-13.2%), which overall were not significantly different from patients treated with vehicle cream. Pimecrolimus cream 1% was not associated with skin atrophy (supporting its use on sensitive areas of the skin such as the face, neck, and skinfolds). In addition, a review of the literature identified no reports of cumulative irritation or photosensitivity potential, no substantial increases in the incidence of common bacterial and viral skin infections compared with vehicle cream (placebo), and no effects on the systemic immune system, including delayed-type hypersensitivity.

CONCLUSION: Pimecrolimus cream 1% is a valuable treatment option for mild to moderate AD in adults and children aged >or=2 years.