The safety and efficacy of tacrolimus ointment in pediatric patients with atopic dermatitis.

Atopic dermatitis (AD) is the most common skin disease in children, and its prevalence is increasing. It is a chronic disorder, characterized by intermittent flares and phases of remission. Treatment regimens often require multiple therapies. These can vary between patients, and in an individual patient, depending on the state of disease. The traditional treatment for AD flares is topical corticosteroids, which are fast acting and effective for relief of symptoms, but may cause adverse effects, including those resulting from systemic absorption, particularly in children. Topical calcineurin inhibitors (TCIs) are alternative treatments for AD. Tacrolimus ointment, a TCI, is approved for patients aged 2 years and older. Multiple studies have shown that tacrolimus is effective for short-term relief of symptoms in pediatric patients with AD. Long-term trials have demonstrated that the effectiveness of tacrolimus is maintained for up to 4 years in children. Additional studies have revealed that long-term intermittent use of tacrolimus as part of maintenance therapy can prevent AD flares. Tacrolimus has a low potential for systemic accumulation, and analysis of long-term studies indicates that it has a good safety profile. Treatment with tacrolimus, alone or in combination with topical corticosteroids for acute flares, may be a useful option for long-term management of AD in pediatric patients.