SAN FRANCISCO, CA -- March 24, 2003 -- Tacrolimus 0.1% ointment appears to be both safe and effective for the treatment of atopic dermatitis in children and adults when used for more than 3 years.

In an open-label study, adults and children at least 2 years of age with atopic dermatitis applied 0.1% tacrolimus ointment twice daily during episodes of atopic dermatitis. They continued applying the ointment for 1 week after clearing of the lesions.

Lead author Dr. A. Paller, from the Children's Memorial Hospital in Chicago, Illinois, United States, presented the findings in a poster here March 22^nd at the 61^st Annual Meeting of the American Academy of Dermatology.

Overall, 799 patients received at least one dose of 0.1% tacrolimus ointment and were eligible for efficacy and safety assessments. A total of 300 patients participated in the study for more than 3 years. Forty-nine% of patients were children aged 2 to 15 years. Patients were followed for a median duration of 33 months, up to a maximum of 49 months.

During the trial, 83.9% of patients were using tacrolimus ointment alone; the remaining patients used a topical corticosteroid at some point during their follow-up, usually for less than 30 days.

Patients began to experience improvement within a week of using tacrolimus. Specifically, 73% of patients experienced a decrease from baseline in their Eczema Area and Severity Index (EASI) score, and 52% experienced a decrease from baseline in the percent of their body surface area affected by atopic dermatitis.

As the study continued, patients experienced further improvements. Overall, 80% of patients experienced improvements in their EASI score, and 78% had reductions in the percent body surface area affected. There was no loss of effectiveness over time.

The drug was safe and there was no evidence for an increased risk of any adverse event, including infections, with up to 4 years of use. Common side effects included flu-like symptoms, pruritis, skin burning, allergy and skin infection, and most diminished on their own with time.


The study was sponsored by Fujisawa Healthcare, Inc., manufacturers of tacrolimus.

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