Tacrolimus Ointment for the Treatment of Atopic Dermatitis: Report of First Clinical Experience in Taiwan

Atopic dermatitis (AD) is a pruritic recurring inflammatory skin disease. Recently, topical tacrolimus has been developed to treat AD. This report presents the first clinical experience with topical tacrolimus in Taiwan. This open-label, single-arm study was conducted at three centers from February to May 2002. The duration of each individual treatment was 4 weeks. Two groups were defined: pediatric and adult. Efficacy was evaluated on the basis of the physician's global evaluation at the end of treatment. Success was defined as at least 50% improvement. Other evaluations included the Eczema Area and Severity Index (EASI), the percentage of body surface area (BSA) involved, the patient's assessment of pruritus, and the patient's assessment of overall response. Safety profile was established by monitoring changes in hematology and biochemistry profiles and tacrolimus concentration in blood. All adverse events were recorded. Twenty-six pediatric patients and 42 adult patients were enrolled. Overall success rates were 80.8% and 82.1% in the pediatric and adult groups, respectively. The declines in EASI, percentage of BSA affected, and patient's assessment of pruritus were significant (p < 0.001); 88% and 100% of pediatric and adult patients, respectively, reported a favorable response to treatment. Changes in blood samples were unremarkable. Of pediatric and adult patients, 61.5% and 76.2%, respectively, reported adverse events. The most common adverse event reported was skin burning, which did not result in discontinuation of therapy. This report reveals that tacrolimus ointment is effective and safe for the treatment of AD in Taiwanese patients