Safety and efficacy of 1 year of tacrolimus ointment monotherapy in adultswith atopic dermatitis

Objective: To investigate the safety and efficacy of using 0.1% tacrolimus ointment for long-term treatment of atopic dermatitis. Design: Open-label, noncomparative study with 6 to 12 months of follow-up. Settings: Outpatient departments in 30 study centers in 11 European countri es. Patients: We enrolled 316 patients aged 18 years and older with moderate to severe atopic dermatitis, 200 for 6 months and 116 for 12 months; 77.5% of patients completed the study. Intervention: Twice-daily application of 0.1% tacrolimus ointment. on all a ffected skin. Visits were scheduled on day 1; after 1, 2, and 4 weeks of tr eatment; and monthly thereafter. Main Outcome Measures: Safety assessments included monitoring of adverse ev ents, clinical laboratory values, and tacrolimus blood concentrations. Effi cacy end points included a combined score (modified Eczema Area and Severit y Index) and an investigator's global assessment. Results: Local irritation, adverse events such as burning sensation (47% of patients), pruritus (24% of patients), and erythema (12% of patients) were common but tended to occur only when initiating treatment. laboratory valu es showed no marked changes over time. Systemic absorption was minimal, wit h the maximum tacrolimus blood concentration being less than 1 ng/mL in 76% of patients. All efficacy end points showed improvement. The mean (SD) mod ified Eczema Area and Severity Index score was 23.7 (12.6) at day 1, 13.5 ( 11.3) at week 1, 6.1 (9.2) at month 6, and 6.1 (8.1) at month 12. Marked or excellent improvement or clearance of disease was reported in 54%, 81%, an d 86% of patients at week 1, month 6, and month 12, respectively. Conclusion: Up to 1 year of tacrolimus ointment use was safe and effective in patients with atopic dermatitis.