Efficacy and safety of topically applied tacrolimus ointment in patients with moderate to severe atopic dermatitis

Background: Tacrolimus is a T-cell-selective cytokine inhibitor. The topical formulation was specifically developed for treating inflammatory skin diseases, including atopic dermatitis (AD). The purpose of this study was to evaluate the efficacy and safety of topically applied tacrolimus ointment (Protopic®) in treating Taiwanese patients with moderate to severe AD. Methods: This was an open-labeled, non-comparative, single-center study. Enrolled patients applied Protopic® twice daily for up to 4 weeks. Efficacy was evaluated on the basis of the physician's global evaluation of clinical response (PG). Other evaluations included the Eczema Area and Severity Index and the percentage of body surface area; the total score for clinical signs was used for evaluating the efficacy. A safety assessment was based on adverse events reported by patients or observed by the physician. Blood was sampled for the evaluation of tacrolimus levels. Results: In total, 30 patients (16 pediatric and 14 adult patients) with moderate to severe AD were enrolled in this study. At the end of treatment, the PG was 92.3% for the pediatric group and 100% for the adult group. Other efficacy evaluations also showed significant improvement. Two patients had detectable blood tacrolimus concentrations. Skin itching and burning on the application site was a common but temporary side effect. No significant adverse events related to Protopic® were observed. Conclusion: The results of the study suggest that Protopic® ointment may be a safe and effective therapy for treating patients at least 2 years of age with moderate to severe AD.