Efficacy and Safety of Tacrolimus Ointment Treatment for up to 4 Years in Patients With Atopic Dermatitis

Abstract

Purpose of the Study. This study was designed to evaluate the long-term safety and efficacy of 0.1% tacrolimus ointment in adult and pediatric patients with atopic dermatitis (AD). Study Population. A total of 408 adult and 391 pediatric patients with moderate-to-severe AD who had participated in a previous clinical trial of tacrolimus ointments. The pediatric patients were from 2 to 15 years of age (185 patients aged 2–6 years, and 206 patients aged 7–15 years), and 93.5% of the patients had severe AD. Methods. Tacrolimus ointment 0.1% was applied twice daily either intermittently or continuously to the affected areas. Efficacy and safety assessments included percent body surface area affected, Eczema Area and Severity Index score, individual signs of AD, and the incidence of adverse events. Patients were treated for a range of 1 to 1186 days (median: 982 days). A total of 37.5% of the patients in the study were treated for >3 years. Results. Improvements in efficacy parameters were observed within 1 week of treatment and continued for the duration of the study. Common adverse events included skin burning, pruritus, skin infection, skin erythema, flu-like symptoms, and headache. The incidence of adverse events, including cutaneous infections, did not increase with time on treatment. Conclusion. Tacrolimus ointment therapy is a rapidly effective and safe treatment for the management of AD in pediatric and adult patients for up to 4 years. Reviewer Comments. This study shows no long-term adverse effects of this topical calcineurin inhibitor in the treatment of AD. Most patients had >2½ years of treatment without increase in the number or incidence of infections. If these drugs were systemically immunosuppressive, the number of cutaneous or systemic infections would have been expected to increase.