Tacrolimus ointment for the treatment of atopic dermatitis in adult patients: Part I, Efficacy

A total of 632 adults with atopic dermatitis applied tacrolimus ointment (0 .03% or 0.1%) or vehicle twice daily for up to 12 weeks in two randomized, double-blind studies. This report focuses on the efficacy of tacrolimus oin tment in these studies. The mean percent body surface area (%BSA) affected at baseline was 45%, and 56% of patients had severe atopic dermatitis. Eval uations included a physician's global evaluation of clinical response, %BSA affected, individual signs of atopic dermatitis, the Eczema Area and Sever ity Index (EASI) score, and the patient's assessment of pruritus. A 90% or greater improvement from baseline in disease status was observed for 6.6%, 27.5%, and 36.8% of patients in the vehicle, 0.03% tacrolimus ointment, and 0.1% tacrolimus ointment groups, respectively (P < .001), and 50% or bette r improvement was observed for 19.8%, 61.6%, and 72.7% of patients, respect ively. Tacrolimus ointment-treated patients showed significantly greater im provement than vehicle-treated patients for all efficacy parameters evaluat ed, including the %BSA affected, the total score and individual scores for signs of atopic dermatitis, the patient's assessment of pruritus, and EASI score. The 0.1% concentration was more effective than the 0.03% concentrati on, particularly in patients with severe disease and/or extensive BSA invol vement at baseline and in African Americans. Tacrolimus ointment is an effe ctive therapy for the treatment of adult patients with atopic dermatitis on all skin regions including the head and neck.