Long-term efficacy and tolerability of tacrolimus 0.03% ointment in infants:* A two-year open-label study

Background Tacrolimus ointment is effective for treatment of moderate to severe atopic dermatitis (AD) in children aged ≥2years (Br J Dermatol, 2004; 150: 554). Here, efficacy and tolerability of tacrolimus 0.03% ointment were evaluated in 50 infants aged <2years at start of treatment. Methods Infants with AD previously enrolled in a tacrolimus ointment pharmacokinetics trial were eligible for a 24-month open-label phase II study. Tacrolimus 0.03% ointment was applied to affected areas until clearance. In cases of exacerbation or clinical worsening, patients restarted treatment. Results Mean±SD Eczema Area and Severity Index (EASI) score improved, from 11.2±10.5 baseline to 2.6±4.1 at endpoint (24months); mean affected body surface area decreased from 25.2±21.1% to 5.1±9.0%, with improvement on all items of the Physicians' Assessment of Individual Signs. The Physicians' Global Evaluation of Clinical Response showed a result of "cleared"/"excellent" for 63.3% of patients; 85.7% of parents/guardians assessed symptoms as "much better." Treatment was well tolerated, with common, nonserious respiratory infections and gastroenteritis the most frequently reported adverse events. The most common application-site events were infections and pruritus. Over 98% of blood samples showed tacrolimus concentrations <1.0ng/ml; >40% showed concentrations below the lower limit of quantification (0.0250ng/ml). Conclusions Over a period of two years, tacrolimus 0.03% ointment was associated with substantial clinical improvement of AD in infants aged <2years. Treatment tolerability was similar to that seen in older children.