Reitamo S, Van Leent EJM, Ho V, et al. J Allergy Clin Immunol. 2002;109:539–546
Purpose of the Study.
To compare 0.03% and 0.1% tacrolimus ointment with 1% hydrocortisone acetate ointment in children 2 to 15 years of age with moderate-to-severe atopic dermatitis (AD).
Children ages 2 to 15 years with a diagnosis of AD were recruited from 27 centers in 6 European countries and Canada. Patients were required to have a severity grading of moderate to severe (using established criteria) and at least 5%, but not >60%, total body surface area (BSA) involvement.
This was a phase III, multicenter, randomized, double-blind, parallel-group trial. Patients were randomized (1:1:1) to receive 0.03% or 0.1% tacrolimus or 1% hydrocortisone acetate. Treatment included application of a thin layer of ointment twice daily to active skin lesions until clearing of lesions for 7 days. Other therapies were prohibited with the exception of inhaled or intranasal corticosteroids (maximum dose: 1 mg/day) and nonmedicated emollients or bath oils. Assessments were at baseline, days 3 and 7 and weeks 2 and 3 of treatment and 2 weeks after completing treatment (week 5). Assessments included investigator rating of skin disease and BSA involvement and patient symptoms assessment symptoms. These were used to calculate the modified eczema area and severity index (mEASI). A graded physician’s global evaluation regarding clinical response was also included. Adverse events and laboratory assessments were obtained.
A total of 560 patients were enrolled. Study discontinuations were as follows: 21 of 189 in 0.03% tacrolimus group, 13 of 186 in 0.1% tacrolimus group, and 20 of 185 in hydrocortisone group. The mEASI, mean area under the curve (mAUC) as percentage of baseline showed the 0.03% tacrolimus (44.8%) and 0.1% tacrolimus (39.8%) to be more effective than 1% hydrocortisone (64%), and 0.1% tacrolimus to be the most effective treatment. Transient skin-burning was reported more often in the tacrolimus groups. Laboratory parameters showed no treatment differences and no significant changes between groups.
Tacrolimus 0.03% and 0.1% ointments were more effective and showed equivalent safety when compared with 1% hydrocortisone in the treatment of children with moderate-to-severe AD.
This study demonstrates the usefulness and safety of tacrolimus ointment for children with moderate-to-severe AD. This new class of nonsteroid, immunomodulatory medications provides important therapeutic alternatives to long-term corticosteroid therapies for young children.