Tacrolimus ointment is currently recommended as a second-line therapy for moderately severe to severe atopic dermatitis in patients older than 2 years. However, most studies of its efficacy compared it only to vehicle ointment. Very little information exists on its efficacy compared to corticosteroids.

Therefore, Peter D. Arkwright, MD, Senior Lecturer in Paediatric Immunology, University of Manchester, Manchester, United Kingdom, and colleagues conducted a head-to-head comparison between tacrolimus and corticosteroids for treatment of children with atopic dermatitis.

The study enrolled 41 male and 36 female paediatric patients with moderately severe to severe atopic dermatitis enrolled. Ages ranged from 6 months to 18 years; median age was 5 years.

Researchers evaluated the effectiveness of 0.03% tacrolimus ointment compared to the standard topical corticosteroid treatment. If the 0.03% tacrolimus preparation had no effect, the 0.1% strength was used. The stronger product is not approved for paediatric use in the United States or the U.K., but about 25% of children with moderately severe to severe atopic dermatitis respond to it, Dr. Arkwright said.

Of 74 children who completed the study, 81% experienced greater improvement with the ointment compared to topical corticosteroids, Dr. Arkwright said. Of those who responded to tacrolimus, about two-thirds responded to the 0.03% preparation, while the remainder required the 0.1% ointment.

"Tacrolimus seems to have a niche in the management of these patients, but it's not a panacea; about 20% of these children will not respond," Dr. Arkwright said.

Children receiving moderate or potent topical corticosteroids prior to entering the study had a significantly lower chance of responding to tacrolimus, which suggests that children whose eczema was inadequately controlled by the corticosteroids were less likely to respond to tacrolimus ointment in either strength, he added.

Six children complained of burning and redness for 3 to 5 days after application of tacrolimus, but all of those cases resolved within a week, and there were no other severe adverse effects.

Dr. Arkwright estimated that about 2% to 5% of children with eczema have the more severe forms that might benefit from tacrolimus.


[Presentation title: Blinded Side-to-Side Comparison of Topical Corticosteroid and Tacrolimus Treatment in Children With Moderate-Severe Eczema. Poster 1156]

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