Topical tacrolimus and corticosteroids in childhood moderate-to-severe atopic dermatitis with impact on airways: A long-term randomized open-label study.

BACKGROUND: Childhood atopic dermatitis (AD) is often followed by other atopic comorbidities like asthma.

OBJECTIVE: To compare effectiveness of topical tacrolimus (TAC) and topical corticosteroids (TCSs) and their impact on airway inflammation and bronchial hyperresponsiveness in pediatric AD.

METHODS: A three-year randomized open-label comparative follow-up study of 152 one- to three-year-old children with moderate-to-severe AD. Frequent study visits including clinical examinations, laboratory investigations (total IgE, specific IgEs, blood eosinophils), skin prick and respiratory function tests to assess airway inflammation and bronchial hyperresponsiveness (exhaled nitric oxide, airway responsiveness to exercise and methacholine), were performed.

RESULTS: Changes in eczema parameters at 36 months were similar in the TCS and TAC groups for mean body surface area difference 1.4 (95% CI -1.48 to 4.19; P=.12), mean Eczema Area and Severity Index difference 0.2 (95% CI -1.38 to 1.82; P=.2), mean Investigator Global Assessment difference, 0.3 (95% CI -0.12 to 0.67; P=.12), and mean transepidermal water loss difference at eczema site, 0.3 (95% CI -4.93 to 4.30; P=.96), and at control site, 9.0 (95% CI 0.96 to 3.60, P=.19). Control TEWL increased more towards end in TCS vs TAC group (mean change difference 4.2; 95% CI -8.14 to -0.29; P=.0.04). No significant impact on development of airway inflammation or bronchial hyperresponsiveness occurred between early effective eczema-treatment responders vs others.

CONCLUSION: Children with moderate-to-severe AD benefit from long-term treatment with TCS or TAC. There were no significant differences in treatment efficacy. No differences on impact on airways occurred between early effective treatment responders vs others. (EudraCT2012-002412-95).