Sublingual immunotherapy in mite-sensitized children with atopic dermatitis: a randomized, double-blind, placebo-controlled study.

BACKGROUND Atopic dermatitis often has an allergic component, and immunotherapy may therefore prove beneficial. OBJECTIVE To assess the effect of sublingual immunotherapy (SLIT) in children with atopic dermatitis. METHODS Children age 5 to 16 years with atopic dermatitis (Scoring Atopic Dermatitis [SCORAD] > 7) and sensitization to dust mites alone, without food allergy or chronic asthma, were enrolled in a randomized, double-blind, placebo-controlled study and stratified according to disease severity. SLIT or placebo was given for 18 months in addition to standard therapy. SCORAD, visual analog scale, and rescue medication consumption were recorded at 3-month intervals. RESULTS Fifty-six children were enrolled, and 28 were allocated to SLIT. Forty-eight completed the study, with 2 dropouts in the active and 6 in the placebo group. The difference from baseline in the SCORAD was significant (P = .025) between the 2 groups starting from month 9. Similarly, there was a significant reduction in the use of medications only in the active group. A trend toward significance was seen for the visual analog score only in the active group versus baseline (P = .07). A significant difference in the considered parameters was found only in patients with a mild-moderate disease, whereas severe patients had only a marginal benefit. SLIT had to be discontinued in 2 patients because of exacerbation of dermatitis. CONCLUSION Sublingual immunotherapy to dust mite improves mild-moderate atopic dermatitis. CLINICAL IMPLICATIONS Sublingual immunotherapy may represent an additional therapeutic tool for the treatment of extrinsic atopic dermatitis in properly selected children.