Dupilumab reduces inflammatory biomarkers in pediatric patients with moderate-to-severe atopic dermatitis.

BACKGROUND

Patients with atopic dermatitis (AD) often have elevated type 2 inflammatory serum biomarkers.

OBJECTIVE

The aim was to report changes in thymus and activation-regulated chemokine (TARC)/CC chemokine ligand 17 (CCL17), total IgE, lactate dehydrogenase (LDH), and eosinophils in pediatric patients treated with dupilumab or placebo.

METHODS

Biomarker data were analyzed from 3 randomized, double-blind, placebo-controlled, phase 3 studies of patients with moderate-to-severe AD. Patients ages 6 months to 5 years were randomly assigned to weight-dependent dupilumab 200/300 mg every 4 weeks (q4w) or placebo; ages 6 to 11 years, to dupilumab 100/200 mg every 2 weeks (q2w), dupilumab 300 mg q4w, or placebo; ages 12 to 17 years, to dupilumab 200/300 mg q2w, dupilumab 300 mg q4w, or placebo. In the youngest 2 groups, topical corticosteroids were also applied. Median percent changes from baseline to week 16 were reported using last observation carried forward analysis, censoring after rescue treatment.

RESULTS

Pediatric patients who received dupilumab versus placebo achieved significantly greater median percent reductions at week 16 in TARC/CCL17 (-83.3% to -72.4% vs -14.9% to -1.8%), total IgE (-71.2% to -58.4% vs -21.0% to +28.1%), and LDH (-26.2% to -9.8% vs -1.5% to +1.5%). All comparisons were significantly different (P < .0001) between each dupilumab dosing group and respective placebo groups. In contrast, absolute changes in eosinophils were small in all groups.

CONCLUSIONS

Dupilumab treatment for pediatric patients with moderate-to-severe AD significantly reduced levels of TARC/CCL17, total IgE, and LDH to levels comparable with those of healthy controls, reflecting a reduction in systemic type 2 and general inflammation.