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Dupilumab treatment in children aged 6–11 years with severe atopic dermatitis is associated with reductions in serum immunoglobulin E and thymus and activation-regulated chemokine levels

2023; Elsevier BV; Volume: 63; Issue: 3 Linguagem: Inglês

10.1016/j.reval.2023.103436

1877-0320

Michael J. Cork, A. Wollenberg, E.C. Siegfried, A.B. Rossi, Z. Chen, N.A. Levit, A. Rodriguez Marco,

Allergic Rhinitis and Sensitization

Atopic dermatitis (AD) is a chronic systemic inflammatory condition predominantly driven by dysregulated type 2 immunity. AD and other type 2 inflammatory comorbidities associated with elevated serum IgE and Thymus and activation-regulated chemokine (TARC) are particularly common in children aged 6–11 years. Dupilumab studies have previously demonstrated the suppression of type 2 biomarkers including IgE across multiple diseases in adults. To present the effect of dupilumab on serum IgE and TARC levels in children aged 6–11 years with severe AD. In the LIBERTY AD PEDS study (NCT03345914), children were randomized 1:1:1 to dupilumab 300 mg every 4 weeks (q4w), 100 mg/200 mg every 2 weeks, or placebo, with concomitant medium-potency topical corticosteroids (TCS). Mean absolute serum IgE and TARC levels (standard deviation [SD]) were evaluated at Baseline/week 16 and Baseline/week 4/week 16, respectively. Only data for the EMA-approved 300 mg q4w dupilumab dosing regimens (n = 122) and placebo treated (n = 123) groups are shown. IgE concentrations (SD) were similar across both groups and markedly elevated at baseline (placebo: 9561.7 kU/L [12,955.4]; dupilumab: 9,755.5 kU/L [13,635.1]). In the placebo group, IgE concentrations remained elevated at week 16 (8,258.7 kU/L [10,541.5]). Dupilumab treatment substantially reduced IgE concentrations compared to baseline (3,458.0 kU/L [5,113.9]) at week 16. TARC concentrations (SD) were similar across both groups at baseline (placebo: 4,364.1 pg/mL [7,656.2]; dupilumab: 3,239.1 pg/mL [6,276.1]). Dupilumab treated patients demonstrated a large and sustained reduction in TARC concentration compared to placebo at week 4 (placebo: 2,743.6 pg/mL [3,393.1]; dupilumab: 668.9 pg/mL [613.0]) and week 16 (placebo: 2,591.6 pg/mL [3,637.7]; dupilumab: 508.4 pg/mL [566.7]). Dupilumab was generally well tolerated with a favourable safety profile. Dupilumab treatment reduces serum TARC and IgE levels in paediatric patients aged 6–11 years old with severe AD over 16 weeks, reflecting robust abrogation of systemic type 2 inflammation.