Dupilumab Treatment Reduces Total IgE Levels in Patients 6 Months and Older with Moderate-to-Severe Atopic Dermatitis

Journal of Allergy and Clinical Immunology(2023)

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摘要
Atopic dermatitis (AD) is a type 2 inflammatory disease characterized by elevations in several biomarkers including serum IgE – a key downstream mediator in the type 2 adaptive immune response. To report the effect of dupilumab treatment on total serum levels of IgE in patients with moderate-to-severe AD. Patients with moderate-to-severe AD were enrolled for 16 weeks in any of six randomized, placebo-controlled, phase 3 studies: in LIBERTY AD PRESCHOOL (NCT03346434 part B) patients aged 6 months to 5 years were treated with dupilumab 200/300 mg every 4 weeks (q4w) + topical corticosteroids (TCS; n = 83), or placebo + TCS (n = 79); in LIBERTY AD PEDS (NCT03345914) patients aged 6–11 years were treated with dupilumab + TCS (100/200 mg q2w [n = 122], 300 mg q4w [n = 122]), or placebo + TCS (n = 123); in LIBERTY AD ADOL (NCT03054428) patients aged 12–17 years were treated with dupilumab (200/300 mg q2w [n = 82], 300 mg q4w [n = 83]), or placebo (n = 85); and in LIBERTY AD CHRONOS/SOLO1/SOLO2 (NCT02260986/NCT02277743/NCT02277769, pooled) patients aged ≥ 18 years were treated with dupilumab (300 mg q2w [n = 563], 300 mg qw [n = 781]), or placebo (n = 775). TCS were allowed in CHRONOS only. At week 16, dupilumab treatment significantly (P < 0.0001) reduced median total serum IgE levels (kU/L [IQR]) compared with placebo in patients aged 6 months to 5 years (843 [207–3,300] vs. 3,625 [540.5–8,585]), 6–11 years (1,519 [532–3,808] vs. 3,862 [1,166–9,999]), 12–17 years (1,391 [436–2,842] vs. 4,569 [800.5–10,000]), and ≥ 18 years (1,340 [229–4,360] vs. 3,722 [555–10,000]). Dupilumab treatment reduced total serum IgE levels in patients aged 6 months and older with moderate-to-severe AD. Overall safety was consistent with the known dupilumab safety profile.
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关键词
cross-Age, moderate-to-severe, biomarkers, type 2 inflammation, IgE
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