Dupilumab treatment results in rapid, sustained and clinically meaningful improvement in itch in patients aged 6 months to 5 years with moderate-to-severe atopic dermatitis - 08/04/23
Résumé |
Introduction (contexte de la recherche) |
Atopic dermatitis (AD) is characterized by intense pruritus. Dupilumab treatment has demonstrated rapid onset of itch reduction in adults, adolescents, and school-age children in previous phase 3 studies.
Objectif |
To report the effect of dupilumab on itch in children aged 6 months to 5 years with moderate-to-severe AD.
Méthodes |
LIBERTY AD PRESCHOOL (NCT03346434 part B) was a 16-week, randomized, double-blind, placebo-controlled phase 3 study, during which children aged 6 months to 5 years were randomized 1:1 to dupilumab 200/300mg+topical corticosteroids (TCS) every 4 weeks (q4w; n=83), or placebo+TCS (n=79). Caregiver-reported Worst Scratch/Itch NRS scores (WSI-NRS; 0–10) were assessed from baseline to week 16.
Résultats |
From day 9, treatment with dupilumab 200/300mg q4w+TCS significantly improved itch compared to placebo+TCS, as measured by LS mean percent change from baseline in Daily WSI–NRS (−16.8% vs. +8.0%; [P=0.005]). At week 16, patients treated with dupilumab showed a significant reduction in LS mean percentage change from baseline in Weekly PP-NRS compared to placebo (−49.4% vs. −2.2%; [P<0.0001]). At week 2, 10.8% of patients treated with dupilumab showed ≥ 4-point improvement in average Weekly WSI–NRS, compared to 2.5% of the placebo group (P=0.04). The proportion of dupilumab-treated patients with ≥ 4-point improvement increased to 49.4% at week 16, compared to 12.7% in the placebo group (P<0.0001). Overall safety was consistent with the known dupilumab safety profile.
Conclusions |
Dupilumab treatment leads to rapid and sustained improvement in itch in children with moderate-to-severe AD aged 6 months to 5 years, with a significant effect seen as early as day 9.
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Vol 63 - N° 3
Article 103430- avril 2023 Retour au numéroBienvenue sur EM-consulte, la référence des professionnels de santé.
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