The Safety Data of Dupilumab for the Treatment of Moderate‑to‑Severe Atopic Dermatitis in Infants, Children, Adolescents, and Adults.

ABSTRACT:

Background

Atopic dermatitis (AD) significantly affects quality of life in patients of all ages and requires long-term treatment. Dupilumab is approved for uncontrolled moderate-to-severe AD in patients aged ≥ 6 months and in other type 2 inflammatory diseases. Data from placebo-controlled, randomized clinical trials (RCTs) and long-term open-label extensions (OLEs) enable comprehensive assessment of dupilumab's safety profile for up to 5 years.

Objective

To integrate short- and long-term dupilumab safety data in patients with moderate-to-severe AD.

Methods

We describe safety from eight phase 3 trials with > 7000 patient-years of dupilumab use: five 16-week RCTs in children (6 months-11 years, with concomitant topical corticosteroids [TCS]) and adolescents and adults

SUBMITTER: Langley RG 

PROVIDER: S-EPMC12615541 | biostudies-literature | 2025 Nov

REPOSITORIES: biostudies-literature