Despite the level of disease severity of atopic dermatitis, children with the condition usually have at least 1 other inflammatory or atopic comorbidity, according to new study results.
A worldwide survey of children and adolescents (or their caregivers) with atopic dermatitis (AD) found that the majority have at least 1 comorbidity, including asthma, allergic rhinitis, or seasonal allergies, despite the level of disease severity.
The study, presented recently at the American Academy of Allergy, Asthma & Immunology (AAAAI) 2021 Annual Meeting, stratified children aged 6 months to 18 years by severity of disease in more than a dozen countries in 5 regions.
Depending on the age of the patient, the online survey was answered by the guardian only or by both children and guardians. AD severity was self-reported (except for children under 12 years) using the patient global assessment (PtGA) of disease severity (clear/mild, moderate, or severe), as well as the Patient-Oriented Eczema Measure (POEM).
Among the 7465 pediatric patients with diagnosed AD, 92.5% reported at least 1 atopic comorbidity, which tended to rise slightly with increasing age.
According to their answers on the PtGA about their disease over the prior week:
Patients of every disease level reported at least 1 comorbidity, including 90.9% with clear or mild disease, 94.5% with moderate disease, and 97.5% of those with severe disease.
The study was sponsored by Sanofi and Regeneron Pharmaceuticals, and this week the FDA accepted for review their supplemental Biologics License Application (sBLA) for dupilumab (Dupixent) as an add-on treatment for children aged 6 to 11 years with uncontrolled moderate-to-severe asthma.
Dupilumab is currently approved as an add-on treatment for patients with uncontrolled moderate-to-severe asthma aged 12 and older with elevated eosinophils or oral corticosteroid dependent asthma. The FDA is expected to make a decision by October 21, 2021, and the companies plan to file for approval in the European Union in the first quarter of 2021.
The filing is supported by phase 3 data about dupilumab from the LIBERTY asthma trial, which found that severe asthma attacks were cut by 65% over 1 year compared with placebo. More than 90% of children in the trial had at least one concurrent type 2 inflammatory condition including atopic dermatitis and eosinophilic esophagitis.
The study also found improved lung function at 12 weeks compared with baseline by 10.15 and 10.53 percentage points for dupilumab vs 4.83 and 5.32 percentage points for placebo (least squares mean difference, dupilumab vs placebo, 5.3 and 5.2 percentage points, P = .0036 and P = .0009), respectively, as measured by forced expiratory volume in 1 second.
Dupilumab, a biologic, inhibits the signaling of the interleukin-4 and interleukin-13 proteins.
Silverberg JI, Simpson EL, Weidinger S, et al. Children with atopic dermatitis (AD) have a high burden of atopic comorbidities: Results from a large worldwide survey. Presented at: 2021 Virtual Annual Meeting of the American Academy of Allergy, Asthma and Immunology (AAAAI); February 26-March 1, 2021.