Significant Disease Burden Found in Children With Moderate to Severe AD

Uncontrolled disease burden was a major unmet need among children with moderate to severe atopic dermatitis (AD) who were unresponsive to topical therapies.

Children with moderate to severe atopic dermatitis (AD) who are unresponsive to topical therapies may be prone to significant disease burden, including worse nocturnal/daily itching and adverse quality of life. Findings were reported at the 2022 American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting and are published in The Journal of Allergy and Clinical Immunology.

In AD management, pediatric patients have been cited as a population with major unmet needs. Prior studies have shown significant associations with sleep and behavioral issues in affected children, as well as a greater risk of comorbidity, including asthma, allergic rhinitis, or seasonal allergies, despite the level of disease severity.

With moderate to severe AD already associated with a lack of therapeutic options, researchers sought to investigate the real-world disease burden of pediatric patients younger than 12 years who present with this disease severity

They leveraged data of the Observational Evaluation of Atopic Dermatitis in Pediatric Patients (PEDISTAD) clinical trial, an ongoing, 5-year, international, prospective, non-interventional study of patients aged younger than 12 years with investigator-assessed moderate to severe AD that is inadequately controlled with topical therapies or for whom such therapies are inadvisable.

Participants’ disease burden was evaluated by several baseline-reported measures:

  • Physician-assessed Eczema Area and Severity Index (EASI; 0-72) and AD-affected body surface area (BSA)
  • Patient/caregiver-reported Patient-Oriented Eczema Measure (POEM; 0-28)
  • Infant’s Dermatitis Quality of Life (IDQOL; < 4 years; 0-30) or Children’s Dermatology Life Quality Index (CDLQI; 4 to < 12 years; 0-30),
  • Worst scratching in the previous 24 hours (0 to < 6 years; 0-10) or worst itching during the previous night/current day (6 to < 12 years; 0-10)

A total of 732 patients with AD (mean [SD] age, 6.2 [3.2] years; median [interquartile range] age at AD onset, 0.7 [0.3–2.0] years; 52.2% male) were included in the analysis, in which 59.0% reported incidence of type 2 inflammatory comorbidities.

Mean [SD] baseline outcome measures demonstrated significant disease burden: EASI (14.4 [10.7]), percentage of AD-affected BSA (33.3 [21.0]), POEM score (15.6 [7.2]), IDQOL score (10.3 [6.1]), CDLQI score (10.8 [6.7]), worst scratching in 24 hours (5.9 [2.7]), worst itching-night (4.9 [2.9]), and worst itching-day (3.8 [2.7]).

Itching was the most frequent symptom by the proportion of patients reporting POEM items, followed by dry/rough skin, cracked skin, flaking skin, disturbed sleep, bleeding, and weeping/oozing. Results were noted to be similar across age groups (0 to < 2, 2 to < 6, 6 to < 12 years) for disease burden outcomes.

“Children with moderate to severe AD aged younger than 12 years in PEDISTAD had significant disease burden, reflecting a major unmet need for effective disease control,” concluded the study authors.


The patient burden of moderate-to-severe atopic dermatitis (AD) in children aged <12 years: Results from 732 patients in the PEDIatric STtudy in Atopic Dermatitis (PEDISTAD) observational study. J Allergy Clin Immunol. Published online February 1, 2022. doi:10.1016/j.jaci.2021.12.066

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