Children and adolescents with atopic dermatitis demonstrate significant improvement in SCORing Atopic Dermatitis (SCORAD) outcomes following dupilumab ± topical corticosteroids administration.
Atopic dermatitis (AD) is amongst the most prevalent inflammatory dermatoses in children. Moderate-to-severe AD is characterized by increased health burden and poor quality of life (QoL). Affected individuals are more likely to be diagnosed with asthma, allergic rhinitis, depression, attention deficit disorders, and other conditions. Dupilumab is a human monoclonal antibody known for significantly improving the signs, symptoms, and QoL associated with AD.
This post hoc analysis, published in Acta Dermato-Venereologica, includes data from one open-label extension (OLE) study and two RCTs, comprising a total of 471 pediatric patients. The study analyzed the SCORing Atopic Dermatitis (SCORAD) outcomes in AD patients who received dupilumab ± topical corticosteroids (TCS) for a duration of 16 weeks. SCORAD is divided into 3 components. Part A determines the extent of the disease, part B determines the intensity of disease signs, and part C assesses the disease symptoms. Parts A and B were assessed by the investigator, and the caregiver/patient assessed the symptoms for part C. A total of 304 children were randomized to dupilumab with TCS or placebo, whereas 167 adolescents were randomized to monotherapy with dupilumab or placebo.
The analysis demonstrated that pediatric patients who received dupilumab ± TCS had significantly decreased SCORAD outcomes, individual SCORAD components (A, B, and C), and objective SCORAD (oSCORAD) as compared to placebo in the randomized control trials from weeks 3 to 16. SCORAD is a measurement scale used by dermatologists to investigate the severity of disease and make treatment decisions. Objective, or o-SCORAD, is obtained via objective investigator assessment of the extent and intensity of the disease. Subjective symptoms (itch and sleeplessness) are assessed on a visual analogue scale by the patients or a relative, with 0 representing no itch (or no sleepiness) and 10 being the worst itch possible (or sleeplessness).
The study results either continued to improve or remained persistent over a year of administering open-label treatment comprising dupilumab ± TCS. Approximately 91.3–91.8% of the patients achieved SCORAD-50, indicating a 50% decrease in SCORAD by week 52. These patients received continued treatment with dupilumab across groups that included children ages 6 to less than 12 years, and adolescents ages 12 to less than 18 years.
At week 52, >86% of the patients had achieved the absence of pruritus and sleep loss or were experiencing mild pruritus and sleep loss symptoms. Among the SCORAD signs, there was a 75–82% and 88–90% reduction in excoriation and oozing in the patients by week 52. The treatment-emergent adverse events (TEAE) rates were lower in children who received dupilumab + TCS as compared to the placebo + TCS control arm.
In summary, the analysis of the SCORAD outcomes revealed that dupilumab ± TCS treatment is associated with significant and rapid improvements in all SCORAD components with the sustainability of the results over a year.
Wollenberg, A., Marcoux, D., Silverberg, J. I., Aoki, V., Baselga, E., Zhang, H., Levit, N. A., Taieb, A., & Rossi, A. B. (2022). Dupilumab Provides Rapid and Sustained Improvement in SCORing Atopic Dermatitis Outcomes in Paediatric Patients with Atopic Dermatitis. Acta Derm Venereol, 102, adv00726. https://doi.org/10.2340/actadv.v102.854