Study on Dupilumab and Atopic Dermatitis

A new study published in the Journal of American Academy of Dermatology found that Dupilumab improved atopic dermatitis (AD) symptoms as well as quality of life (QoL) in pediatric patients and caregivers/families.

The effects of moderate-to-severe atopic dermatitis on kids and caregivers are significant. Assessing several symptoms (such as pruritus and sleep disruption) is challenging for professionals. In addition to clinician-reported outcomes, patient-reported outcomes (PROs) offer valuable support. When young patients cannot offer meaningful, trustworthy self-reports on their experiences, the US Food and Drug Administration and the International Society for Pharmacoeconomics and Outcomes Research Task Force recommend the use of observer-reported outcomes. Thus, this study by Amy Paller and colleagues was to assess how dupilumab medication affected young children's quality of life and symptoms of AD as reported by patients and caregivers.

Children with moderate-to-severe AD who were 6 months to 5 years old were enrolled in the randomized, placebo-controlled LIBERTY AD PRESCHOOL trial. They were given low-potency topical corticosteroids along with either dupilumab or a placebo for 16 weeks. The change in caregiver-reported outcomes of AD symptoms (such as itching and sleep) and QoL of patients as well as their caregivers/families was evaluated in this post-hoc study between baseline and week 16.

The participants who received dupilumab showed substantial improvements in caregiver-reported AD symptoms and quality of life when compared to the ones who received a placebo. When compared to the placebo group, the dupilumab group showed a least square mean (LSM) drop of -3.6 from baseline on the Worst Scratch/Itch Numerical Rating Scale (WSI-NRS) in week 1 and maintained it through week 16.

Also, 48% of the dupilumab group satisfied the criterion for a clinically relevant change in WSI-MRS, against 9% in the placebo group. The dupilumab group improved their sleep quality numerical rating scale (NRS) by 2.0 points from baseline to week 16 when compared to a 0.3 point change in the placebo group for both individuals and caregivers. The number of patients declaring no days or 1-2 days of itching in the previous 7 days differed more in the dupilumab group from baseline than in the placebo group.

Similarly, the proportion of patients stating no days and 1-2 days of sleep disturbances in the previous 7 days differed more between week 16 and baseline. Overall, Dupilumab helped individuals with AD symptoms and their families/caregivers' quality of life.

Source:

Paller, A. S., Silverberg, J. I., Simpson, E. L., Cork, M. J., Arkwright, P. D., Chen, Z., Bansal, A., Prescilla, R., Wang, Z., & Marco, A. R. (2024). The effect of dupilumab on caregiver- and patient-reported outcomes in young children with moderate-to-severe atopic dermatitis: results from a placebo-controlled, phase 3 study. In Journal of the American Academy of Dermatology. Elsevier BV. https://doi.org/10.1016/j.jaad.2024.09.039