Dupilumab Improves Sleep, Itch, and Other QoL Measures in Children With Eczema

Amy S. Paller, MS, MD

Credit: Northwestern

Dupilumab improved symptoms of atopic dermatitis (AD) and quality of life (QoL) in pediatric patients and their caregivers/families.¹

“Many symptoms (eg, pruritus, sleep disturbance) are difficult for clinicians to assess.² Patient reported outcomes (PROs) provide an important complement to clinician-reported outcomes. The US Food and Drug Administration and the International Society for Pharmacoeconomics and Outcomes Research Task Force support using observer-reported outcomes when young patients cannot provide reliable, valid, self-reported responses about their experiences,” lead investigator Amy S. Paller, MS, MD, Chair, Department of Dermatology, and Director, Skin Biology and Diseases Resource-Based Center, and Walter J. Hamlin Professor of Dermatology, Northwestern University Feinberg School of Medicine, and colleagues.¹

The new findings are reported from a post-hoc analysis of the randomized, placebo-controlled LIBERTY AD PRESCHOOL study. The study enrolled children between the age of 6 months and 5 years with moderate-to-severe AD that received dupilumab or placebo plus low-potency topical corticosteroids for 16 weeks. Paller and colleagues assessed the change from baseline to week 16 in caregiver-reported outcome measures of AD symptoms, including itch and sleep, and QoL of patients and their caregivers/families.

The investigators found that participants treated with dupilumab (n = 83) experienced significant improvements in caregiver-reported AD symptoms and QoL compared with those that received placebo (n = 79). The dupilumab group had a least square mean (LSM) change of -3.6 (95% CI, -4.33 to -3.23) from baseline on Worst Scratch/Itch Numerical Rating Scale (WSI-NRS) as week 1 and sustained through week 16 compared with the placebo group (LSM, -0.6 [95% CI, -1.16 to -0.01]; P < .0001). Furthermore, 48% of the dupilumab group met the criteria for a clinically meaningful change in WSI-MRS compared with 9% in the placebo group (P < .0001).¹

The dupilumab group had an improvement of 2.0 (95% CI, 1.55-2.53) on sleep quality numerical rating scale (NRS) from baseline to week 16 compared with a change of 0.3 (95% CI, -0.17 to 0.84; P <.0001) in the placebo group for participants as well as for caregivers (1.8 [95% CI, 1.26-2.25] vs 0.3 [95% CI, −0.26 to 0.76], respectively).¹

Improvements in Patient-Oriented Eczema Measure (POEM) were also greater in the dupilumab group (-12.9 [95% CI, -14.6 to -11.1]) than the placebo group (-3.8 [95% CI, -5.6 to -2.0]; P <.0001) at week 16, with 61% of patients of the dupilumab group achieving at least a 6-point improvement compared with 19% of the placebo group.

The dupilumab group also had a greater difference in the proportion of patients reporting no days (+3.5%) or 1-2 days (+28.9%) itchy in the last 7 days from baseline compared with the placebo group (+2.5% and +3.8%, respectively), as was the difference between week 16 and baseline in proportion of patients reporting no days and 1-2 days of the previous 7 days with sleep disturbances (no days, +25.3% vs +2.5% and 1-2 days, +38.6% vs +20.3%, respectively).¹

On Infants' Dermatitis Quality of Life Index (IDQoL), the dupilumab group had an LSM of 6.3 (95% CI, 4.04-8.58) compared with 15.3 (95% CI, 13.16-17.38; P <.0001) in the placebo group. Similarly, a greater proportion of the dupilumab group achieved at least a 6-point improvement on Children’s Dermatology Life Quality Index (CDLQI) score (66%) and IDQoL score (65%), and at least a 7-point improvement in Dermatitis Family Impact (DFI) score (59%) than placebo (16%, 6%, and 16%, respectively).¹

“Short-term consequences of sleep disruption include increased stress responsivity, reduced QoL, and emotional distress in otherwise healthy individuals, and may diminish health-related QoL of children/adolescents with underlying medical conditions. Sleep disturbances in children are associated with decreased neurobehavioral functioning, higher rates of behavioral problems, and reduced cognitive performance. Therefore, it is important for healthcare professionals to treat symptoms of underlying medical conditions effectively to optimize sleep continuity. Improvements in sleep quality during dupilumab treatment benefit children with AD and their families,” Paller and colleagues wrote.¹

“Future studies should explore long-term follow-up to confirm sustained improvement in 300 QoL scores and sleep beyond 16 weeks of treatment,” they concluded.¹

REFERENCES
1. Paller AS, Silverberg JI, Simpson EL, et al. 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. J Am Acad Dermatol. Published online September 28, 2024. doi:10.1016/j.jaad.2024.09.039

2. Townshend AP, Chen CM, Williams HC. How prominent are patient-reported outcomes in clinical 344 trials of dermatological treatments? Br J Dermatol. 2008;159(5):1152-1159. 345 https://doi.org/10.1111/j.1365-2133.2008.08799.x