Dupilumab Effective in Young Children with Atopic Dermatitis, Comorbid T2 Inflammatory Disease

In young children aged 6 months to 5 years, treatment with dupilumab reduced the signs and symptoms of moderate-to-severe atopic dermatitis regardless of concomitant type 2 inflammatory conditions including asthma, allergic rhinitis, or food allergies, according to a post hoc analysis of the LIBERTY AD PRESCHOOL part B clinical trial.¹

Led by Mark Boguniewicz, MD, professor, pediatrics-allergy, immunology, rheumatology at University of Colorado Anschutz Medical Campus and a pediatric allergist and immunologist at National Jewish Health in Denver, CO, investigators reported that following 16 weeks of treatment significantly more participants treated with dupilumab vs placebo, with or without asthma and allergic rhinitis, achieved an Investigator’s Global Assessment (IGA) score of 0 or 1 and a 75% or greater improvement in Eczema Area and Severity Index (EASI) (all P < .05).¹ Significantly more children receiving dupilumab who had food allergies and numerically more who received the study drug but did not have food allergies reached an IGA score of 0 or 1 (P = .001 and P = .06, respectively).¹

In analyses of the weekly average of daily score on the Worst Scratch/Itch Numeric Rating Scale (WSI-NRS), Boguniewicz and colleagues found that numerically more participants receiving dupilumab vs placebo with asthma and significantly more patients without asthma achieved a 4 point or greater reduction (P = .60 and P < .001, respectively). Further, significantly more participants treated with dupilumab vs placebo with or without allergic rhinitis and with or without food allergies reached the same reduction on the WSI-NRS.¹

The overall safety of dupilumab in the study was consistent with the drug’s known safety profile and similar across active treatment and placebo groups, according to the study. The findings were published in the Journal of Advanced Therapy.¹

AD and Dupilumab

Global prevalence of atopic dermatitis among children aged 6 months to 5 years is estimated to be 12%.^2,3 Moderate-to-sever disease in infants and young children is characterized by skin lesions and intense pruritis. Resulting sleep disturbance affects quality of life for the child and also for family and caregivers.^2,3 Comorbid type 2 inflammatory disease is common in the pediatric population, according to the study authors. They cite data estimating that 16% to 30% also have asthma, 23% to 33% have allergic rhinitis, and approximately one-third (33%) to more than one-half (56%) have concomitant food allergies.¹

Dupilumab is associated with significant efficacy and an “acceptable” safety record in both adults and children with moderate to severe atopic dermatitis, the authors noted. In adults the interleukin (IL)-4 and IL-13 receptor antagonist has also demonstrated efficacy in subgroups with comorbid asthma or sinonasal conditions consistent with that seen in the overall study population. The current study was designed to provide similar data on the impact of comorbid type 2 conditions on dupilumab efficacy in infants and young children, an outcome yet to be explored.¹

LIBERTY AD PRESCHOOL part B

In the original LIBERTY AD PRESCHOOL part B study, dupilumab vs placebo in combination with low-potency topical corticosteroids significantly improved signs and symptoms of atopic dermatitis as well as quality of life in children aged 6 months to 5 years with moderate-to-severe atopic dermatitis. In the double-blind placebo controlled, phase 3 clinical trial 162 participants were randomly assigned to receive dupilumab either with (n = 83) or without (n = 79) topical corticosteroids. The children had a mean age of 3.1 years and 61% were boys. Overall, 99% of the participants had at least 1 atopic comorbidity at baseline: 26% had asthma; 44% had allergic rhinitis; and 68% had various food allergies. The prevalence of each was similar between the dupilumab and placebo groups, according to the study.

Results of the post hoc analysis are consistent with and reinforce those of earlier studies showing the efficacy of dupilumab for treatment of atopic dermatitis with comorbid type 2 inflammatory comorbidities, authors wrote. Further, the monoclonal antibody has been shown superior to placebo in decreasing the incidence rate ratio for the risk of new, or worsening of preexisting, allergic conditions in both adults and adolescents with atopic dermatitis, they added. “Asthma and [allergic rhinitis] can develop after the onset of [atopic dermatitis] in young children as part of the atopic march. Early treatment of young children with dupilumab may offer a method for disease modification by preventing the advancement of the atopic march,” Boguniewicz et al concluded.¹

Among the study’s limitations the authors note the low number of participants between ages 6 months and younger than 2 years, which may limit generalizability of the findings. Also, the report of comorbidities by caregivers may be subject to bias and thus may have affected reliability of the results.¹

References:

1. Boguniewicz M, Sher LD, Paller AS, et al. Dupilumab is efficacious in young children with atopic dermatitis regardless of type 2 comorbidities. Adv Ther. 2024;41:4601-4616. doi:10.1007/s12325-024-02998-4

2. Yang EJ, Beck KM, Sekhon S, Buhtani T, Koo J. The impact of pediatric atopic dermatitis on families: a review. Pediatr Dermatol. 2019;36(1):66-71. doi: 10.1111/pde.13727

3. Chamlin SL, Chren M-M. Quality-of-life outcomes and measurement in childhood atopic dermatitis. Immunol Allergy Clin North Am. 2010;30(3):281–8. https://doi.org/10.1016/j.iac.2010.05.004.