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Randomized Controlled Trial
. 2024 Dec;41(12):4601-4616.
doi: 10.1007/s12325-024-02998-4. Epub 2024 Oct 29.

Dupilumab is Efficacious in Young Children with Atopic Dermatitis Regardless of Type 2 Comorbidities

Mark Boguniewicz  1   2 , Lawrence D Sher  3 , Amy S Paller  4 , Peter D Arkwright  5 , Shigemi Yoshihara  6 , Zhen Chen  7 , Parul Shah  7 , Ainara Rodríguez Marco  8
Affiliations
Randomized Controlled Trial

Dupilumab is Efficacious in Young Children with Atopic Dermatitis Regardless of Type 2 Comorbidities

Mark Boguniewicz et al. Adv Ther. 2024 Dec.

Abstract

Introduction: Patients with atopic dermatitis (AD) often have other comorbid type 2 inflammatory conditions. The aim of this study was to evaluate the impact of type 2 comorbidities on the response to and safety of dupilumab in young children with AD.

Methods: LIBERTY AD PRESCHOOL part B was a randomized, placebo-controlled trial in children aged 6 months to 5 years with moderate-to-severe AD. In this post hoc analysis, patients were stratified by the presence or absence of caregiver-reported selected type 2 comorbidities at baseline: asthma, allergic rhinitis (AR), and food allergies (FAs).

Results: At week 16, significantly more patients receiving dupilumab versus placebo, with or without asthma and AR, achieved an Investigator's Global Assessment (IGA) score of 0/1 and a ≥ 75% improvement in Eczema Area and Severity Index (all p < 0.05). Significantly more patients receiving dupilumab versus placebo with FAs and numerically more patients without FAs achieved an IGA score of 0/1 (p = 0.0007 and p = 0.06). Numerically more patients receiving dupilumab versus placebo with asthma and significantly more patients without asthma achieved a ≥ 4-point reduction in the weekly average of daily score on the Worst Scratch/Itch Numeric Rating Scale (WSI-NRS) (p = 0.6 and p < 0.0001). Additionally, significantly more patients receiving dupilumab versus placebo with or without AR (p = 0.008 and p < 0.0001) and with or without FAs (p = 0.0002 and p = 0.004) achieved a ≥ 4-point reduction in the weekly average of daily score on the WSI-NRS. Overall safety was consistent with the known dupilumab safety profile.

Conclusions: Dupilumab treatment improves AD signs and symptoms in children aged 6 months to 5 years with and without type 2 comorbidities such as asthma, AR, and FAs.

Trial registration: ClinicalTrials.gov registration number NCT03346434.

Infographic: Do type 2 comorbidities impact the response to dupilumab in children with atopic dermatitis? (MP4 103,451 KB).

Keywords: Atopic dermatitis; Comorbidities; Dupilumab; Pediatrics; Type 2 inflammation.

Plain language summary

Patients with atopic dermatitis (AD; also known as eczema) often have other inflammatory conditions as well, including asthma, allergic rhinitis, and food allergies. Like AD, they are all so-called type 2 conditions, caused by similar processes in the body. A drug called dupilumab has been shown to be effective in treating patients with moderate-to-severe AD. This study looked at the results of a clinical trial in which children aged 6 months to 5 years with moderate-to-severe AD had been treated with either dupilumab or placebo for 16 weeks. The trial results had already shown that at the end of the study, dupilumab compared with placebo resulted in better improvements in their disease and quality of life. In this study, we looked at patients who had only AD, and those who had AD plus one of the other type 2 conditions. We wanted to know if the conditions would impact the response to dupilumab in children with AD. Results showed that dupilumab was better than placebo at reducing the signs and the symptoms of AD in patients, whether or not they also had asthma, allergic rhinitis, or food allergies. Overall safety was consistent with the known dupilumab safety profile. In summary, dupilumab improves the signs and symptoms of moderate-to-severe AD in children aged 6 months to 5 years whether or not they also have another type 2 condition. These results suggest that dupilumab treatment may be effective in children with or without other type 2 conditions.

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Conflict of interest statement

Mark Boguniewicz has been an investigator for Incyte, Regeneron Pharmaceuticals Inc., and Sanofi, and participated on advisory boards for AbbVie, Amgen, Dermavant, Eli Lilly, Incyte, LEO Pharma, Pfizer, Regeneron Pharmaceuticals Inc., and Sanofi. Lawrence D. Sher is an advisory board member for Aimmune Therapeutics, Optinose, Regeneron Pharmaceuticals Inc., and Sanofi; reports speaker fees from Regeneron Pharmaceuticals Inc. and Sanofi; and clinical trials funding from Aimmune Therapeutics, Amgen, AstraZeneca, Circassia, DBV Technologies, Galderma, GSK, Lupin, Merck, Mylan, Novartis, Novo Nordisk, Optinose, Pearl, Pfizer, Pulmagen, Roxane, Sanofi, Spirometrix, Teva, Vectura, and Watson Pharmaceuticals. Amy S. Paller is an investigator for AbbVie, Dermavant, Eli Lilly, Incyte, Janssen, Krystal Biotech, LEO Pharma and UCB; a consultant for Amryt Pharma, Azitra, BioCryst, BMS, Boehringer Ingelheim, Castle Creek Biosciences, Eli Lilly, Janssen, Krystal Biotech, LEO Pharma, Novartis, Regeneron Pharmaceuticals Inc., Sanofi, Seanergy, TWi Biotechnology, and UCB; and a member of the data and safety monitoring board for AbbVie, Abeona Therapeutics, Catawba Research, Galderma, and InMed Pharmaceuticals. Peter D. Arkwright has acted as an investigator for Regeneron Pharmaceuticals Inc., and has received grants from and acted as an advisor for Sanofi. Shigemi Yoshihara has acted as an investigator for Regeneron Pharmaceuticals Inc., and has received grants from and acted as an advisor for Sanofi. Zhen Chen and Parul Shah are employees and shareholders of Regeneron Pharmaceuticals Inc. Ainara Rodríguez Marco is an employee of and may hold stock and/or stock options in Sanofi.

Figures

Fig. 1
Fig. 1
Proportion of patients achieving an IGA score of 0/1 at week 16, with and without a asthma, b AR, c FAs. n.s. not significant; AR allergic rhinitis; FA food allergies; IGA Investigator’s Global Assessment; q4w every 4 weeks; TCS topical corticosteroid
Fig. 2
Fig. 2
Proportion of patients achieving EASI-75 at week 16, with and without a asthma, b AR, c FA. AR allergic rhinitis; FA food allergies; EASI-75≥ 75% improvement in Eczema Area and Severity Index; q4w every 4 weeks; TCS topical corticosteroid
Fig. 3
Fig. 3
Proportion of patients achieving ≥ 4-point reduction of WSI-NRS score at week 16, with and without a asthma, b AR, c FA. AR allergic rhinitis; FA food allergies; N1 number of patients with baseline WSI-NRS score ≥ 4; WSI-NRS Worst Scratch/Itch Numeric Rating Scale; q4w every 4 weeks; TCS topical corticosteroid
See this image and copyright information in PMC

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