Dupilumab treatment reduces caregiver-reported skin pain in patients with moderate-to-severe atopic dermatitis aged 6 months to 5 years.

Background: Moderate-to-severe atopic dermatitis (AD) often has a profound impact on the quality of life of young children and their caregivers. One of the most burdensome symptoms reported by patients is skin pain.
Methods: This post hoc analysis focuses on the impact of dupilumab treatment on skin pain in young children using data from the LIBERTY AD PRESCHOOL part B (NCT03346434), a 16-week randomized, double-blind, placebo-controlled, phase 3 study in 162 children aged 6 months to 5 years with moderate-to-severe AD receiving dupilumab or placebo, plus topical corticosteroids (TCS). Analyses were performed on the full analysis set and subgroups of patients who did not achieve an Investigator's Global Assessment score of 0 or 1 (IGA >1 subgroup), or who did not achieve a 75% improvement from baseline in the Eczema Area and Severity Index (<EASI-75 subgroup), at week 16 (patients who did not achieve the primary or key secondary endpoints in LIBERTY AD PRESCHOOL part B).
Results: At week 16, change from baseline in the skin pain NRS was significantly greater in the dupilumab group vs. the placebo group (-3.93 vs. -0.62, p  < 0.0001) and significantly more patients receiving dupilumab vs. placebo achieved a clinically meaningful improvement at week 16 (47.2% vs. 10.8%, p  < .0001). Similar results between dupilumab vs. placebo were seen in the two subgroups IGA >1 and <EASI-75.
Conclusions: This analysis showed rapid, clinically meaningful, and statistically significant improvements in skin pain in patients treated with dupilumab plus TCS vs. placebo plus TCS.
Competing Interests: ASP: AbbVie, Applied Pharma Research, Dermavant, Eli Lilly, Incyte, Janssen, Krystal Biotech, Regeneron Pharmaceuticals Inc., Timber, UCB – investigator; AbbVie, Abeona Therapeutics, Apogee Therapeutics, Arcutis Biotherapeutics, Aslan Pharmaceuticals, BioCryst, Boehringer Ingelheim, Bristol Myers Squibb, Dermavant, Incyte, Johnson & Johnson, Krystal Biotech, LEO Pharma, Mitsubishi Tanabe, Nektar Therapeutics, Primus, Procter & Gamble, Regeneron Pharmaceuticals Inc., Sanofi, Seanergy, TWI Biotech, UCB – consultant; AbbVie, Abeona Therapeutics, Galderma – data and safety monitoring boards. JIS: AbbVie, AnaptysBio, Alamar Biosciences, Aldena Therapeutics, Amgen, AOBiome, Arcutis Biotherapeutics, Arena, Asana BioSciences, Aslan Pharmaceuticals, BiomX, Biosion, Bodewell, Boehringer Ingelheim, Bristol Myers Squibb, Cara Therapeutics, Castle Biosciences, Celgene, Connect Biopharma, CorEvitas, Dermavant, Dermira, DermTech, Eli Lilly, Galderma, Glenmark, GlaxoSmithKline, Incyte, Kiniksa Pharmaceuticals, LEO Pharma, MedImmune, Menlo Therapeutics, Novartis, Optum, Pfizer, PuriCore, RAPT Therapeutics, Recludix Pharma, Regeneron Pharmaceuticals Inc., Sanofi, Shaperon, Target RWE, Union therapeutics, UpToDate – consultant and/or advisory board member; AbbVie, Eli Lilly, LEO Pharma, Pfizer, Regeneron Pharmaceuticals Inc., Sanofi – speaker; Galderma, Incyte, Pfizer – grants. MEG: AbbVie, Arcutis Biotherapeutics, Amgen, Anterogen, Dermavant, Eli Lilly, Incyte, Krystal Biotech, Neilsen Biosciences, Novartis, Regeneron Pharmaceuticals Inc., Sanofi – investigator; Abeona Therapeutics, Arcutis Biotherapeutics, Alphyn Biologics, Dermavant, Eli Lilly, Incyte, Krystal Biotech, Verrica Pharmaceuticals – consultant; AbbVie, Eli Lilly, Krystal Biotech, Pfizer, Regeneron Pharmaceuticals Inc., Sanofi, Verrica Pharmaceuticals – speakers bureau. LCS: Regeneron Pharmaceuticals Inc. – investigator; Pfizer – grant; AbbVie, Division of Allergy, Immunology, and Transplantation (DAIT)/National Institute for Allergy and Infectious Diseases (NIAID), LEO Pharma, Regeneron Pharmaceuticals Inc., Sanofi, Triveni Bio – advisory boards. RS: Castle Biosciences, Galderma, Pfizer, Regeneron Pharmaceuticals Inc., UCB – investigator; Beiersdorf – speaker; Arcutis Biotherapeutics, Dermavent, LEO Pharma, Lilly – consultant. ZC, AB, ZW: Regeneron Pharmaceuticals Inc. – employees of and shareholders in the company. RP: Sanofi – employee of and may hold stock and/or stock options in the company.
(© 2024 Paller, Silverberg, Gonzalez, Schneider, Sidbury, Chen, Bansal, Wang and Prescilla.)