Trial reportAdvances in therapy2025
Dupilumab Efficacy in Children with Atopic Dermatitis with Different Phenotypes and Endotypes: A Case Series.
Trial report in Advances in therapy, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03346434 (A Phase 2/3 Study Investigating the Pharmacokinetics, Safety, and Efficacy of Dupilumab in Patients Aged ≥6 Months to <6 Years With Moderate-to-Severe Atopic Dermatitis), which is not on this map. Not yet cited in PubMed.
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A Phase 2/3 Study Investigating the Pharmacokinetics, Safety, and Efficacy of Dupilumab in Patients Aged ≥6 Months to <6 Years With Moderate-to-Severe Atopic Dermatitis
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3 authors.
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Abstract
introductionAtopic dermatitis (AD) is a prevalent disease in infants and young children worldwide. Dupilumab has been shown to rapidly and significantly improve AD signs, symptoms, and quality of life in pediatric patients with moderate-to-severe AD.
methodsIn LIBERTY AD PRESCHOOL, a randomized, double-blind, placebo-controlled, phase 3 clinical trial, patients aged 6 months to 5 years with moderate-to-severe AD received subcutaneous dupilumab or matched placebo every 4 weeks for 16 weeks. All patients received concomitant low-potency topical corticosteroids. Here, we present 12 photographic cases of patients with different phenotypes and endotypes in the dupilumab group, representative of the study population, before and after treatment. Each case is presented with clinical outcome measures of AD severity and quality of life, as well as relevant biomarkers, with percent improvement from baseline.
resultsTreatment with dupilumab led to visible improvements in signs of lichenification, erythema, excoriations, skin dryness, and oozing/crusting. Clinically meaningful improvements in the measured outcomes were observed in most of the patients, including AD extent and severity, clinical lesions, itch, sleep loss, frequency of symptoms, and quality of life. These improvements were associated with substantial reductions in AD-related biomarkers.
conclusionTreatment with dupilumab improved signs, symptoms, and quality of life, and reduced AD-related serum biomarkers in young children with moderate-to-severe AD with different phenotypes and endotypes.
trial registrationThe trial was registered with ClinicalTrials.gov with ID number NCT03346434 on November 17, 2017. Video abstract available for this article. Video abstract (MP4 1,02,609 KB).
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