Dupilumab safe, effective for up to 1 year for atopic dermatitis in infants, preschool children

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According to new study data presented at the 2024 Pediatric Academic Societies Meeting, dupilumab (dupixent; Sanofi and Regeneron) demonstrated positive safety and efficacy results for up to 1 year in infants and preschool-age children with atopic dermatitis.

Infant boy with atopic dermatitis

Image credit: © Olga Sidel'nikova - stock.adobe.com

Atopic dermatitis (AD) is a prevalent inflammatory skin condition among children, and in individuals with moderate-to-severe disease, there are significant challenges for long-term management. However, a recent study presented at the 2024 Pediatric Academic Societies Meeting has shed light on a promising treatment option for children aged from 6 months to 5 years with moderate-to-severe AD.

In the study, investigators focused on evaluating the efficacy and safety of dupilumab over a period of 1 year in this patient population.

The study (NCT02612454) enrolled children who had participated in the LIBERTY AD PRESCHOOL trial (NCT03346434, part B; parent study), which was a 16-week double-blind phase 3 trial. Dupilumab was administered to participants subcutaneously every 4 weeks, with dosage varying based on the weight of the children.

The results of the study demonstrated significant improvements in various markers of AD severity and quality of life.

Key findings include:

  • Reduction in eczema severity: Mean percentage changes in EASI score in the 200 mg and 300 mg dupilumab groups were −52.7(5.5) and −56.6 (3.4) at OLE baseline, −81.0(3.3) and −82.6(1.8) at week 16, and −87.6(3.7) and −86.2(2.6) at week 52, respectively.
  • Improvement in Investigator’s Global Assessment (IGA) score: In the 200 mg and 300 mg dupilumab groups, IGA score of 0/1 increased from OLE baseline (6/39[15.4] and 15/103[14.6]), to week 16 (17/38[44.7] and 33/101[32.7]), and at week 52 (7/17[41.2] and 14/41[34.1]), respectively.
  • Enhancement in quality of life: Both the Children’s Dermatology Life Quality Index and Infant Dermatitis Quality of Life Index showed meaningful improvements, signifying a positive impact on the patients' quality of life.
  • Safety profile: The safety profile of dupilumab treatment remained consistent with its known safety profile, indicating an acceptable safety profile for up to one year of treatment.

The investigators concluded that up to 1 year of dupilumab treatment provide sustained improvement in AD symptoms and quality of life for children aged 6 months to 5 years with moderate-to-severe disease. Additionally, dupilumab appears to have an acceptable safety profile, offering hope for better management of this challenging condition in young children, according to the investigators.

Reference:

Paller AS, Siegfried EC, Xiao J, Prescilla R, Bansal A. 336 Efficacy of dupilumab in infants and preschoolers with atopic dermatitis up to 1 year. British Journal of Dermatology. 2023;188(Supplement_2):ljac140.030. doi:10.1093/bjd/ljac140.030

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