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New phase 3 ADorable-1 data show lebrikizumab improved skin clearance in children with moderate-to-severe atopic dermatitis.
The growing armamentarium of treatments for pediatric atopic dermatitis continues to generate new data available for clinicians managing moderate-to-severe cases of this skin disease.
In conversation with HCPLive at the Society for Pediatric Dermatology (SPD) Annual Meeting, Lawrence Eichenfield, MD, discussed findings from the phase 3 ADorable-1 trial evaluating lebrikizumab in patients aged 6 months to younger than 18 years.1,2 He highlighted both the study's design and the efficacy outcomes, emphasizing the potential role of the therapy in younger patient populations.
“Their initial approval was 12 years of age and older and [for] context, we know right now the only approved systemic biologic agent for atopic dermatitis under 12 is to is dupilumab,” Eichenfield explained.
Eichenfield noted that the pediatric study builds on previous work evaluating lebrikizumab in adolescents, where the therapy was initially approved for patients aged 12 years and older. The ADorable-1 trial expanded the evaluation to include infants, children, and adolescents, enrolling patients from 6 months through 17 years of age.
Participants were divided into age-based cohorts, with one including children aged 6 months to younger than 2 years and another spanning older pediatric patients through adolescence.
According to Eichenfield, ADorable-1 was conducted as a randomized, placebo-controlled trial in which all participants received background topical corticosteroid therapy. He described this design as reflecting ethical considerations in pediatric research, ensuring that children in the placebo group still received active topical medications rather than remaining untreated.
Following a two-week run-in period with topical corticosteroids, participants were randomized to receive weight-based lebrikizumab plus topical corticosteroids or placebo plus topical corticosteroids for 16 weeks. Patients who achieved clear skin were permitted to taper topical corticosteroid use and transition to moisturizers alone.
Eichenfield emphasized that the trial enrolled a population with substantial atopic dermatitis burden. Approximately one-quarter of participants had severe disease at baseline, while the remainder met criteria for moderate disease.
Patients also presented with a mean Eczema Area and Severity Index (EASI) score of approximately 28 and nearly half of their body surface area affected, underscoring the severity of disease within the study population.
By the 16-week mark, the study demonstrated clinically meaningful improvements across multiple efficacy endpoints. Among patients receiving lebrikizumab, 43.5% attained clear or almost clear skin compared with 15.0% of those receiving placebo plus topical corticosteroids. Similarly, 62.6% achieved EASI-75 versus 21.6% in the placebo arm of the trial.
Eichenfield also highlighted higher-threshold responses, including EASI-90 in 38.6% of treated patients and complete skin clearance (EASI-100) in 13.7%, describing the separation between treatment groups as encouraging for clinicians caring for pediatric patients with moderate-to-severe atopic dermatitis.
Disclosures: Eichenfield previously reported receiving personal fees from Pfizer Inc; grant funding from AbbVie, Arcutis Biotherapeutics, Bausch + Lomb, Castle Biosciences, Dermavant Sciences Inc, Galderma SA, Pfizer Inc, Regeneron, and Sanofi SA and consulting for ASLAN Pharmaceuticals, AbbVie, Almirall, SA, Arcutis Biotherapeutics, Arena Pharmaceuticals Inc, Dermavant Sciences Inc, Galderma SA, Incyte Corporation, LEO Pharma A/S, Eli Lilly and Company, Ortho Dermatologics, Pfizer Inc, Regeneron Pharmaceuticals Inc, Sanofi SA, and UCB; and serving on the board of directors of Forté Pharma.
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