Lebrikizumab Pediatric Data Could Expand AD Treatment Access

Disease severity, skin clearance, and persistent itch improved for pediatric patients with moderate to severe atopic dermatitis (AD) after treatment with lebrikizumab-lbkz (Ebglyss; Eli Lilly), according to new topline data from the randomized, double‑blind, placebo‑controlled phase 3 ADorable-1 trial (NCT05559359).¹ The announcement is especially notable because as an IL-13 inhibitor, it is the only agent in its class to show such promise in pediatric patients with safety and efficacy on par with results seen among adult patients with the inflammatory skin condition.

IL-13 is a primary driver of the inflammation patients with moderate to severe AD experience.

“Despite the high prevalence of moderate to severe atopic dermatitis in infants and young children, they have fewer approved treatment options than adults and adolescents,” Amy Paller, MD, chair of the Department of Dermatology at Northwestern University and ADorable study investigator, said in a statement. “The topline results from ADorable-1 offer hope for these young patients, delivering near-complete skin clearance and significant itch relief with a highly selective medicine that targets the underlying inflammation that drives this chronic disease.”

ADorable-1 is an ongoing international investigation evaluating absorption of lebrikizumab in patients 6 months to younger than 18 years and comparing the efficacy with a control group receiving placebo.² Measured from baseline to week 16, the coprimary end points of the trial are percentage of participants with (1) Investigator Global Assessment (IGA) score 0 or 1 and a reduction of 2 points or more from baseline and (2) Eczema Area and Severity Index-75 (EASI-75) score reduction of 75% or more from baseline. Key secondary end points include EASI-90, itch relief as measured via a Pruritus Numeric Rating Score (NRS) above 4 points at baseline who achieve at least a 4-point reduction, percentage change from baseline in EASI score, and percentage change from baseline in NRS score. Patients (N = 367) received 2 weeks of topical corticosteroids (TCS) before being randomly assigned to either the treatment group, in which they received subcutaneous weight-based dosing, or the placebo group.

Lebrikizumab bested placebo across all key efficacy end points and at all doses, at rates that ranged from close to 3 times to approximately 6 times greater. In lebrikizumab cohort 1, the patient groups were 6 years to younger than 12 years, 12 years to younger than 18 years, and 6 years to younger than 18 years. In lebrikizumab cohort 2, patients were 6 months to younger than 6 years, 2 years to younger than 6 years, and 6 months to younger than 2 years. There were the efficacy results:

• EASI-75: 63% vs 22%
• IGA: 44% vs 15%
• EASI-90: 39% vs 11%
• Pruritus NRS: 35% vs 6%

Common adverse effects (AEs) of treatment with lebrikizumab were upper respiratory tract infections, nasopharyngitis, and injection site reactions, and its safety profile remained consistent with AEs seen in adult and adolescent patients. According to the current indication, the IL-13 inhibitor’s efficacy and safety in children younger than 18 years who weigh less than 88 lb (40 kg) are not yet known. If these results lead to label expansion, the 9.6 million children in the US who live with moderate to severe AD could have a new flexible treatment option.

Following an initial dose of 500 mg via two 250-mg injections, the current recommended dosing schedule is 250 mg every 2 weeks through week 16 or adequate clinical response. Subsequent dosing is 250 mg every 4 weeks, with or without TCS. Patients also have to weigh at least 88 lb to qualify for treatment.

Lilly will be submitting these data to the FDA and global regulators for potential label updates. The drug is currently approved for use in pediatric patients 12 years and older who weigh at least 88 pounds.³ It was first approved in the US in 2024.⁴

References

1. Lilly’s EBGLYSS (lebrikizumab-lbkz) is the first and only selective IL-13 inhibitor to deliver positive phase 3 outcomes in patients aged six months to 18 years with moderate-to-severe atopic dermatitis. News release. Eli Lilly. March 16, 2026. Accessed March 16, 2026. https://investor.lilly.com/news-releases/news-release-details/lillys-ebglyss-lebrikizumab-lbkz-first-and-only-selective-il-13
2. A study of lebrikizumab (LY3650150) in participants 6 months to <18 years of age with moderate-to-severe atopic dermatitis (ADorable-1). ClinicalTrials.gov. Updated January 21, 2026. Accessed March 16, 2026. https://clinicaltrials.gov/study/NCT05559359
3. Ebglyss. Prescribing information. Eli Lilly; 2025. Accessed March 16, 2026. https://pi.lilly.com/us/ebglyss-uspi.pdf
4. McCormick B. FDA approves lebrikizumab for patients aged 12 and older with moderate to severe atopic dermatitis. AJMC^®. September 16, 2024. Accessed March 16, 2026. https://www.ajmc.com/view/fda-approves-lebrikizumab-for-patients-aged-12-and-older-with-moderate-to-severe-atopic-dermatitis