ADorable-1 Trial Meets Endpoints for EBGLYSS in Children With Atopic Dermatitis

Key Takeaways

• Phase 3 ADorable-1 results showed EBGLYSS (lebrikizumab-lbkz) significantly improved skin clearance and itch in pediatric patients with moderate-to-severe atopic dermatitis.

• At Week 16, 63% of treated patients achieved EASI-75 and 44% reached clear or almost clear skin (IGA 0/1).

• Lilly plans to submit the data to regulators for a potential label expansion in pediatric patients aged 6 months to 18 years.

Eli Lilly and Company announced positive topline results from the phase 3 ADorable-1 trial of lebrikizumab-lbkz (Ebglyss) in pediatric patients aged 6 months to 18 years with moderate-to-severe atopic dermatitis (AD), showing the therapy meeting its primary and secondary endpoints at week 16.

In ADorable-1, participants were randomized to receive placebo or weight-based dosing of lebrikizumab. Topical corticosteroids were required beginning 2 weeks prior to randomization and throughout the 16-week treatment period, with an option to taper or discontinue once patients achieved an Investigator’s Global Assessment (IGA) score of 2 or less. At week 16, 63% of patients treated with lebrikizumab achieved at least a 75% reduction in Eczema Area and Severity Index score (EASI-75) vs 22% for placebo. Clear or almost clear skin (IGA 0 or 1 with a ≥2-point improvement from baseline) was reported in 44% of treated patients vs 15% placebo. Higher thresholds of response were also achieved, with About 39% of patients acheived EASI-90 vs 11% placebo. Clinically meaningful itch reduction occurred in 35% of lebrikizumab-treated patients vs 6% for placebo.

The safety profile of lebrikizumab was consistent with previous findings from adult and adolescent trials. 

"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," said Amy Paller, MD, chair of dermatology at Northwestern University and an investigator in the ADorable study, in a press release. "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."

Additional findings from ADorable-1 and ADorable-2 are expected later this year.

Source: Lily press release.