ADjoin: Phase 3 Findings Released on Lebrikizumab (Ebglyss) for Atopic Dermatitis

Lebrikizumab-lbkz (Ebglyss) treatment of moderate-to-severe atopic dermatitis results in durable disease control when used once every 8 weeks (Q8W), new data suggest.1

These findings, presented at the 2025 Fall Clinical Dermatology conference, were announced by Eli Lilly, highlighting the potential for a less frequent dosing regimen when using lebrikizumab in atopic dermatitis. The data were the result of the phase 3 ADjoin extension trial (NCT04392154).

"For people managing the persistent symptoms of eczema, hesitancy about frequent injections can add to the already heavy toll of this disease," Peter Lio, MD, ADjoin author and clinical assistant professor of dermatology and pediatrics at Northwestern University, said in a statement.1 "With as few as six maintenance doses per year, EBGLYSS would give patients and providers more flexibility, which may reduce treatment burden for patients with busy lives."

Lebrikizumab is a monoclonal antibody designed to selectively inhibit interleukin-13 (IL-13) signaling with high binding affinity. IL-13 plays a central role in the pathogenesis of atopic dermatitis, promoting type-2 inflammation and contributing to itch, issues with the skin barrier, lichenification, and susceptibility to different infections.2,3

In this Q8W extension of the ADjoin study, Lio and colleagues looked at the long-term safety and efficacy of lebrikizumab administered Q8W versus every 4 weeks (Q4W) for a total of 32 weeks, evaluating individuals with moderate-to-severe atopic dermatitis in select countries.1 Those eligible to take part included adults and adolescents aged 12-17 years (≥40 kg) who had finished the 100-week ADjoin study or previous lebrikizumab research, including ADvocate 1 and 2 (52 weeks), ADore (52 weeks), and ADopt-VA (16 weeks).

Open-label lebrikizumab 250 mg was administered to study subjects in this extension either Q8W or Q4W, regardless of any prior dosing regimen (Q2W or Q4W). Overall, the investigative team observed comparable efficacy between dosing regimens, noting skin clearance levels had been maintained with 250 mg administered Q8W and consistent outcomes with those attained via monthly dosing.1

The team highlighted findings showing 79% of participants were treated with lebrikizumab every other month and 86% of those on monthly dosing achieved or maintained 75% improvement in Eczema Area and Severity Index scores (EASI-75), while 62% and 73%, respectively, attained or maintained an Investigator's Global Assessment (IGA) score of 0 or 1.

Lio et al further noted a lack of increased incidence of immunogenicity, with no new safety signals being observed during ADjoin. The data suggest that an every-8-week dosing schedule may provide clinicians and patients with an effective, lower-frequency maintenance option for treatment with lebrikizumab.

The data also reinforce previous findings demonstrating the durability of lebrikizumab’s efficacy for up to 3 years and its effectiveness across a diverse range of patient skin tones. Lebrikizumab can also be prescribed with or without topical agents, noted as a key consideration for both dermatologists and payers.

Findings in the ADjoin Q8W extension have been submitted by Eli Lilly, along with additional supporting data, to the US Food and Drug Administration (FDA) for a potential label update.1 A separate analysis is ongoing to assess lebrikizumab 500 mg administered once every 12 weeks (Q12W) as a potential maintenance regimen.

References

1. Lilly's EBGLYSS (lebrikizumab-lbkz) delivered durable disease control when administered once every eight weeks in patients with moderate-to-severe atopic dermatitis. Eli Lilly. October 24, 2025. https://investor.lilly.com/news-releases/news-release-details/lillys-ebglyss-lebrikizumab-lbkz-delivered-durable-disease.

2. Bieber T. Interleukin-13: Targeting an underestimated cytokine in atopic dermatitis. Allergy. 2020;75(1):54–62. doi:10.1111/all.13954. Accessed October 24, 2025.

3. Tsoi LC, et al. Atopic Dermatitis Is an IL-13-Dominant Disease with Greater Molecular Heterogeneity Compared to Psoriasis. J Invest Dermatol. 2019;139(7):1480-1489. doi:10.1016/j.jid.2018.12.018. Accessed October 24, 2025.