AAD 2025: Clear Skin in Half of Patients Who Received Monthly Maintenance Injection of Ebglyss for AD

Raj Chovatiya, M.D., Ph.D., MSCI

Eli Lilly and Company announced on March 7, 2025, new 3-year results showing that a single monthly maintenance injection of lebrikizumab-lbkz (marketed as Ebglyss) can achieve complete skin clearance for patients with moderate-to-severe atopic dermatitis (AD) in half of those who responded to EBGLYSS monotherapy, according to a company news release.¹

These findings, drawn from the long-term extension ADjoin study, will be presented at the 2025 American Academy of Dermatology (AAD) Annual Meeting, which begins March 7 in Orlando.

Ebglyss selectively inhibits interleukin-13 (IL-13) signaling and thereby disrupts type-2 inflammatory pathways known to drive skin barrier dysfunction and associated AD symptoms.The pivotal 3-year data include Week 16 responders from the ADvocate 1 and ADvocate 2 monotherapy trials who were assessed in ADjoin while receiving Ebglyss 250 mg maintenance once monthly (or every 2 weeks).¹

Among patients receiving once-monthly therapy, 50% achieved complete skin clearance (EASI 100 or IGA 0) and 87% maintained almost-clear skin (EASI 90) at 3 years. A majority of patients (83%) did not require concomitant topical corticosteroids or topical calcineurin inhibitors during that period.¹

"Healthcare providers are constantly searching for ways to help patients achieve deep, sustainable improvement in the signs and symptoms of their atopic dermatitis," said Raj Chovatiya, M.D., Ph.D., MSCI, Clinical Associate Professor, Rosalind Franklin University Chicago Medical School, Founder and Director of the Center for Medical Dermatology + Immunology Research, in the news release. "These three-year data show that raising the bar in atopic dermatitis treatment to long-term total skin clearance was an achievable treatment goal for at least half of Ebglyss Week 16 responders, reinforcing its efficacy as a first-line biologic treatment for people with moderate-to-severe atopic dermatitis uncontrolled by topicals."¹

Ebglyss was approved in the United States in September 2024 as a first-line biologic option for moderate-to-severe AD in patients whose disease is uncontrolled by topical therapy. The approval allows clinicians to initiate Ebglyss at 250 mg every 2 weeks for approximately 4 months or until adequate clinical response is achieved, at which point maintenance dosing once monthly may be used.²

Additional data to be presented at the AAD meeting address Ebglyss in diverse patient populations. In ADmirable, a phase 3b study in patients with skin of color, nearly 60% achieved significant improvements in itch and skin pain, and over 30% reported reduced sleep loss from itch by Week 16. In ADapt, a phase 3b study of patients previously treated with dupilumab, Ebglyss led to significant improvements in skin pain and itch for 75% and 62% of participants, respectively, and 42% reported less sleep loss by Week 24.¹

"We hear from patients with moderate-to-severe atopic dermatitis that they struggle with recurring and unpredictable flares and are looking for treatment options that can provide long-term disease control," said Mark Genovese, MD, senior vice president of Lilly Immunology development, in the news release. "Ebglyss is the only first-line biologic treatment option for patients with disease uncontrolled by topicals to report completely clear skin at three years with a once-monthly maintenance dose. The additional assessments presented at AAD demonstrate significant improvements in disruptive symptoms, such as itch, across a range of patient groups."¹

Across studies, the safety profile was consistent with earlier phase 3 trials, with mild or moderate adverse events (primarily conjunctivitis and injection-site reactions) that rarely resulted in discontinuation.

Lilly holds exclusive global development and commercialization rights to Ebglyss outside Europe, where its partner Almirall retains rights for dermatologic indications including AD.

For more 2025 AAD Meeting coverage, please click here.

References

1. Eli Lilly and Company. Lilly's EBGLYSS (lebrikizumab-lbkz) single monthly maintenance injection achieved completely clear skin at three years in half of patients with moderate-to-severe atopic dermatitis. PR Newswire. Published March 7, 2025. Accessed March 7, 2025. https://prnmedia.prnewswire.com/news-releases/lillys-ebglyss-lebrikizumab-lbkz-single-monthly-maintenance-injection-achieved-completely-clear-skin-at-three-years-in-half-of-patients-with-moderate-to-severe-atopic-dermatitis-302395263.html

2. Lilly Announces FDA Approval for Lebrikizumab-lbkz of Moderate-to-severe Atopic Dermatitis. Patient Care Online. Accessed March 7, 2025. https://www.patientcareonline.com/view/lilly-announces-fda-approval-for-lebrikizumab-lbkz-of-moderate-to-severe-atopic-dermatitis.