Lilly's EBGLYSS™ (lebrikizumab-lbkz) Maintains Disease Control for 3 Years in Most Atopic Dermatitis Patients

More than 80% of adults and adolescents with moderate-to-severe atopic dermatitis who responded to the EBGLYSS™ treatment at Week 16 in the ADvocate 1 and 2 monotherapy trials and continued treatment for up to three years experienced sustained skin clearance with monthly maintenance dosing. Eli Lilly and Company announced these new long-term results from the ADjoin long-term extension study, which will be presented at the European Academy of Dermatology and Venereology (EADV) Congress in Amsterdam, Netherlands.

EBGLYSS is an interleukin-13 (IL-13) inhibitor that selectively blocks IL-13 signaling with high binding affinity. The cytokine IL-13 is key in atopic dermatitis, driving the type-2 inflammatory cycle in the skin, leading to skin barrier dysfunction, itch, skin thickening, and infection.

"The chronic and persistent signs and symptoms of atopic dermatitis affect patients' daily lives, highlighting the need for a treatment that can provide sustained, long-term relief," said Eric Simpson, M.D., M.C.R., professor of dermatology and director of clinical research at Oregon Health & Science University School of Medicine. "These three-year results provide compelling evidence of durable efficacy and a consistent safety profile, offering further long-term evidence for health care providers seeking a new biologic treatment option for their patients."

Patients taking EBGLYSS who completed 52 weeks in ADvocate 1 or 2 could enroll in ADjoin for an additional 100 weeks of continued treatment (up to 152 weeks of continuous treatment). Patients in this analysis of the long-term extension trial received treatment either 250 mg every two weeks (Q2W) or once monthly (Q4W). The approved maintenance dose of EBGLYSS is 250 mg Q4W. These data presented are part of ADjoin, the long-term extension study of the EBGLYSS trials, and include participants who responded to EBGLYSS treatment at Week 16 from ADvocate 1 and ADvocate 2.

The results showed that 84% of patients taking EBGLYSS once monthly and 83% taking EBGLYSS every two weeks maintained clear or almost-clear skin (IGA 0,1) at three years. Additionally, 87% of patients taking EBGLYSS once monthly and 79% taking it every two weeks achieved or maintained at least a 90% improvement in disease extent and severity (EASI-90) at three years. Furthermore, 83% of once-monthly and 91% of every-two-weeks patients did not require either high-potency topical corticosteroids or systemic treatments.

The safety profile of these patients taking EBGLYSS in ADjoin was consistent with previous EBGLYSS studies, and no new safety signals were observed up to three years of treatment. The majority of adverse events were mild or moderate, with less than three percent of patients experiencing adverse events leading to treatment discontinuation. The most common side effects of EBGLYSS were conjunctivitis, injection site reactions, and shingles (herpes zoster).

"Without adequate treatment, atopic dermatitis can leave people struggling with uncontrolled symptoms," said Mark Genovese, M.D., senior vice president of Immunology Development at Lilly. "EBGLYSS selectively targets IL-13, one of the main drivers of inflammation in eczema. These three-year data demonstrate that EBGLYSS given once monthly provides durable symptom relief for patients who need it most."

Additional data from this clinical study is underway, with results to be presented at future congresses. EBGLYSS was approved in the U.S. by the Food and Drug Administration (FDA) earlier this month. EBGLYSS was also approved in the European Union in 2023 and in Japan in January 2024, with additional markets expected later this year.

"These latest clinical data for EBGLYSS show the potential of this innovative medicine to provide sustained improvement of moderate-to-severe atopic dermatitis, a chronic and often debilitating condition," said Volker Koscielny, M.D., Chief Medical Officer at Almirall. "The data can help inform clinical decision-making and are reassuring, as they show that the vast majority of patients who respond to the treatment will continue to respond over time."

Lilly has exclusive rights for development and commercialization of EBGLYSS in the U.S. and the rest of the world outside Europe. Lilly's partner Almirall has licensed the rights to develop and commercialize EBGLYSS for the treatment of dermatology indications, including eczema, in Europe.