Lebrikizumab Demonstrates Sustained Disease Control in Atopic Dermatitis Up to 3 Years

Monthly maintenance treatment with lebrikizumab-lbkz (Ebglyss; Lilly) led to sustained clear or almost clear skin for up to 3 years among adults and adolescents with moderate to sever atopic dermatitis (AD), according to data presented at the European Academy of Dermatology & Venereology Congress in Amsterdam, September 25-28.^1,2

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The findings, presented by Eli Lilly and Company, demonstrated that more than 80% of adult and adolescent participants in the company's phase 3 ADvocate 1 and 2 monotherapy trials who responded to lebrikizumab at 16 weeks of treatment and continued with therapy monthly for up to 3 years in the ADjoin extension study maintained Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) scores of 0 or 1.^1,2

"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," ADjoin senior author Eric Simpson, MD, MCR, professor of dermatology at Oregon Health & Science University School of Medicine, said in a statement.¹

Lebrikizumab is an injectable interleukin (IL)-13 inhibitor, formulated to selectively block IL-13 signaling with a high level of binding affinity. IL-13 is a key cytokine in the type-2 inflammatory cycle that drives the itch, skin barrier dysfunction, and skin thickening and infections that characterize AD. Lebrikizumab was approved for use in the US by the FDA on September 13, 2024.³

ADjoin after ADvocate

Study participants who had completed 52 weeks of lebrikizumab therapy in ADvocate 1 or 2 could opt to enroll in the ADjoin long-term extension study for another 100 weeks, which provided investigators with evidence of treatment outcomes based on 152 weeks of continuous lebrikizumab use. ADjoin participants recieved either 250 mg every 2 weeks or the same dose once monthly. The approved maintenance dosage of the drug 250 mg given every 4 weeks.¹

At the 3-year follow-up mark, the ADjoin investigators reported that:

• 84% of participants receiving lebrikizumab once monthly and 83% receiving the drug every 2 weeks maintained clear or almost clear skin (IGA 0,1)
• 87% of those dosed monthly and 79% dosed every 2 weeks achieved or maintained a 90% or greater improvement in severity and extent of disease, as assessed by the Eczema Area and Severity Index (EASI-90)
• 83% of the participants in the once-monthly dose subgroup and 91% in the every-2-week group did not require high-potency topical corticosteroids or systemic therapies over the 100-week extension.

The researchers reported no evidence of new safety concerns over the 3-year treatment period, stating that the lebrikizumab safety profile in ADjoin was consistent with earlier research. The adverse events (AEs) that were recorded were assessed as mild to moderate, and the most common were conjunctivitis, injection site reactions and herpes zoster. Less than 3% of participants experienced AEs that led to leaving the study.

"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,” Simpson concluded in the Lilly statement.

Lebrikizumab Background

Lebrikizumab may be used as monotherapy or in combination with topical corticosteroids. It is indicated for adults and children aged 12 years and older with moderate to severe AD, though patients must weigh 88 pounds (40 kg) at least and have not responded well to other topical options.

The safety and efficacy of this therapy among children who are under the age of 12 or among those aged 12 - 18 weighing under 88 pounds have not been established as of yet.

Additional data drawn from this clinical study is slated to be shared at upcoming conferences.

The lebrikizumab phase 3 trial program includes 5 key global studies evaluating more than 1300 participants. Two are monotherapy studies (ADvocate 1 and 2); another is a combination study with topical corticosteroids (ADhere). The long-term extension ADjoin study is complemented by the adolescent open label (ADore) study. Additional data from the latter 2 studies will be announced in later 2024 and early 2025.

References

1. New data show Lilly's EBGLYSS™ (lebrikizumab-lbkz) provided sustained disease control for up to three years in more than 80% of adults and adolescents with moderate-to-severe atopic dermatitis. Eli Lilly and Company. September 25, 2024. https://investor.lilly.com/news-releases/news-release-details/new-data-show-lillys-ebglysstm-lebrikizumab-lbkz-provided. Date accessed: September 25, 2024.
2. Thaci E, et al. Efficacy and safety of lebrikizumab is maintained up to three years in patients with moderate to severe atopic dermatitis: ADvocate 1, ADvocate 2, and ADjoin long-term extension trial. Presented at: the European Academy of Dermatology & Venereology Congress; September 25-28, 2024; Amsterdam, the Netherlands.
3. Halsey G. Lilly announces FDA approval of lebrikizumab-lbkz for moderate to severe atopic dermatitis. Patient Care. September 16, 2024. https://www.patientcareonline.com/view/lilly-announces-fda-approval-for-lebrikizumab-lbkz-of-moderate-to-severe-atopic-dermatitis