Lebrikizumab Leads to Sustained Disease Control for Atopic Dermatitis Up to 3 Years

Eric Simpson, MD, MCR/ Credit: OHSU

Lebrikizumab-lbkz (Ebglyss) treatment of moderate to severe atopic dermatitis may lead to sustained disease control among adults and adolescents for up to 3 years, according to recent data presented at the European Academy of Dermatology & Venereology Congress in Amsterdam.^1,2

The data demonstrated that over 80% of adults and adolescent patients responding at the 16-week mark to lebrikizumab in the ADvocate 1 and 2 monotherapy studies and carried on with the medication with monthly maintenance dosing for up to 3 years had sustained skin clearance. These findings were presented by Eli Lilly and Company.

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

Lebrikizumab is an injectable drug and an interleukin (IL)-13 inhibitor, formulated to block IL-13 signaling with a high level of binding affinity. It targets IL-13 as it drives type-2 inflammation, contributing to itch, skin barrier dysfunction, infections, thickened skin that characterize atopic dermatitis.

ADvocate and ADjoin Design

Individuals who finished up the 52 weeks of lebrikizumab therapy in ADvocate 1 or 2 were permitted to take part in the ADjoin extension study for another 100 weeks, providing the investigators evidence on 152 weeks of continuous lebrikizumab use. The drug was either given to patients at a dose of 250 mg on an every-2-week basis or once-per-month, and the approved maintenance dose was 250 mg every 4 weeks.

The findings presented also include individuals who had been included in ADvocate 1 and ADvocate 2 and responded to therapy by the 16-week mark.

Major Findings

The study’s investigators concluded that 84% of those on the once-per-month dosing regimen and 83% of those on the bi-weekly regimen were successful in maintaining clear or almost-clear skin (Investigator Global Assessment 0 or 1) following the 3-year course of therapy.

The research team also concluded that 87% of subjects on the once-per-month dose as well as 79% of those on the bi-weekly dose were able to successfully achieve or maintain 90% or greater improvement in their disease severity as indicated by Eczema Area and Severity Index (EASI-90) over the same timeframe.

Additionally, the research team noted that 83% of individuals on the monthly dosing regimen and 91% of those on the bi-weekly one did not require any high-potency topical corticosteroids or systemic therapies.

Given the lack of safety issues seen by the investigators up to 3 years of therapy, the team reported that the drug’s safety profile in ADjoin was consistent with earlier research. Most adverse events they identified were noted as mild to moderate, and less than 3% quit the treatment given any side effects.

"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 his statement.

Additional Notes on Lebrikizumab

The drug may be implemented with or without topical corticosteroids. It is for adults and children aged 12 years and up with moderate to severe atopic dermatitis, 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 medication was recently given US Food and Drug Administration (FDA) approval and was approved in the European Union and Japan.

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 held September 25-28, 2024, in Amsterdam.}