Study Reports Long-Term Efficacy of Lebrikizumab for AD

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Today, Lilly announced promising long-term results from the ADjoin (NCT04392154)study, demonstrating the efficacy of lebrikizumab (Ebglyss; Lilly) for moderate to severe atopic dermatitis (AD). According to a news release, the study found that over 80% of patients who responded to lebrikizumab treatment at week 16 in the ADvocate 1 and 2 trials maintained clear or almost-clear skin after 3 years of continued treatment. Findings from the study were presented at the European Academy of Dermatology and Venereology (EADV) Congress taking place this week in Amsterdam, Netherlands.¹

Lebrikizumab is an interleukin-13 (IL-13) inhibitor recently approved by the US FDA for moderate to severe AD.² It was also approved in the European Union in 2023, as well as in Japan in January 2024. According to the release, it is expected to be approved in additional markets later this year.

"The chronic and persistent signs and symptoms of AD affect patients' daily lives, highlighting the need for a treatment that can provide sustained, long-term relief," Eric Simpson, MD, MCR, professor of dermatology and director of clinical research at Oregon Health and Science University School of Medicine in Portland, Oregon, and senior author and investigator of the ADjoin analysis, said in the release. "These 3-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."

Participants who completed 52 weeks of the ADvocate trials were eligible to enroll in the ADjoin extension study, which allowed for an additional100 weeks of treatment (up to 152 weeks of continuous treatment). In this long-term analysis, participants received lebrikizumab at a dose of 250 mg either every 2 weeks (Q2W) or once monthly (Q4W). According to the news release, the approved maintenance dosage is 250 mg Q4W.

The results of the extension study included:

• Skin Clearance: 84% of patients taking lebrikizumab monthly and 83% taking it biweekly maintained clear or almost-clear skin after 3 years.
• Disease Improvement: 87% of patients on the monthly regimen and 79% on the biweekly regimen achieved or maintained at least a 90% improvement in disease extent and severity.
• Reduced Need for Additional Treatments: 83% of patients on the monthly regimen and 91% on the biweekly regimen did not require high-potency topical corticosteroids or systemic treatments during the study period.

The study found that the safety profile of lebrikizumab remained consistent with prior studies, with most adverse events reported as mild or moderate. Researchers stated less than 3% of patients experience adverse events that led to discontinuation of treatment. The most common adverse events were conjunctivitis, injection site reaction, and shingles.

"Without adequate treatment, AD can leave people struggling with uncontrolled symptoms," said Mark Genovese, MD, senior vice president of Immunology Development at Lilly, in the release. "EBGLYSS selectively targets IL-13, 1 of the main drivers of inflammation in eczema. These 3-year data demonstrate that EBGLYSS given once monthly provides durable symptom relief for patients who need it most."

Additional data from the study is underway, according to the release, with further results to be presented at future congresses.

"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, MD, chief medical officer at Almirall, in the release. "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."

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. News Release. PR Newswire. September 25, 2024. Accessed September 25, 2024. https://www.prnewswire.com/news-releases/new-data-show-lillys-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-302257401.html
2. FDA approves Lilly's Ebglyss (lebrikizumab-lbkz) for adults and children 12 years and older with moderate-to-severe atopic dermatitis. News release. Lilly. September 13, 2024. Accessed September 25, 2024. https://investor.lilly.com/news-releases/news-release-details/fda-approves-lillys-ebglysstm-lebrikizumab-lbkz-adults-and#:~:text=INDIANAPOLIS%20%2C%20Sept.%2013%2C%202024,88%20pounds%20(40%20kg)%20with