Lebrikizumab Demonstrates Efficacy in Itch and Skin Clearance Among Patients With AD Who Discontinued Dupilumab

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Lilly announced phase 3b ADapt study results at the 2024 Fall Clinical Dermatology Conference.¹ The data, presented in a poster,² reported efficacy of lebrikizumab (Ebglyss; Lilly) in patients with moderate to severe atopic dermatitis (AD) who had previously been treated with dupilumab (Dupixent; Sanofi and Regeneron).

The study was designed as a multicenter, open-label trial involving patients aged 12 years and older who had previously been treated with dupilumab. The primary objective was to assess the efficacy of lebrikizumab in improving skin symptoms and quality of life in this specific patient population.

Participants were required to have a confirmed diagnosis of moderate to severe AD and a history of inadequate response to dupilumab, which could include insufficient improvement in skin lesions or intolerable side effects. The study enrolled a total of 86 patients, who were administered lebrikizumab at a loading dose of 500 mg subcutaneously at baseline and again at week 2, followed by maintenance doses.

Researchers evaluated efficacy using several key metrics, including the Investigator's Global Assessment (IGA), the Eczema Area and Severity Index, and the Dermatology Life Quality Index (DLQI). The study specifically focused on the proportion of patients achieving significant improvements in these scores over a 24-week period.

The results indicated that a substantial percentage of patients experienced marked improvements in their skin condition and overall quality of life. 83% of patients with a baseline DLQI score of 4 or higher achieved at least a 4-point improvement by weeks 16 and 24.

Similarly, among those with a baseline pruritus numerical rating scale score of 4 or higher, 53% and 62% reported significant reductions in itch severity at weeks 16 and 24, respectively.

The safety of lebrikizumab was a critical component of the study. Adverse events (AEs) were closely monitored throughout the trial. The majority of reported AEs were mild to moderate in severity, with a small number leading to treatment discontinuation. The most common AEs included injection site reactions and mild infections, which are consistent with the safety profiles observed in other studies involving monoclonal antibodies for AD.

"Lebrikizumab provides meaningful improvements in skin (including face and hand) clearance, itch, and QoL in patient with moderate-to-severe AD who were previously treated with dupilumab," wrote poster authors Silverberg et al.

The study also assessed the reasons for discontinuation of dupilumab among participants. The primary reasons included inadequate response to treatment, intolerance, and other patient-reported factors.

"This trial supports the growing body of data showing that health care providers can have confidence prescribing Ebgylss as a first-line biologic treatment for moderate-to-severe atopic dermatitis, and reinforces that Ebgylss provided a meaningful benefit among individuals who have already tried another biologic treatment such as dupilumab and may have more difficult-to-treat disease," said Mark Genovese, MD, senior vice president of Lilly Immunology development, in a news release.¹

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References

1. Lilly's Ebglyss (lebrikizumab-lbkz) demonstrated meaningful improvement in skin clearance and itch relief in the majority of patients with moderate-to-severe atopic dermatitis who discontinued dupilumab. News release. Lilly. October 25, 2024. Accessed October 26, 2024. https://investor.lilly.com/news-releases/news-release-details/lillys-ebglysstm-lebrikizumab-lbkz-demonstrated-meaningful
2. Silverberg JI, Ackerman L, Rosmarin D, et al. Lebrikizumab in patients previously treated with dupilumab. Presented at: Fall Clinical 2024; October 24-27, 2024; Las Vegas, Nevada.