Ebglyss Shows Significant Improvement in Skin Symptoms, Itch for Moderate-to-Severe Atopic Dermatitis

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Ebglyss (lebrikizumab-lbkz) was found to significantly improve skin symptoms and decrease itching in patients with moderate-to-severe atopic dermatitis (AD), according to findings from the ADapt Phase IIIb trial (NCT05369403). These findings, which included patients who previously discontinued treatment with Dupixent (dupilumab), bolster the use of Ebglyss as an effective option for AD in difficult-to-treat areas, such as the hands and face, according to trial investigators.¹

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

Ebglyss, an interleukin-13 (IL-13) inhibitor, selectively stops IL-13 signaling with high binding affinity, which drives the type 2 inflammatory cycle in the skin, causing skin barrier dysfunction, itch, and thickening and infection of the skin. Ebglyss was approved by the FDA last month for the treatment of moderate-to-severe AD in adults and children 12 years of age and older weighing at least 88 lbs.²

The approval was based on data from the ADvocate 1, ADvocate 2, and ADhere clinical trials.² The ADvocate trials show that 38% of patients administered Ebglyss achieved clear or almost-clear skin at 16 weeks, compared to 12% of patients receiving placebo. Further, 77% of patients who responded to treatment maintained the response for up to one year with monthly dosing. Additionally, 43% of patients experienced significant itch relief by week 16 compared to 12% on placebo, and 85% maintained this relief for one year of treatment.

The open-label, 24-week ADapt trial analyzed the efficacy and safety of Ebglyss in adults and adolescents aged 12 to less than 18 years and weighing ≥40 kg with moderate-to-severe AD who discontinued prior treatment with Dupixent. The trial’s primary endpoint was at least a 75% improvement in the Eczema Area and Severity Index (EASI-75) score at 16 weeks.

Patients were administered Ebglyss four or more weeks after discontinuing Dupixent, receiving a starting dosing of 500 mg via two 250 mg injections at weeks zero and two, followed by 250 mg every two weeks until week 16. Those with Investigator Global Assessment (IGA) scores of clear (0) or almost clear (1) skin or an EASI-75 score at week 16 were administered 250 mg once monthly, whereas non-responders stayed on the 250 mg every two weeks regimen until week 24.

Results showed that 57% of patients administered Ebglyss achieved EASI-75 at week 16, and 60% of patients who received prior treatment with Dupixent achieved EASI-75 at week 24. These findings were similar to results from the ADvocate 1 and ADvocate 2 trials.

Further, 46% of those who did not achieve an adequate response to Dupixent achieved an EASI-75 response with Ebglyss at week 16. A total of 53% percent and 62% of patients enrolled in ADapt who discontinued Dupixent and initiated treatment with Ebglyss experienced at least a four-point improvement in itch relief from baseline at weeks 16 and 24, respectively.

In terms of difficult-to-treat areas of the skin, 52% of those administered Ebglyss experienced clear or almost clear face dermatitis at week 24 (F-IGA 0,1) showing a decrease of at least two points from baseline. Patients with moderate-to-severe hand dermatitis at baseline experienced a 75% reduction in modified total lesion symptom score at week 24.

The safety of Ebglyss in the trial was consistent with findings from prior Phase III trials of the drug in patients with moderate-to-severe AD, with no new safety signals reported. Common adverse events associated with Ebglyss include eye and eyelid inflammation, such as redness, swelling, and itching; injection site reactions; and shingles.²

"Treatment isn't one-size-fits-all, and many patients with moderate-to-severe atopic dermatitis remain in need of an effective medicine to help manage the impact of the disease, especially in difficult-to-treat areas like face and hands," ADapt investigator Linda Stein Gold, MD, director of dermatology research and head of the Division of Dermatology for Henry Ford Health System in Detroit, Michigan, said in the release. "These data showed that Ebglyss improved skin symptoms and reduced itch for the majority of patients who had stopped using dupilumab and complement previously presented Ebglyss data in biologic-naive patients, further supporting that a broad range of patients could benefit from this new and effective treatment option."¹

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. Eli Lilly. October 25, 2024. Accessed October 25, 2024. https://investor.lilly.com/news-releases/news-release-details/lillys-ebglysstm-lebrikizumab-lbkz-demonstrated-meaningful

2. FDA Approves Lilly's EBGLYSS™ (lebrikizumab-lbkz) for Adults and Children 12 Years and Older with Moderate-to-Severe Atopic Dermatitis. Lilly. September 13, 2024. Accessed October 25, 2024. https://investor.lilly.com/news-releases/news-release-details/fda-approves-lillys-ebglysstm-lebrikizumab-lbkz-adults-and