Trial Shows Lilly’s Lebrikizumab Produces Improvements in Atopic Dermatitis Severity, Particularly in Individuals with Skin of Color

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New trial data show that 68% of participants with skin of color suffering from moderate-to-severe atopic dermatitis who were administered Eli Lilly’s lebrikizumab experienced at least a 75% reduction in disease severity, including skin clearance and itch relief. The study notes that people with skin of color have faced a lack of representation in previous clinical trials and are more likely to experience severe symptoms of atopic dermatitis and face delays in diagnosis and treatment.¹

"People with skin of color are disproportionately affected by atopic dermatitis, often experiencing more severe symptoms, a delay in diagnosis and a lengthier timeframe to find appropriate treatment. They also have been historically underrepresented in clinical trials, which means we have lacked data pertaining to the treatment of patients with skin of color," said lead study investigator Andrew Alexis, MD, MPH, professor of clinical dermatology, vice chair for diversity and inclusion, department of dermatology, Weill Cornell Medicine, dermatologist, New York-Presbyterian/Weill Cornell Medical Center, in a press release. "With these initial results, Lilly is taking a step toward investigating the needs of people with skin of color affected by atopic dermatitis."

The study, which ran for 16 weeks and included 50 patients with moderate-to-severe atopic dermatitis and darker skin tones, included Black or African American individuals at 80%, Asian individuals at 14%, and American Indian or Alaska Natives at 6%. Additionally, 11 of the patients identified as Hispanic/Latinx.

Additional results of the trial found:

• 46% experienced a 90% or higher improvement in disease extent and severity.
• 39% achieved clear or nearly clear skin.
• 55% reported clinically meaningful itch relief.¹

Back in October, Lilly also published more generalized results from the use of lebrikizumab in patients with moderate-to-severe atopic dermatitis for up to two years. These results indicated that close to 80% of participants sustained clear or close to clear skin stemming from the treatment. During the ADjoin clinical trial, 62% of participants reported a combination of mild to severe adverse events (AEs), with the most common AEs being conjunctivitis, injection site reactions, and shingles (herpes zoster).²

"Results from ADjoin reinforce the strong efficacy and safety profile of lebrikizumab seen in the other Phase III atopic dermatitis trials. These data also further our understanding of the long-lasting benefits of lebrikizumab as a potential first-line biologic treatment for patients," said Lotus Mallbris, MD, PhD, SVP, global immunology development and medical affairs, Lilly, in a press release. "We look forward to working with global regulatory authorities to bring this important medicine to patients."

The first of its kind study found no new serious AEs. It also included use of Lilly’s new PDCA-Derm scale to assess changes in post-inflammatory pigmentation.¹

"Lebrikizumab is the first investigative treatment for atopic dermatitis to disclose robust efficacy data specifically for people with skin of color, who may experience barriers to treatment or inequitable care," said Mark Genovese, MD, SVP, immunology development, Lilly, in the release. "Through clinical trials like this, we hope to deliver more breakthroughs to make life better for people who have been underserved."¹

References

1. More than two-thirds of people with atopic dermatitis and skin of color experienced skin improvement in a first-of-its-kind lebrikizumab study. Lilly. March 10, 2024. Accessed March 11, 2024. https://investor.lilly.com/news-releases/news-release-details/more-two-thirds-people-atopic-dermatitis-and-skin-color

2. Nearly 80% of patients with moderate-to-severe atopic dermatitis maintained clear or almost clear skin with Lilly's lebrikizumab monthly maintenance dosing at two years. Lilly. October 20, 2023. Accessed March 10, 2024. https://investor.lilly.com/news-releases/news-release-details/nearly-80-patients-moderate-severe-atopic-dermatitis-maintained