Lilly's lebrikizumab, delayed at FDA, clears eczema in people with skin of color

Eli Lilly’s eczema medicine lebrikizumab cleared skin and provided itch relief in a study that was specifically designed for people with skin of color.

The phase 3 results, presented at the American Academy of Dermatology Annual Meeting over the weekend, matched previous data from a previous late-stage study of the IL-13-targeting monoclonal antibody, Lilly said in a Sunday press release. The company evaluated 50 patients with moderate to severe atopic dermatitis and darker skin tones in the ADmirable trial over 16 weeks. The trial makeup included 80% people who self-identify as Black or African American, 14% as Asian and 6% as American Indian or Alaska Native. Of the 50 patients, 11 also self-identified as Hispanic/Latinx.

Lebrikizumab spurred significant improvement of at least 75% in disease extent and severity in 68% of people; 46% of people had 90% improvement; 39% achieved clear or almost clear skin and 56% experienced clinically meaningful itch relief.

No new safety signals were discovered in the trial, and there were no serious adverse events. More detailed results will be shared at a future medical meeting.

"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, M.D., senior vice president of immunology development at Lilly. "Through clinical trials like this, we hope to deliver more breakthroughs to make life better for people who have been underserved."

Atopic dermatitis, commonly called eczema, is more common and can be more severe in people of color, according to the study’s lead investigator.

"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 Andrew Alexis, M.D., professor of clinical dermatology and vice chair for diversity and inclusion in the Department of Dermatology at Weill Cornell Medicine and a dermatologist at New York-Presbyterian/Weill Cornell Medical Center.

The results provide more weight to Lilly’s argument that lebrikizumab is ready for the market. The FDA rejected an application for atopic dermatitis in October 2023, citing issues at a third-party contract manufacturing site. That application was based on the ADhere and ADvocate 1 and 2 studies.

Lilly licensed lebrikizumab in the U.S. and the rest of the world outside of Europe from Almirall S.A., which retained rights within Europe. Almirall managed to get approval from the European Commission in November 2023, clearing the way to treat patients 12 and older with moderate to severe atopic dermatitis in that region.