Phase III results presented during a late-breaking session at the annual meeting of the American Academy of Dermatology in San Diego, Calif. indicate that more than two-thirds of people with skin of colour and atopic dermatitis showed improvement in skin clearance and itch relief when treated with lebrikizumab.
Lebrikizumab is an anti-interleukin-13 monoclonal antibody. Pharmaceutical company Eli Lilly has exclusive rights for the development and commercialization of lebrikizumab in the U.S. and the rest of the world outside Europe.
The initial 16-week data from this study evaluated 50 patients with moderate-to-severe atopic dermatitis and darker skin tones, including people who self-identify as Black or African American (80%), Asian (14%), American Indian or Alaska Native (6%). Of the 50 patients, 11 also self-identified as Hispanic/Latinx (22%) with the remaining 39 self-identifying as non-Hispanic/Latinx (78%). Initial doses of lebrikizumab 500 mg subcutaneously and at two weeks were followed by 250 mg subcutaneously every two weeks through to Week 16.
All patients had chronic AD for at least one year, moderate to severe disease at baseline, a history of an inadequate response to topical therapies, and were naive to biologics indicated for AD.
The results showed that:
68% of people experienced significant improvement of at least 75% in disease extent and severity (EASI-75);
46% of people experienced at least 90% improvement in disease extent and severity (EASI-90);
39% of people achieved clear or almost clear skin (IGA 0,1) with a reduction of at least two points from baseline; and
56% of people experienced clinically meaningful itch relief (PNRS ≥4-point improvement).
“People with skin of colour 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 colour,” said Andrew Alexis, MD, MPH, Professor of Clinical Dermatology and Vice Chair for Diversity and Inclusion in the Department of Dermatology at Weill Cornell Medicine, a dermatologist at New York-Presbyterian/Weill Cornell Medical Center, and lead study investigator in a release.
“Lebrikizumab is the first investigative treatment for atopic dermatitis to disclose robust efficacy data specifically for people with skin of colour, who may experience barriers to treatment or inequitable care,” said Dr. Mark Genovese, senior vice president of Immunology Development at Eli Lilly. “Through clinical trials like this, we hope to deliver more breakthroughs to make life better for people who have been underserved.”
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