More than two-thirds of people with atopic dermatitis (AD) and darker skin tones treated with lebrikizumab showed improvements in skin clearance and itch relief, according to late-breaking results from a Phase 3 study are being presented at the 2024 American Academy of Dermatology (AAD) Annual Meeting in San Diego.
Lebrikizumab (Ebglyss, Almirall), an interleukin-13 (IL-13) inhibitor, just received European Commission approval this year, and it is making its way down the pike in the US too. 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 as measured by the Fitzpatrick scale, 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%). All patients received lebrikizumab 500mg subcutaneously initially and at two weeks followed by 250mg subcutaneously every two weeks to Week 16. Results at 16 weeks were consistent with the 16-week results from the ADhere and ADvocate 1 & 2 studies.
Specifically:
- 68% of people experienced significant improvement of at least 75% in the Eczema Area and Severity Index (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 (Investigator Global Assessment 0,1) with a reduction of at least two points from baseline.
- 55% of people experienced clinically meaningful itch relief ( Peak Pruritus Numerical Rating Scale ≥4-point improvement)§.
No new safety signals were observed and there were no serious adverse events reported.
The study also included a physician assessment of changes in post-inflammatory pigmentation using the newly developed PDCA-Derm scale.
“With these initial results, Lilly is taking a step toward investigating the needs of people with skin of color affected by atopic dermatitis,” says study author 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, in a news release.
Lilly plans to share full efficacy and safety results from the study at future congresses.
