Clinical Trial Results Show Lilly’s Lebrikizumab Improves Severity of Atopic Dermatitis

Approximately 70% of individuals with moderate-to-severe atopic dermatitis (AD) receiving lebrikizumab combined with standard-of-care topical corticosteroids (TCS) achieved at least a 75% improvement in overall disease severity in the ADhere trial at 16 weeks, Eli Lilly and Company said at the 4th Annual Revolutionizing Atopic Dermatitis (RAD) Conferences.

Lebrikizumab is an investigational interleukin-13 (IL-13) inhibitor that showed improvements in itch, quality of life, and sleep interference, when combined with TCS compared with the placebo and TCS.

“[Adhere’s] data, together with results from the ADvocate monotherapy studies, demonstrate the potential for lebrikizumab to reduce disease burden and provide relief for people with uncontrolled atopic dermatitis when used either alone or combined with topicals,” Eric Simpson, MD, MCR, professor of dermatology and director of clinical research at Oregon Health and Science University in Portland, said in a statement.

“Lebrikizumab specifically targets the IL-13 pathway, which plays the central role in this chronic inflammatory disease. These results strengthen our understanding of lebrikizumab in atopic dermatitis and help establish it as a possible new treatment option,” Simpson said.

IL-13 plays a central role in type 2 inflammation in AD and underlies the signs and symptoms, including hardened thickened areas of skin, infection, itch, and skin barrier dysfunction.

Among individuals taking lebrikizumab with TCS, approximately 41% achieved clear or almost clear skin at 16 weeks compared with 22% of individuals taking the placebo and TCS.

Additionally at week 16, approximately 70% of individuals taking lebrikizumab and TCS achieved an Eczema Area and Severity Index of a 75% (EASI-75) reduction response compared with 42% for the placebo and TCS.

The differences between the individuals on both combinations were observed as early as 4 weeks for EASI-75.

Individuals treated with lebrikizumab plus TCS also achieved statistically significant improvements across key secondary endpoints, including itching, interference of itching on sleep, quality-of-life measures, and skin clearance compared with the placebo and TCS.

Clinically meaningful differences were observed as early as 4 weeks for itching, interference of itching on sleep, and quality-of-life measures.

Investigators noted that the safety results were consistent with prior lebrikizumab studies in AD. Individuals who took lebrikizumab and TCS reported a higher frequency of adverse events (AEs) compared with those taking the placebo and TCS. Most AEs were mild or moderate in severity. The AEs did not lead to the discontinuation of lebrikizumab.

The most common AEs for those on lebrikizumab were conjunctivitis and headaches.

Lilly also recently announced 16-week data from the ongoing ADvocate studies, and an encore presentation of results were presented at RAD 2022. Long-term data from the ADvocate studies will be disclosed in the upcoming months.

Lebrikizumab is a novel, monoclonal antibody that binds to the IL-13 protein with high affinity to specifically prevent the formation of IL-13Rα1/IL-4Rα, which blocks the downstream signaling through the IL-13 pathway.

Reference

Lilly’s lebrikizumab combined with topical corticosteroids showed significant improvements in disease severity for atopic dermatitis. Lilly. News release. April 11, 2022. Accessed April 12, 2022. https://investor.lilly.com/news-releases/news-release-details/lillys-lebrikizumab-combined-topical-corticosteroids-showed