Lilly's IL-13 Inhibitor Lebrikizumab Combined with Topical Corticosteroids Achieves Phase 3 Clinical Endpoints in Moderate-to-Severe Atopic Dermatitis

Recently, Eli Lilly and Company announced that its investigational IL-13 inhibitor lebrikizumab, in combination with topical corticosteroids, met all primary and key secondary endpoints in a Phase 3 clinical trial for the treatment of patients with moderate to severe atopic dermatitis. Seventy percent of treated patients experienced at least a 75% improvement in disease severity (EASI-75). The lebrikizumab combination therapy also improved patients' itching, sleep quality, and quality of life.

Atopic dermatitis is a chronic inflammatory skin disease caused by skin barrier dysfunction and immune response imbalance. Patients typically experience intense and persistent itching, as well as dry skin and skin inflammation, which may affect sleep, daily activities, and social relationships. In patients with atopic dermatitis, the protein interleukin-13 (IL-13) is overexpressed, driving inflammation and leading to skin barrier dysfunction by promoting type 2 helper T cell (Th2) responses.

Lebrikizumab is an innovative monoclonal antibody drug that can bind to IL-13 with high affinity and high specificity, thereby preventing the formation of the IL-13Rα1/IL-4Rα complex and inhibiting the signaling pathway mediated by this receptor complex. Previously, lebrikizumab has been granted Fast Track designation by the U.S. FDA for the treatment of adult and adolescent patients with moderate to severe atopic dermatitis.

▲Lebrikizumab and Other Antibody Therapies Targeting the IL-4 and IL-13 Signaling Pathways: Mechanism of Action (Image Source: Reference [2])

In patients treated with lebrikizumab plus topical corticosteroids, 41% achieved clear or almost clear skin at 16 weeks, compared to 22% in the placebo plus topical corticosteroid group. At 16 weeks, 70% of patients in the lebrikizumab plus topical corticosteroid group reached EASI-75, versus 42% in the control group. The difference in EASI-75 between the two groups began to show after 4 weeks of treatment.

"Today's clinical trial data, together with the results from the previous monotherapy study in the ADvocate clinical trial, demonstrate that lebrikizumab, whether used alone or in combination with topical medications, may reduce disease burden and provide relief for patients with uncontrolled atopic dermatitis," said Dr. Eric Simpson, Professor of Dermatology at Oregon Health & Science University in Portland and principal investigator of this clinical study. "Lebrikizumab specifically targets the IL-13 pathway, which plays a central role in this chronic inflammatory disease. These results enhance our understanding of lebrikizumab in treating atopic dermatitis and help establish it as a potential new treatment option."

References:

[1] Lilly's Lebrikizumab Combined with Topical Corticosteroids Showed Significant Improvements in Disease Severity for Atopic Dermatitis. Retrieved April 13, 2022, from https://investor.lilly.com/news-releases/news-release-details/lillys-lebrikizumab-combined-topical-corticosteroids-showed

[2] Moyle et al., (2019). Understanding the immune landscape in atopic dermatitis: The era of biologics and emerging therapeutic approaches. Experimental Dermatology, https://doi.org/10.1111/exd.13911

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