Lilly Reports Positive Phase 3 Results for Lebrikizumab in Moderate-to-Severe Atopic Dermatitis with Over Half of Patients Achieving ≥75% Improvement

Recently, Eli Lilly and Company announced positive results from a pivotal phase 3 clinical trial of its investigational IL-13 inhibitor lebrikizumab as a monotherapy for the treatment of patients with moderate-to-severe atopic dermatitis. After 16 weeks of treatment, over 50% of patients experienced at least a 75% reduction in disease severity (EASI-75). Moreover, lebrikizumab also provided clinically meaningful improvements in itching and other important patient-reported outcomes.

Atopic Dermatitis: A Chronic Inflammatory Skin DiseaseAtopic dermatitis is a chronic inflammatory skin disease caused by skin barrier dysfunction and immune response imbalance. Patients typically experience intense and persistent itching, along with symptoms such 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.

▲Mechanism of action of Lebrikizumab and other antibody therapies targeting the IL-4 and IL-13 signaling pathways (Image source: Reference [2])

In the study named ADvocate 1, 43% of patients receiving lebrikizumab achieved clear or almost clear skin standards (IGA) at 16 weeks, compared to 13% of patients receiving placebo. Among those treated with lebrikizumab, 59% achieved an EASI-75 response, versus 16% in the placebo group.

In the ADvocate 2 study, 33% of patients taking lebrikizumab achieved clear or almost clear skin at 16 weeks, compared to 11% in the placebo group. Among patients receiving lebrikizumab, 51% achieved an EASI-75 response, compared to 18% in the placebo group.

Lotus Mallbris, M.D., Ph.D., Vice President of Global Immunology and Medical Affairs at Eli Lilly and Company, said: "The experiences of patients battling autoimmune diseases drive us at Lilly to pursue innovative science and meaningful treatments to improve their lives, particularly in areas of urgent unmet need. These data further validate the positive results from our broader Phase 3 development program, and we believe lebrikizumab represents a new generation of biologics for the treatment of atopic dermatitis."

References:

[1] Majority of Patients Treated with Lebrikizumab Achieved Skin Clearance in Lilly's Pivotal Phase 3 Atopic Dermatitis Studies. Retrieved March 28, 2022, from https://investor.lilly.com/news-releases/news-release-details/majority-patients-treated-lebrikizumab-achieved-skin-clearance

[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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