Lilly's Lebrikizumab Achieves Phase 3 Trial Endpoints with Over 50% of Patients Showing ≥75% Skin Symptom Improvement in Moderate-to-Severe Atopic Dermatitis

On August 16, 2021, Eli Lilly and Company announced that lebrikizumab, an IL-13-targeting monoclonal antibody therapy, met the primary endpoint and all key secondary endpoints in two pivotal Phase 3 clinical trials, ADvocate 1 and ADvocate 2. Trial results demonstrated that, compared with placebo, lebrikizumab enabled more than half of patients with moderate-to-severe atopic dermatitis (AD) to achieve at least a 75% improvement in skin symptoms (EASI 75). Additionally, patients experienced significant improvements in pruritus, itch-related sleep interference, and quality of life. The safety profile was consistent with previous studies. Complete trial results will be presented at a future conference in 2022.

Atopic dermatitis, also known as eczema, is a chronic inflammatory skin disease caused by skin barrier dysfunction and immune dysregulation. Patients typically experience intense, persistent pruritus, along with dry skin and cutaneous inflammation, which may impair sleep, daily activities, and social relationships. In patients with atopic dermatitis, interleukin-13 (IL-13) is overexpressed and drives inflammation and skin barrier dysfunction by promoting type 2 helper T cell (Th2) responses.

Lebrikizumab is an innovative monoclonal antibody that binds to IL-13 with high affinity and high specificity, thereby preventing the formation of the IL-13Rα1/IL-4Rα receptor complex and inhibiting the signaling pathway mediated by this complex. Previously, lebrikizumab was granted Fast Track designation by the U.S. FDA for the treatment of adult and adolescent patients with moderate-to-severe atopic dermatitis, and has demonstrated positive results in Phase 2b clinical trials.

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

Regarding safety, during the initial 16-week controlled period, the incidence of treatment-emergent adverse events (AEs) and serious AEs with lebrikizumab treatment was consistent with previous studies. The most common AEs included conjunctivitis, nasopharyngitis, and headache. The incidence of discontinuation due to AEs in the lebrikizumab group (1.4%) was similar to that in the placebo group (1.7%).

References:

[1] Lilly's lebrikizumab significantly improved skin clearance and itch in people with moderate-to-severe atopic dermatitis in two Phase 3 trials. Retrieved August 16, 2021, from https://investor.lilly.com/news-releases/news-release-details/lillys-lebrikizumab-significantly-improved-skin-clearance-and

[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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