Lebrikizumab Demonstrates Durable Efficacy in Atopic Dermatitis with 80% of Patients Maintaining Skin Clearance at One Year

Today, Eli Lilly and Company announced that its investigational IL-13 inhibitor lebrikizumab demonstrated long-term efficacy in a Phase 3 clinical trial for patients with moderate to severe atopic dermatitis. Among patients who achieved clinical remission after 16 weeks of lebrikizumab monotherapy, 80% maintained clear skin symptoms at 52 weeks (with maintenance treatment every two or four weeks). Additionally, patients maintained itch relief over the course of one year.

Atopic Dermatitis, Also Known as Eczema, Is a Chronic Type 2 Inflammatory Skin Disease: 85-90% of Patients Develop Symptoms Before the Age of 5, and the Condition Often Persists Into Adulthood. Symptoms Include Intense, Persistent Itching and Skin Lesions Covering Most Parts of the Body, Leading to Dry, Cracked, Painful, Red or Darkened, Crusted, and Bleeding Skin, Along With an Increased Risk of Skin Infections.

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 phase 3 clinical trial named ADvocate 1, 79% of patients treated every four weeks and 79% of patients treated every two weeks maintained more than 75% improvement in skin symptoms (EASI-75) after one year. In the phase 3 clinical trial named ADvocate 2, 85% of patients treated every four weeks and 77% of patients treated every two weeks sustained EASI-75 relief.

Based on these data, Eli Lilly plans to submit the Biologics License Application (BLA) for lebrikizumab in the second half of this year.

"Atopic dermatitis is a complex disease that requires personalized treatment plans, including flexible dosing options. In these studies, patients treated with lebrikizumab maintained clear skin and itch relief at one year. We believe this supports the potential of lebrikizumab as a first-line biologic therapy and enables less frequent dosing regimens," said Dr. Lotus Mallbris, Vice President of Global Immunology Development and Medical Affairs at Eli Lilly and Company.

References:

[1] Eight out of Ten Patients Maintained Skin Clearance at One Year in Lilly's Lebrikizumab Atopic Dermatitis Monotherapy Trials. Retrieved June 7, 2022, from https://investor.lilly.com/news-releases/news-release-details/eight-out-ten-patients-maintained-skin-clearance-one-year-lillys

[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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