Lebrikizumab FDA Approved for Moderate to Severe Atopic Dermatitis in Adults and Children

The US Food and Drug Administration (FDA) has approved Eli Lilly’s EBGLYSS (lebrikizumab-lbkz), an IL-13 inhibitor, for the treatment of moderate to severe atopic dermatitis in adults and children aged 12 years and older, weighing at least 88 lbs. This biologic treatment is designed for individuals whose eczema is not adequately controlled by topical prescription therapies. Lebrikizumab provides a novel option, targeting the underlying inflammation responsible for eczema symptoms like itchiness and dry and irritated skin.

Lebrikizumab is administered as an injection, with an initial dose of 500 mg followed by biweekly doses of 250 mg until week 16, transitioning to a monthly maintenance dose of 250 mg. It can be used with or without topical corticosteroids. The drug’s approval was based on results from clinical trials (ADvocate 1, ADvocate 2, and ADhere) involving over 1000 participants, including both adults and children. The studies showed that lebrikizumab significantly improved skin clearance and itch relief, with 38% of patients achieving clear or almost-clear skin after 16 weeks compared to 12% on placebo. Many patients experienced significant itch relief as early as 2 weeks, and these results were sustained through 1 year of treatment.

The ADvocate 1 and 2 studies evaluated lebrikizumab as monotherapy, while the ADhere study assessed its use in combination with topical corticosteroids. In these studies, 43% of patients reported itch relief at week 16 compared to 12% on placebo. Of those who achieved clear or almost-clear skin at week 16, 77% maintained these results after 1 year of treatment. Additionally, patients who experienced itch relief sustained that benefit, with 85% still reporting relief after 1 year of monthly maintenance doses.

The safety profile of lebrikizumab was consistent with known risks of biologic therapies, with common side effects including injection site reactions and eye inflammation (such as redness, swelling, and itching). Some patients also reported shingles (herpes zoster). Importantly, the studies indicated no new safety signals over the 1-year period.

The FDA approval of lebrikizumab offers a new first-line biologic treatment for those who have not found relief with topical therapies. Clinical data demonstrated that lebrikizumab not only improved skin condition but also provided meaningful and sustained itch relief, a significant factor in improving patients' overall well-being.

Lebrikizumab represents a significant advancement in the treatment of moderate to severe atopic dermatitis. By targeting IL-13, a key cytokine involved in eczema inflammation, it provides a targeted approach to disease management. Its ability to deliver rapid, significant, and sustained relief makes it a promising option for patients seeking long-term control of their eczema symptoms. The drug’s approval marks a pivotal step in addressing an unmet need for effective and durable treatments for moderate to severe eczema.

Reference
FDA approves Lilly's EBGLYSS (lebrikizumab-lbkz) for adults and children 12 years and older with moderate-to-severe atopic dermatitis. Press Release. Eli Lilly and Company. September 13, 2024. Accessed September 16, 2024. https://investor.lilly.com/news-releases/news-release-details/fda-approves-lillys-ebglysstm-lebrikizumab-lbkz-adults-and