Lilly's Lebrikizumab Demonstrates Sustained Efficacy in Moderate-to-Severe Atopic Dermatitis with 80% of Patients Maintaining Clear or Almost Clear Skin at Two Years

▎WuXi

Edited by Kant Content Team

Recently, Eli Lilly and Company announced the long-term efficacy of its investigational IL-13 inhibitor lebrikizumab in patients with moderate to severe atopic dermatitis. The results showed that,Patients with moderate-to-severe atopic dermatitis maintained clinical benefits, including skin clearance, itch relief, and reduced disease severity, through monthly maintenance use of lebrikizumab over a two-year extension trial.

Atopic dermatitis, also known as eczema, is a chronic type 2 inflammatory skin disease. Symptoms appear in 85-90% of patients before the age of 5 and often persist into adulthood. Symptoms include intense and persistent itching, skin lesions covering most parts of the body, leading to dry, cracked, painful, red or darkened, crusted, and bleeding skin, as well as 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 inhibit the signaling pathway mediated by this receptor complex. Previously, lebrikizumab received Fast Track designation from the U.S. FDA for the treatment of adult and adolescent patients with moderate to severe atopic dermatitis.

Image Source: 123RF

ADjoin is a two-year extension trial, with patients coming from the lebrikizumab monotherapy trials ADvocate 1 and ADvocate 2, as well as the lebrikizumab combined with topical corticosteroids trial Adhere. Patients who achieved an Investigator's Global Assessment (IGA) response score of 0 (clear) or 1 (almost clear), or a 75% reduction in Eczema Area and Severity Index (EASI-75) relative to baseline after 16 weeks of lebrikizumab treatment, are eligible for inclusion in the ADjoin trial. Participants in the long-term extension trial will receive 250 mg of lebrikizumab every two weeks or monthly.

In the ADjoin trial,Monthly or biweekly administration of lebrikizumab for two years provides sustained efficacy for patients' skin symptoms and itching.

▲ Efficacy Results of Patients Entering the Long-Term Extension Study Adjoin (Image Source: Reference [1])

In the ADjoin study, the safety of lebrikizumab was consistent with the results reported in previous studies involving patients with moderate to severe atopic dermatitis, with no new safety signals observed during up to two years of treatment. In the ADjoin study, 62% of patients reported adverse events, most of which were mild or moderate. The most common side effects were conjunctivitis, injection site reactions, and herpes zoster. Less than 3% of patients discontinued treatment due to adverse events.

[1] Nearly 80% of patients with moderate-to-severe atopic dermatitis maintained clear or almost clear skin with Lilly's lebrikizumab monthly maintenance dosing at two years. Retrieved October 23, 2023, from https://www.prnewswire.com/news-releases/nearly-80-of-patients-with-moderate-to-severe-atopic-dermatitis-maintained-clear-or-almost-clear-skin-with-lillys-lebrikizumab-monthly-maintenance-dosing-at-two-years-301962678.html