Watch as Dr James Q Del Rosso provides a comprehensive overview of lebrikizumab’s clinical trial results, efficacy, safety, dosing, and more. 

Eli Lilly’s EBGLYSS (lebrikizumab-lbkz) has been approved by the FDA for adults and children aged 12 and older with moderate-to-severe atopic dermatitis that is inadequately controlled with topical therapies. 

EBGLYSS, a targeted IL-13 inhibitor, works by targeting eczema inflammation throughout the body that can lead to dry, itchy, and irritated skin. EBGLYSS is available in a 250 mg/2 mL injection that can be used with or without topical corticosteroids and is dosed as a single monthly maintenance injection following the initial phase of treatment.  

Clinical trial insights 

The approval follows positive results from the ADvocate 1, ADvocate 2, and ADhere clinical trials, which included over 1000 adults and children aged 12 and older. In an average of the ADvocate 1 and ADvocate 2 studies, 38% of patients achieved clear or almost-clear skin at 16 weeks versus 12% with placebo, with 10% demonstrating improvements as early as 4 weeks. Of those who achieved clear or almost-clear skin at Week 16, 77% maintained skin clearance through one year of monthly maintenance treatment. 

Beyond skin clearance, both studies also evaluated itch relief among participants, with 43% reporting meaningful relief at 16 weeks compared to 12% with placebo, and 5% experiencing relief within 3 weeks. Of those who reported itch relief at Week 16, 85% still experienced relief through one year of monthly maintenance treatment. 

Safety profile 

EBGLYSS was generally well-tolerated, with the most common side effects including eye and eyelid inflammation, injection site reactions, and, in some cases, shingles (herpes zoster). Safety outcomes in the maintenance period were generally consistent with the 16-week safety profile. 

Patients should avoid EBGLYSS if they are allergic to lebrikizumab or any of its components. 

Future outlook 

EBGLYSS is expected to be available in the United States in the coming weeks. Lilly will offer a patient support program, including copay assistance, for eligible patients.