Lebrikizumab Demonstrates Sustained Response for Atopic Dermatitis at 3 Years
The ADjoin long-term extensive study is designed to assess the long-term safety and efficacy of lebrikizumab for moderate-to-severe atopic dermatitis.
Lebrikizumab-Ibkz (Ebglyss) achieved deep and sustained responses for patients with moderate-to-severe atopic dermatitis at 3 years, according to data presented at the American Academy of Dermatology Annual Meeting in Orlando, Florida. The ADjoin (NCT04392154) long-term extensive study was designed to assess the long-term safety and efficacy of lebrikizumab for moderate-to-severe atopic dermatitis.1,2
Data was presented at the American Academy of Dermatology Annual Meeting in Orlando, Florida. | Image Credit: ltyuan | stock.adobe.com
"We hear from patients with moderate-to-severe atopic dermatitis that they struggle with recurring and unpredictable flares and are looking for treatment options that can provide long-term disease control," Mark Genovese, MD, senior vice president of Lilly Immunology Development, said in a news release.1 "Ebglyss is the only first-line biologic treatment option for patients with disease uncontrolled by topicals to report completely clear skin at 3 years with a once monthly maintenance dose. The additional assessments presented at AAD demonstrate significant improvements in disruptive symptoms, such as itch, across a range of patient groups."
Investigators included individuals who completed the sponsored parent studies, and an additional 100 patients who did not complete a participating study were included. The study will also have an addendum to extend the treatment period by an additional 32 weeks to add a treatment arm testing dose every 8 weeks, according to the study information. The outcome included the percentage of individuals who discontinued the study treatment due to adverse events from baseline to week 100. The secondary end points included the percentage of participants with a response of Investigator Global Assessment (IGA) score of 0 or 1 from baseline to week 100 and the percentage of individuals who achieved response of Eczema Area and Severity Index (EASI)-75 from baseline of the parent study to week 100.2
In the study, patients received a maintenance dose of the drug in the 250 mg dosage either every 2 weeks or every 4 weeks and were assessed for depth of responses using IGA 0, EASI 90, and EASI 100. The approved maintenance dose was 250 mg once monthly after taking it every 2 weeks for 4 months after the initial dosing phase. Of those who were responders at week 16, 50% of patients achieved complete skin clearance via EASI 100 or IGA 0 at 3 years, and approximately 87% achieved or maintained EASI at 3 years. Furthermore, 83% of those who responded at week 16 did not require topical corticosteroids or topical calcineurin inhibitors, according to the study results.1
"Health care providers are constantly searching for ways to help patients achieve deep, sustainable improvement in the signs and symptoms of their atopic dermatitis," Raj Chovatiya, MD, PhD, MSCI, clinical associate professor at Rosalind Franklin University, said in the news release.1 "These 3-year data show that raising the bar in atopic dermatitis treatment to long-term total skin clearance was an achievable treatment goal for at least half of Ebglyss week 16 responders, reinforcing its efficacy as a first-line biologic treatment for people with moderate-to-severe atopic dermatitis uncontrolled by topicals."
