Results from the ADjoin long-term extension study (NCT04392154) show that more than 80% of patients with moderate-to-severe atopic dermatitis (AD) who responded to treatment with Ebglyss (lebrikizumab-lbkz) in the ADvocate 1 and 2 trials were able to maintain sustained skin clearance for up to three years with monthly dosing.1,2 Ebglyss, a biologic drug that targets the interleukin (IL)-13 pathway for systemic inflammation responsible for the dry, itchy, and irritated skin associated with AD, was approved by the FDA on September 13, 2024, for moderate-to-severe AD in individuals aged 12 years and older who weigh at least 88 lbs.3
“The chronic and persistent signs and symptoms of atopic dermatitis affect patients’ daily lives, highlighting the need for a treatment that can provide sustained, long-term relief,” ADjoin trial investigator and senior author Eric Simpson, MD, MCR, professor of dermatology and director of clinical research at Oregon Health & Science University School of Medicine in Portland, Oregon, said in a press release. “These three-year results provide compelling evidence of durable efficacy and a consistent safety profile, offering further long-term evidence for health care providers seeking a new biologic treatment option for their patients.”1
Both ADvocate 1 and ADvocate 2 were 52-week, randomized, double-blind, placebo-controlled, parallel-group, global, Phase III trials that analyzed Ebglyss monotherapy in patients with moderate-to-severe AD. Patients were administered Ebglyss 500 mg at baseline and at two weeks, followed by 250 mg or placebo every two weeks.
Patients experiencing a clinical response after 16 weeks were re-randomized to receive the treatment every two weeks or four weeks, or placebo for an additional 36 weeks. The ADhere parent trial enrolled patients taking topical corticosteroids with Ebglyss as a combination therapy.
ADjoin analyzed the long-term safety and efficacy of Ebglyss in patients with moderate-to-severe AD for up to 100 weeks—or up to 152 weeks of continuous treatment with the parent trials. Patients who completed any of the parent trials of Ebglyss were able to enroll in ADjoin. Patients were also able to enroll directly into the ADjoin trial without participation in the parent trials. Those enrolled in the ADjoin long-term extension trial received either Ebglyss 250 mg every two weeks or once monthly.
The results show that 84% of patients administered Ebglyss once monthly and 83% administered the drug every two weeks were able to maintain clear or almost-clear skin (IGA 0,1) at three years. Of these patients, 87% of the once monthly dosing cohort and 79% of the every two weeks dosing cohort achieved or maintained at least a 90% improvement in disease extent and severity (EASI-90) at three years. Further, 83% of the once monthly dosing cohort and 91% of the every two weeks dosing cohort did not need either high-potency topical corticosteroids or systemic treatments.
In terms of safety, the profile of Ebglyss in the ADjoin trial was consistent with prior trials of the drug, with no new safety signals reported with up to three years of treatment. Most adverse events (AEs) were deemed mild or moderate, with fewer than 3% of patients reporting AEs that caused treatment discontinuation. The most common AEs associated with Ebglyss were conjunctivitis, injection site reactions, and herpes zoster.
“Without adequate treatment, atopic dermatitis can leave people struggling with uncontrolled symptoms,” said Mark Genovese, MD, senior vice president of Immunology Development at Lilly, said in a press release. “Ebglyss selectively targets IL-13, one of the main drivers of inflammation in eczema. These three-year data demonstrate that Ebglyss given once monthly provides durable symptom relief for patients who need it most.”1
References
1. New data show Lilly’s EBGLYSS™ (lebrikizumab-lbkz) provided sustained disease control for up to three years in more than 80% of adults and adolescents with moderate-to-severe atopic dermatitis. News release. Eli Lilly. September 25, 2024. Accessed September 25, 2024. https://investor.lilly.com/news-releases/news-release-details/new-data-show-lillys-ebglysstm-lebrikizumab-lbkz-provided
2. Long-term Safety and Efficacy Study of Lebrikizumab (LY3650150) in Participants With Moderate-to-Severe Atopic Dermatitis (ADjoin) (ADjoin). ClinicalTrials.gov. Updated May 9, 2024. Accessed September 25, 2024. https://clinicaltrials.gov/study/NCT04392154
3. FDA Approves Lilly’s EBGLYSS™ (lebrikizumab-lbkz) for Adults and Children 12 Years and Older with Moderate-to-Severe Atopic Dermatitis. Lilly. September 13, 2024. Accessed September 25, 2024. https://investor.lilly.com/news-releases/news-release-details/fda-approves-lillys-ebglysstm-lebrikizumab-lbkz-adults-and