Ebglyss Demonstrates Sustained Efficacy in Moderate-to-Severe Atopic Dermatitis
Clinical trial results found that a majority of patients with atopic dermatitis who were treated with Ebgylss achieved complete or near complete skin clearance at three years on a single monthly maintenance dose.
Image Credit: Adobe Stock Images/Ольга Тернавская
Results from the ADjoin long-term extension study found that Eli Lilly’s Ebglyss (lebrikizumab-lbkz) produced sustained efficacy in moderate-to-severe atopic dermatitis (AD). These data included patients from the ADvocate 1 and ADvocate 2 monotherapy trials.
Additional data from the ADmirable study showed significant improvements in itch, skin pain, and sleep interference among patients with skin of color, while the ADapt trial demonstrated similar results in patients who were previously treated with Dupixent (dupilumab). Full results from these trials will be presented during the American Academy of Dermatology Annual Meeting (AAD), which is currently taking place in Orlando.1
"Healthcare providers are constantly searching for ways to help patients achieve deep, sustainable improvement in the signs and symptoms of their atopic dermatitis," said Raj Chovatiya, MD, PhD, MSCI, clinical associate professor, Rosalind Franklin University Chicago Medical School, founder, director, Center for Medical Dermatology + Immunology Research, in a press release. "These three-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."
ADjoin evaluated the long-term safety and efficacy of Ebglyss for up to 100 weeks and included patients who completed any of the previous studies; however, patients who weren’t in one of the previous studies were also permitted to enroll. ADmirable was a Phase IIIb open-label, 24-week study evaluating the safety and efficacy of Ebglyss in adults and adolescents. During the study, patients received a dose of 500 mg followed by 250 mg at two weeks, which continued every two weeks until Week 16.
ADapt was a Phase IIIb open-label,24-week study in adults and adolescents, in which patients were administered the same dose levels as the ADmirable study after discontinuing dupilumab.
Results found that among patients who responded by week 16, 50% achieved clear skin at three years, while 87% achieved almost clear skin. The findings also show that 83% of patients in the ADjoin study didn’t need concomitant therapies. In ADmirable, around 60% of patients experienced significant itch improvements, with 30% also experiencing a reduction in sleep loss as a result. In ADapt, 75% of patients reported improvements in skin pain, 62% experienced itch relief, and 42% experienced a reduction in sleep loss.
Most adverse events (AEs) related to the studies were mild or moderate, with no discontinuations. AEs related to treatment were conjunctivitis and injection-site reactions. The safety profile of Ebglyss was consistent with previous Phase III studies.1
According to the National Eczema Association, AD is the most common form of eczema. Around 16.5 million adults and 9.6 million children in the United States are currently living with it. Eighty percent of people with AD first experience it before six years of age; however, one in four adults also report experiencing their first symptoms as they get older.2
"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," said Mark Genovese, MD, SVP, Lilly immunology development, in the press release. "Ebglyss is the only first-line biologic treatment option for patients with disease uncontrolled by topicals to report completely clear skin at three 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."
References
1. Lilly's EBGLYSS® (lebrikizumab-lbkz) single monthly maintenance injection achieved completely clear skin at three years in half of patients with moderate-to-severe atopic dermatitis. PR Newswire. March 7, 2025. Accessed March 7, 2025. https://prnmedia.prnewswire.com/news-releases/lillys-ebglyss-lebrikizumab-lbkz-single-monthly-maintenance-injection-achieved-completely-clear-skin-at-three-years-in-half-of-patients-with-moderate-to-severe-atopic-dermatitis-302395263.html
2. Eczema Stats. NEA. Accessed March 7, 2025. https://nationaleczema.org/eczema-facts/
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