Ebglyss Achieves Clear Skin in Atopic Dermatitis

These findings from the ADjoin long-term extension study will be presented at the American Academy of Dermatology (AAD) Annual Meeting, in Orlando.

Ebglyss is an interleukin-13 (IL-13) inhibitor that selectively blocks IL-13 signaling with high binding affinity. The cytokine IL-13 is a primary cytokine in atopic dermatitis, driving the type-2 inflammatory cycle in the skin, leading to skin barrier dysfunction, itch, skin thickening and infection. Three-year depth of response data being presented are part of ADjoin, the long-term extension study of the Ebglyss trials, and include participants who responded to Ebglyss treatment at Week 16 from ADvocate 1 and ADvocate 2 monotherapy trials. Patients received a maintenance dose of 250 mg Ebglyss either every two weeks or once monthly (every four weeks) and were assessed for depth of response using IGA 0, EASI 90 and EASI 100. The approved maintenance dose of Ebglyss is 250 mg once monthly, after taking Ebglyss every two weeks for the four-month initial dosing phase (or later once achieving adequate clinical response). Of the patients who responded to treatment at Week 16 and were receiving once-monthly maintenance dosing, 50% of patients achieved complete skin clearance (EASI 100 or IGA 0) at three years. Additionally, 87% achieved or maintained almost-clear skin (EASI 90) at three years. Over 83% of Week 16 responders taking Ebglyss did not require the use of concomitant therapies such as topical corticosteroids (TCS) or topical calcineurin inhibitors (TCI) for the duration of the ADjoin study.

"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, M.D., Ph.D., MSCI, Clinical Associate Professor, Rosalind Franklin University Chicago Medical School, Founder and Director of the Center for Medical Dermatology + Immunology Research. "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."

Additional study assessments conducted in patients with skin of color (ADmirable) and patients who were previously treated with dupilumab (ADapt) will also be presented at the meeting. Improvements of itch, skin pain (discomfort and soreness) and itch interference on sleep were measured using clinically meaningful thresholds for the validated patient-reported outcomes.  

In ADmirable, a first-of-its-kind Ebglyss study specifically designed for people with skin of color and moderate-to-severe atopic dermatitis, nearly 60% of patients achieved significant improvement in itch (Pruritus NRS ≥4-point improvement from baseline) and skin pain (≥4-point improvement from baseline) at Week 16 (58% and 59% respectively). Over 30% of patients saw a reduction in sleep loss due to itch (≥2-point improvement from baseline in Sleep-Loss Scale) at Week 16.

In ADapt, a study of patients taking Ebglyss who were previously treated with dupilumab, 75% achieved significant improvement in skin pain (≥4-point improvement from baseline) and 62% achieved significant improvement in itch (Pruritus NRS ≥4-point improvement from baseline) at Week 24. Forty-two percent of patients saw a reduction in sleep loss due to itch (≥2-point improvement in Sleep-Loss Scale) at Week 24.

The reported endpoints for all studies were as observed.

The safety profile in these studies was consistent with previous Ebglyss Phase III studies in patients with moderate-to-severe atopic dermatitis, regardless of dose frequency, and no new safety signals were observed. The majority of adverse events were mild or moderate and did not lead to discontinuation. Reported treatment-related side effects in the studies were conjunctivitis and injection-site reactions.

"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, M.D., senior vice president of Lilly Immunology development. "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."

About ADjoin - ADjoin (NCT04392154) evaluated the long-term safety and efficacy of Ebglyss treatment in patients with moderate-to-severe atopic dermatitis for up to 100 weeks (up to 152 weeks of continuous treatment with the parent studies). Patients taking Ebglyss who completed any of the parent studies (ADvocate 1 and 2 monotherapy trials, ADhere, ADore, ADopt-VA) were able to enroll in ADjoin. The ADhere parent study included patients taking topical corticosteroids with Ebglyss as a combination therapy. Patients could also enroll directly into ADjoin without participating in a parent study. Patients in this analysis of the long-term extension trial received a maintenance dose of either Ebglyss 250 mg every two weeks or once monthly.

About ADmirable - ADmirable (NCT05372419) is a Phase IIIb, open-label, 24-week study evaluating the safety and efficacy of Ebglyss in adults and adolescents (12 to less than 18 years of age and weighing ≥40 kg) with skin of color and moderate-to-severe atopic dermatitis and defining innovative objective measures of pigment, and post-inflammatory hyper and hypopigmentation. Patients enrolled in the ADmirable study received a starting dose of Ebglyss 500 mg subcutaneously initially and at two weeks followed by 250 mg every two weeks until Week 16. IGA 0,1 or EASI-75 responders at Week 16 received 250 mg once monthly and non-responders continued on 250 mg every two weeks until Week 24. Patients were allowed to stay on low- and mid-potency topical corticosteroids.

About ADapt - ADapt (NCT05369403), is an open-label, Phase IIIb, 24-week study that evaluated the efficacy and safety of Ebglyss in adults and adolescents (12 to less than 18 years of age and weighing ≥40 kg) with moderate-to-severe atopic dermatitis who were previously treated with dupilumab. After discontinuing dupilumab, patients were treated with Ebglyss and received a starting dose of 500 mg subcutaneously initially and at two weeks followed by 250 mg every two weeks until Week 16. IGA 0,1 or EASI-75 responders at Week 16 received 250 mg once monthly and non-responders continued on 250 mg every two weeks until Week 24. Patients were allowed to stay on low- and mid-potency topical corticosteroids.