Lebrikizumab Maintains Efficacy Through 4 Years in Moderate-to-Severe Atopic Dermatitis: AAD 2026

Long-term data from the ADlong Phase 3b open-label extension study show that lebrikizumab-lbkz (EBGLYSS, Eli Lilly) sustained meaningful disease control for up to 4 years in adult and adolescent patients with moderate-to-severe atopic dermatitis, according to interim findings presented at the American Academy of Dermatology (AAD) Annual Meeting (March 27–31, Denver).¹

"There is still an unmet need for people with moderate-to-severe atopic dermatitis who frequently experience unpredictable flares and are in need of treatment options that go beyond just symptomatic relief and address the underlying inflammation driving skin symptoms and persistent itch," Emma Guttman-Yassky, MD, PhD, The Waldman Professor and Health System Chair, Department of Dermatology at the Icahn School of Medicine at Mount Sinai in New York, said in a press release. "These four-year findings reinforce that EBGLYSS has the potential to deliver durable disease control, helping patients flare less with or without topicals."²

Study design. ADlong (NCT05916365) is evaluating the long-term safety and efficacy of lebrikizumab 250 mg administered every 4 weeks (Q4W) for a total of 108 weeks. The study enrolled adult and adolescent patients (ages 12–17, weighing ≥40 kg) from select European countries who had completed the 100-week ADjoin extension study. Eligible patients included those who had completed the ADore trial (52 weeks), the ADhere trial (16 weeks), and Week 16 responders who completed the ADvocate 1 and 2 trials (52 weeks). All 174 patients in the current analysis received open-label lebrikizumab 250 mg Q4W regardless of their prior dosing regimen in ADjoin (Q2W or Q4W). Intermittent use of topical rescue medications and short-term systemic treatments was permitted.

Efficacy outcomes. At up to 4 years of continuous treatment, reported as observed, efficacy results were as follows:

• EASI-75 (≥75% reduction in Eczema Area and Severity Index from baseline): 94%
• EASI-90 (≥90% reduction in EASI from baseline): 75%
• IGA 0,1 (Investigator's Global Assessment score of 0 ["clear"] or 1 ["almost clear"]): 68%
• Pruritus NRS ≤4 (Numeric Rating Scale, 0–10): 78%

Most patients (77%) were on lebrikizumab monotherapy, 80% achieved outcomes without topical corticosteroids, and 80% maintained results on the once-monthly maintenance dosing schedule. A separate post-hoc analysis of the ADjoin study, presented at Maui Derm Hawaii 2026, found that stable EASI-75 responders experienced fewer than 1 flare per patient per year with lebrikizumab monthly maintenance monotherapy.

Safety. The safety profile observed during the first year of ADlong was consistent with the established profile for lebrikizumab in moderate-to-severe atopic dermatitis. No new safety signals were identified, and the majority of adverse events were mild or moderate in severity and did not lead to treatment discontinuation. Treatment-related adverse events included conjunctivitis (6.9%) and injection-site reactions (0.6%).

Background. Lebrikizumab is a monoclonal antibody that selectively targets and neutralizes IL-13, a primary cytokine implicated in the pathophysiology of atopic dermatitis. It binds IL-13 at a site overlapping with the IL-4Rα subunit of the IL-13Rα1/IL-4Rα heterodimer, blocking downstream signaling with high binding affinity and a slow dissociation rate. The drug received approval in the US, Japan, and Canada in 2024 and in the European Union in 2023. It is indicated for adults and children aged ≥12 years weighing ≥40 kg (88 lbs) with moderate-to-severe atopic dermatitis not adequately controlled with topical prescription therapies.

The recommended initial dosing regimen is 500 mg (two 250 mg injections) at Weeks 0 and 2, followed by 250 mg every 2 weeks until Week 16 or until adequate clinical response is achieved, after which maintenance dosing is 250 mg every 4 weeks.

The ADlong study is ongoing, with an additional year of treatment planned.

References:

1. Weidinger S, et al. Efficacy and Safety of Lebrikizumab is Maintained up to 4 Years in Patients With Moderate-to-Severe Atopic Dermatitis: first year of ADlong Long-Term Extension Trial. Presented at: American Academy of Dermatology Annual Meeting, March 2026, Denver, CO.
2. Eli Lilly. Lilly's EBGLYSS (lebrikizumab-lbkz) delivered up to four years of durable disease control for patients with moderate-to-severe atopic dermatitis. News release. March 27, 2026. Accessed March 27, 2026. https://investor.lilly.com/news-releases/news-release-details/lillys-ebglyss-lebrikizumab-lbkz-delivered-four-years-durable