Almirall, Lilly’s Ebglyss maintains skin clearance for up to four years in atopic dermatitis

Almirall (BME: ALM) presented interim data from the Phase IIIb ADlong study showing that lebrikizumab maintained skin clearance and itch control for up to four years in patients with moderate-to-severe atopic dermatitis, extending the durability evidence for the IL-13 inhibitor marketed under the trade name Ebglyss. The findings, disclosed at the American Academy of Dermatology Annual Meeting in Denver on March 27, 2026, add to a growing body of long-term data in a therapeutic class where sustained disease control remains a central question for clinicians and payers. Almirall is partnered on lebrikizumab’s global development with Eli Lilly.

ADlong Phase IIIb results

ADlong is an open-label extension study evaluating lebrikizumab 250 mg every four weeks in adults and adolescents with moderate-to-severe atopic dermatitis. The interim analysis included 174 patients who had completed prior lebrikizumab trials, representing up to four years of continuous treatment.

At week 48, 94% of patients achieved EASI-75, 75% reached EASI-90, and 68% achieved an Investigator’s Global Assessment score of 0 or 1. Seventy-eight percent reported meaningful itch reduction. Most patients were maintained on monotherapy without topical corticosteroids.

The responder-enriched design and observed-case analysis may overestimate efficacy, as only patients who completed earlier studies were included. Safety was consistent with prior studies, with mainly mild to moderate adverse events and no new safety signals reported.

The development context for lebrikizumab

Lebrikizumab is a monoclonal antibody that binds IL-13, a type 2 cytokine that drives skin barrier dysfunction, inflammation, and pruritus in atopic dermatitis. By blocking IL-13 from engaging its receptor complex, lebrikizumab inhibits downstream signaling without broader immunosuppression. This selective mechanism distinguishes it from dupilumab (Dupixent, Sanofi/Regeneron), which blocks both IL-4 and IL-13 through the IL-4 receptor alpha subunit, and from oral JAK inhibitors such as upadacitinib (Rinvoq, AbbVie) and abrocitinib (Cibinqo, Pfizer), which act on intracellular kinase pathways.

The atopic dermatitis biologic market is anchored by dupilumab, first approved in 2017, with extensive real-world and long-term extension data. Tralokinumab (Adtralza/Adbry, LEO Pharma), the other approved IL-13 inhibitor, was authorized in 2021. Lebrikizumab gained approval in both Europe and the US in 2024, with Eli Lilly retaining development and commercialization rights outside Europe.

The EASI-75 rate of 94% reported in ADlong appears numerically higher than long-term extension data reported for dupilumab and tralokinumab in similar open-label settings. However, cross-trial comparisons are limited by differences in study design, patient selection, duration, and analytical methods. The ADlong population’s enrichment for prior responders makes direct comparison to other extension studies particularly difficult. No head-to-head trials between lebrikizumab and dupilumab or tralokinumab have reported results.

The oral JAK inhibitors occupy a different position in the treatment algorithm, generally reserved for patients who have not responded to or cannot tolerate biologics, partly due to safety considerations including cardiovascular and thromboembolic risks associated with the JAK class.

The ADlong study is ongoing and will continue for an additional year of treatment, with further data expected to clarify the durability of response and long-term safety. Almirall and Eli Lilly are also conducting Phase III trials in related indications, including perennial allergic rhinitis (NCT06339008) and chronic rhinosinusitis with nasal polyps (NCT06338995), as well as additional atopic dermatitis studies.