Lebrikizumab Shows Sustained AD Control Up to 3 Years in More 80%

More than 80% of adults and adolescents with moderate-to-severe atopic dermatitis who responded to lebrikizumab treatment at Week 16 in the ADvocate 1 and 2 monotherapy trials and continued treatment for up to 3 years experienced sustained skin clearance with monthly maintenance dosing, Almirall S.A. announced.

The new long-term results were part of the ADjoin long-term extension study, which will be presented as a late breaker at the European Academy of Dermatology and Venereology (EADV) Congress from September 25-28 in Amsterdam, Netherlands.  

Lebrikizumab is an interleukin-13 (IL-13) inhibitor that selectively blocks IL-13 signaling with high binding affinity. The cytokine IL-13 is key in atopic dermatitis, driving the type-2 inflammatory cycle in the skin, leading to skin barrier dysfunction, itch, skin thickening and infection.

“These new 3-year clinical data demonstrate the potential this biologic treatment has to provide sustained relief from this disease, offering long-term benefits to people living with this chronic and relapsing condition,” Prof. Dr. med. Diamant Thaçi, Director at the Institute and Comprehensive Centre for Inflammation Medicine, in Lübeck, Germany, said in a press release.

Patients taking lebrikizumab who completed 52 weeks in ADvocate 1 or 2 could enroll in ADjoin for an additional 100 weeks of continued treatment (up to 152 weeks of continuous treatment). Patients in this analysis of the long-term extension trial received treatment either 250 mg every 2 weeks (Q2W) or once monthly (Q4W). The approved maintenance dose of lebrikizumab is 250 mg Q4W. These data presented are part of ADjoin, the long-term extension study of the lebrikizumab trials, and include participants who responded to lebrikizumab treatment at Week 16 from ADvocate 1 and ADvocate 2.

• 84% of these patients taking lebrikizumab once monthly and 83% taking lebrikizumab every 2 weeks maintained clear or almost-clear skin (IGA 0,1) at three years.
• 87% of these patients taking lebrikizumab once monthly and 79% taking lebrikizumab every 2 weeks achieved or maintained at least 90% improvement in disease extent and severity (EASI-90) at 3 years.
• 83% of these patients taking lebrikizumab once monthly and 91% taking lebrikizumab every 2 weeks did not require either high-potency topical corticosteroids or systemic treatments.

“These latest clinical data for lebrikizumab show the potential of this innovative medicine to provide sustained improvement of moderate-to-severe atopic dermatitis, a chronic and often debilitating condition,” said Volker Koscielny, MD, Chief Medical Officer at Almirall. “The data can help inform clinical decision-making and are reassuring, as they show that the vast majority of patients who respond to the treatment will continue to respond over time.”

The safety profile of these patients taking lebrikizumab in ADjoin was consistent with previous lebrikizumab studies, and no new safety signals were observed up to 3 years of treatment. The majority of adverse events were mild or moderate. Less than 3% of patients experienced adverse events leading to treatment discontinuation. The most common side effects of lebrikizumab were conjunctivitis, injection site reactions and shingles (herpes zoster).

Additional data from this clinical study is underway, with results to be presented at future congresses, the press release said.  

Lebrikizumab was approved in the European Union and the UK in 2023, as well as in Japan, Switzerland, and the US in 2024. It is available for prescription in Germany, the UK, Norway, Denmark, Spain, and the Czech Republic.  

Almirall has the exclusive rights to develop and commercialize lebrikizumab for the treatment of dermatology indications, including eczema, in Europe. Almirall's partner Lilly has the rights for development and commercialization of this biologic in the U.S. and the rest of the world outside Europe.