New Data: Almirall's EBGLYSS® (Lebrikizumab) Offers 3-Year Control for 80% With Moderate-to-Severe Atopic Dermatitis

In a notable announcement from Barcelona, Spain, dated September 25, 2024, Almirall S.A. shared promising long-term results from their ADjoin extension study on lebrikizumab. This data, set to be showcased at the European Academy of Dermatology and Venereology (EADV) Congress in Amsterdam, reveals that over 80% of adults and adolescents with moderate-to-severe atopic dermatitis maintained skin clearance for up to three years with monthly doses of lebrikizumab.

Lebrikizumab functions as an interleukin-13 (IL-13) inhibitor, playing a crucial role in atopic dermatitis by interrupting IL-13 signaling. This cytokine is essential in the inflammatory cycle of the skin, contributing to barrier dysfunction, itching, thickening, and susceptibility to infections.

Prof. Dr. med. Diamant Thaçi, Director at the Institute and Comprehensive Centre for Inflammation Medicine in Lübeck, Germany, emphasized the significance of these findings. He noted that moderate-to-severe atopic dermatitis severely impacts patients' lives, and the three-year clinical data illustrate the potential of lebrikizumab to offer long-term relief.

Patients who successfully completed 52 weeks of treatment in the ADvocate 1 or 2 trials were eligible to join the ADjoin study, receiving lebrikizumab for an additional 100 weeks. Participants were administered either 250 mg biweekly or monthly. The approved monthly maintenance dose is 250 mg. The data indicated that the majority of patients who responded positively at Week 16 continued to benefit throughout the study.

Dr. Volker Koscielny, Chief Medical Officer at Almirall, highlighted that the sustained improvement in patients underlines the promise of lebrikizumab as an effective long-term treatment for moderate-to-severe atopic dermatitis. He pointed out that the consistent positive response over time offers reassurance and aids in clinical decision-making.

Throughout the ADjoin study, the safety profile of lebrikizumab was consistent with earlier trials, and no new safety concerns were identified over the three years. Most adverse events were mild or moderate; less than three percent of participants discontinued treatment due to adverse effects. Common side effects included conjunctivitis, injection site reactions, and shingles.

Additional data from this study are being prepared for future presentations. Lebrikizumab received approval in the European Union and the UK in 2023, followed by Japan, Switzerland, and the U.S. in 2024. It is now available for prescription in several European countries including Germany, the UK, Norway, Denmark, Spain, and the Czech Republic.

Mark Genovese, M.D., Senior Vice President of Immunology Development at Lilly, remarked on the severe implications of untreated atopic dermatitis. He highlighted that lebrikizumab’s targeted approach to IL-13 offers significant relief from inflammation and symptoms, demonstrating its long-term efficacy for patients in need.

Almirall holds exclusive rights to develop and commercialize lebrikizumab for dermatological uses in Europe, while Lilly handles its development and commercialization in the U.S. and other regions outside Europe.

The ADjoin study (NCT04392154) assessed the long-term safety and efficacy of EBGLYSS (lebrikizumab) in patients with moderate-to-severe atopic dermatitis over a period extending up to 152 weeks. This included patients from various parent studies like ADvocate 1 and 2, ADhere, ADore, and ADopt-VA, as well as new enrollees.

Lebrikizumab is a monoclonal antibody engineered to neutralize IL-13 with high specificity and slow dissociation. By binding to IL-13, it prevents the formation of the receptor complex necessary for IL-13 signaling, which is central to the pathology of eczema.

The Phase 3 program for lebrikizumab includes several global studies involving over 1,300 patients, aiming to provide comprehensive data on its efficacy and safety. Future results from related studies are anticipated to be shared in 2024 and early 2025.

Almirall, headquartered in Barcelona and publicly traded on the Spanish Stock Exchange, focuses on medical dermatology and collaborates with experts to develop innovative treatments that improve patients' lives. Founded in 1944, the company continues to expand its reach, ensuring its products are available in over 100 countries.