Lebrikizumab also demonstrated improvements in absolute response in the skin over 16 weeks in patients with moderate-to-severe AD in the ADvocate 1 and 2 Phase 3 trials.

Lebrikizumab showed clinical improvements in combination with topical corticosteroids (TCS) in adult and adolescent patients with moderate-to-severe atopic dermatitis (AD) that was not adequately controlled with cyclosporine or for whom cyclosporine was not medically advisable, according to research presented at the European Academy of Dermatology and Venereology (EADV) Congress in Berlin.

Patients were assessed over 16 weeks in the Phase 3 ADvantage study. The safety was consistent with the known safety profile of lebrikizumab.

Further data presented at the meeting showed sustained depth of response in patients who participated in the Phase 3 monotherapy Advocate 1 and 2 studies treated with lebrikizumab over 52 weeks. Deep responses, defined as total skin clearance (Investigator's Global Assessment (IGA), Eczema Area and Severity Index (EASI)100) and itch relief (NRS 0,1), were achieved in 20% and 31% of patients by Week 16 respectively and were maintained or increased through Week 52

Lebrikizumab also provided long-term clinically meaningful responses in patients. In a post-hoc analysis of the ADvocate 1 and 2 studies, 84% of patients who had responded to lebrikizumab at Week 16 achieved a clinically meaningful response in at least one domain of the disease (mild signs, symptoms, or quality of life impact) after 52 weeks, and more than 57% achieved response across the three domains.  This represents a status of minimal residual disease.

Improvements in absolute skin response over 16 weeks for patients with moderate-to-severe AD treated with lebrikizumab or placebo were also shared. A post-hoc analysis of the ADvocate1 and ADvocate2 trials showed that, overall, a significantly higher proportion of patients treated with lebrikizumab achieved EASI ≤7 (mild) and EASI ≤1 (clear/almost clear) at Week 16 compared to placebo. This analysis also demonstrated that, regardless of baseline severity, over 50% of patients treated with lebrikizumab 250 mg every other week on monotherapy for 16 weeks achieved an EASI score indicating mild AD and approximately 20% achieved an EASI score indicating clear or almost clear skin.

“Atopic dermatitis (AD) is a debilitating chronic skin condition that can be challenging to manage. Cyclosporine A is the only classical systemic treatment approved in Europe for AD, but its safety may limit long-term use, or it may be contraindicated for some patients,” says Professor. Dr. Ricard B. Warren, Professor of Dermatology and Honorary Consultant Dermatologist at the University of Manchester and Northern Care Alliance NHS Foundation Trust and principal investigator of the ADvantage trial, in a news release. "Although there are an increasing number of treatment options available to ease symptoms and improve outcomes of AD, unfortunately, there are few that offer long-term disease control with a favorable safety profile. The results of this trial reinforce our confidence that lebrikizumab is a promising potential new treatment for patients with moderate-to-severe AD, including those not adequately controlled or ineligible for treatment with cyclosporine A.”

“The new lebrikizumab data set presented at the EADV congress provides further evidence of its efficacy and safety profile. Its anticipated addition to the moderate-to-severe AD treatment arsenal is promising news for both healthcare professionals and patients, including those who do not respond adequately to cyclosporine. Our teams are diligently working to increase our level of knowledge and expand the body of evidence, thereby reinforcing the profile of this potential first-line treatment,”, adds  Karl Ziegelbauer, Ph.D., Chief Scientific Officer at Almirall.

Almirall received a positive CHMP opinion in September, recommending marketing authorization for lebrikizumab for the treatment of adult and adolescent patients (12 years and older with a body weight of at least 40 kg) with moderate-to-severe AD who are candidates for systemic therapy. 

Almirall has licensed the rights to develop and commercialize lebrikizumab for the treatment of dermatology indications, including AD, in Europe. Eli Lilly and Company has exclusive rights for the development and commercialization of the product in the United States and the rest of the world, not including Europe. Almirall expects regulatory decisions for lebrikizumab in moderate-to-severe AD in additional European markets, including the United Kingdom and Switzerland in 2024.

Eli Lilly and Company recently announced that the U.S. Food and Drug Administration (FDA) has issued a complete response letter for the lebrikizumab biologic license application (BLA) for the treatment of moderate-to-severe atopic dermatitis (eczema). The letter cited findings that arose during a multi-sponsor inspection of a third-party, contract manufacturing organization that included the monoclonal antibody drug substance for Lilly's lebrikizumab. The letter stated no concerns about the clinical data package, safety, or label for lebrikizumab.