The New England Journal of Medicine (NJEM) and British Journal Dermatology (BJD) have published results from two Phase III trials evaluating lebrikizumab which show statistically significant and clinically meaningful improvements in patients with moderate-to-severe atopic dermatitis.

ADvocate1 (NCT04146363) and ADvocate2 (NCT04178967) are two identical 52-week randomised, double-blind, placebo-controlled, parallel-group Phase III studies. Results at 16 weeks and 52 weeks respectively demonstrated that both studies, which included 851 patients, met the co-primary endpoints of IGA 0/1 and EASI 75. Improvements on itch and the interference of itch on sleep, which were secondary endpoints, were also met at week 16.

“People living with moderate to severe atopic dermatitis need more treatment options that are tailored to their unique needs and preferences,” said Jonathan Silverberg, professor of Dermatology at George Washington University School of Medicine & Health Sciences and co-investigator of the studies.

“In clinical trials, patients experienced significantly clearer skin and less interference with sleep due to itch when taking lebrikizumab compared to placebo. These results are very promising for patients with atopic dermatitis.”

Lebrikizumab, a novel monoclonal antibody that binds to interleukin 13 (IL-13) and blocks its downstream signalling, provided robust long-lasting efficacy in skin clearance and itch in patients with a clinical improvement at week 16 through monthly maintenance dosing over a year of treatment.

In January 2023, JAMA Network published positive results from a Phase III trial evaluating lebrikizumab in combination with topical corticosteroid (TCS) therapy for moderate-severe AD. Added to Almirall’s results in the NJEM and BJD, lebrikizumab’s potential for a disease that affects approximately 6.6 million adults in the US is becoming clear. In Europe, up to 4.4% of adults have atopic dermatitis and 30% have moderate-to-severe disease.

Almirall, headquartered in Barcelona, Spain has licensed the rights to develop and commercialise lebrikizumab for AD treatment in Europe, whilst Eli Lilly has the equivalent exclusive rights for lebrikizumab in the United States and the rest of the world.