Positive results for Almirall’s lebrikizumab in atopic dermatitis published in NEJM and BJD

Almirall’s lebrikizumab was associated with significant improvements in moderate-to-severe atopic dermatitis symptoms, according to phase 3 results recently published in the New England Journal of Medicine (NEJM) and the British Journal of Dermatology (BJD).

Typically referred to as eczema, atopic dermatitis is one of the most common inflammatory skin diseases, affecting up to 4.4% of adults in the EU.

The disease causes itchy, red, swollen and cracked skin, usually affecting the folds of the arms, back of the knees, hands, feet, face and neck.

The identically designed ADvocate1 and ADvocate2 trials evaluated the efficacy and safety of lebrikizumab as a monotherapy in adult and adolescent patients with moderate-to-severe atopic dermatitis versus placebo. Week 16 and week 52 results were published in the NEJM and BJD, respectively.

Both studies met the co-primary endpoints, with a significantly higher proportion of patients in the lebrikizumab groups achieving clear or almost clear skin, as well as 75% or greater skin improvement.

For patients who achieved a clinical response at week 16 through one year of treatment, lebrikizumab maintained robust and durable efficacy in skin clearance and itch.

The results delivered were similar when dosed once every four weeks or once every two weeks, the company said.

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

“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.”

Karl Ziegelbauer, Almirall’s chief scientific officer, said the company was “delighted” by the publication of the data.

“Awaiting approval in Europe later this year, we are still working toward the market launch of this treatment, convinced of its potential to become a best-in-class treatment for atopic dermatitis,” he said.

Almirall has licensed the rights to develop and commercialise lebrikizumab for use as a treatment of dermatology indications, including atopic dermatitis, in Europe, while Eli Lilly has exclusive rights for the development and commercialisation of lebrikizumab in the US and the rest of the world.