Eli Lilly announces positive phase 3 results for lebrikizumab for atopic dermatitis

Eli Lilly reported lebrikizumab was safe and efficacious in improving moderate to severe atopic dermatitis in combination with topical corticosteroids in the company’s third phase 3 ADhere trial, according to a company press release.

At week 16 of the placebo-controlled trial, lebrikizumab (Eli Lilly/Almirall) achieved primary endpoints including a clear or almost clear Investigator Global Assessment score with a reduction of at least 2 points from baseline, as well as a 75% change from baseline in the Eczema Area and Severity Index score. Additionally, the interleukin-13 inhibitor combined with topical corticosteroids achieved all secondary endpoints, including improvement in skin clarity, itch relief, interference of itch with sleep and quality of life.

Researchers also found lebrikizumab combination therapy was safe, with the most common adverse events being conjunctivitis and headache. The results were consistent with the safety results of the ADvocate 1 and ADvocate 2 16-week monotherapy studies, which were announced in August 2021.

"AD is often complex and challenging to treat, as many patients need help controlling their symptoms when topical steroids alone are not enough," Eric Simpson, MD, MCR, professor of dermatology and director of clinical research at Oregon Health & Science University in Portland and a principal investigator of the ADhere study, said in the release. "I'm encouraged by the aggregate efficacy and safety data which have demonstrated the potential for lebrikizumab as both monotherapy and combination therapy to address unmet needs and improve care for people living with persistent itch and inflamed skin caused by AD."

Once the ADvocate 1 and ADvocate 2 monotherapy trials are completed, Lilly and Almirall plan to begin regulatory submissions in 2022.