Almost 80% of patients in an extension study maintained clear or almost clear skin, and 90% of patients saw continued improvements in itch.
Patients with moderate-to-severe atopic dermatitis who were treated with lebrikizumab for up to two years maintained skin clearance and itch relief. These results were seen with patients who received either lebrikizumab 250-mg every two weeks or monthly. These findings from the ADjoin long-term extension study were presented recently at the 43rd Annual Fall Clinical Dermatology Conference.
Atopic dermatitis is a chronic skin disease characterized by inflammation of the skin and skin barrier defects, and it can cause an abnormal immune response beneath the skin. About one in three adults and one in three children and adolescents have moderate-to-severe atopic dermatitis.
Recent research indicates that Interleukin-13 (IL-13) is overexpressed in atopic dermatitis and modifies the skin microbiome. This causes itching, skin thickening, and susceptibility to infection. Developed by Eli Lilly, lebrikizumab is a monoclonal antibody that blocks IL-13.
“Lebrikizumab, administered with a once-monthly dose following an induction phase, demonstrated efficacy for patients with moderate-to-severe atopic dermatitis, offering sustained relief from some of the most distressing signs and symptoms of the disease,” Emma Guttman-Yassky, M.D., Ph.D., The Waldman Professor and Health System Chair, Department of Dermatology, director, Center of Excellence in Eczema and the Laboratory for Inflammatory Skin Diseases at the Icahn School of Medicine at Mount Sinai in New York, said in a press release.
ADjoin is the two-year extension of the lebrikizumab monotherapy trials ADvocate 1, ADvocate 2 and ADhere. ADvocate 1 and 2 are 52-week were placebo-controlled phase 3 studies designed to evaluate lebrikizumab as monotherapy in adult and adolescent patients. ADhere was a 16-week placebo-controlled phase 3 study to evaluate lebrikizumab in combination with topical corticosteroids.
Almost 80% of patients in ADjoin maintained clear or almost clear skin, and 90% of patients saw continued improvements in itch. No new safety issues were seen with up to two years of treatment. In ADjoin, 62% of patients reported adverse events, most of which were mild or moderate in severity. The most common side effects were conjunctivitis, injection site reactions and shingles. Less than 3% of patients experienced adverse events leading to treatment discontinuation.
The ADvocate 1 and 2 and ADhere studies formed the basis Lilly’s biologic license application (BLA) for lebrikizumab to treat patients with moderate-to-severe atopic dermatitis. But in early October, Lilly announced that the FDA had issued a complete response letter for the application. At issue are findings from the agency’s inspection of a third-party manufacturing company. The FDA indicated there were no concerns about the safety or labeling of lebrikizumab.
Lilly is currently discussing next steps with the contract manufacturing organization and the FDA to understand the timeline, a company spokesperson said.
“We remain confident in lebrikizumab’s efficacy and safety profile, which is supported by our pivotal phase 3 clinical data, and we are working closely with the third-party, contract manufacturing organization and the FDA to resolve the findings,” the spokesperson said. “We are committed to launching lebrikizumab in the United States as a new first-line biologic treatment of adults and children 12 years of age and older with moderate-to-severe atopic dermatitis (eczema) uncontrolled on topical therapies.”
The two-year long-term extension data build on one-year results from the monotherapy studies published in June 2023 in the British Journal of Dermatology, as well as the 16-week monotherapy data published in March 2023 in The New England Journal of Medicine. In May 2023, Lilly presented data from the ADvocate 1, ADvocate 2 and ADhere studies at the 5th annual Revolutionizing Atopic Dermatitis (RAD) Congress. A post-hoc analysis based on data from the 16-week induction periods of the three studies showed a 58% to 73% of patients treated with lebrikizumab experienced improvement or clearance of face or hand dermatitis.
Lilly has also initiated a clinical study of lebrikizumab in people of color living with atopic dermatitis to generate additional data. It is expected to be completed in March 2024.