Nearly 80% of patients with moderate-to-severe atopic dermatitis maintained clear or almost clear skin with lebrikizumab monthly maintenance dosing at two years.

Patients with moderate-to-severe atopic dermatitis who continued treatment with investigational lebrikizumab for up to two years experienced sustained skin clearance, itch relief and reduced disease severity with monthly maintenance dosing, according to data from the ADjoin long-term extension study presented at the 43rd Annual Fall Clinical Dermatology Conference happening in Las Vegas.

"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," says study author Emma Guttman-Yassky, MD, PhD, 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, in a news release. "Long-term data is critical for healthcare providers making treatment decisions with patients. These impressive two-year data underscore the lasting impact this potential first-line biologic treatment option may provide for people living with this disruptive disease." 

Lebrikizumab is an interleukin-13 (IL-13) inhibitor. Lilly has exclusive rights for development and commercialization of lebrikizumab in the U.S. and the rest of the world outside Europe. Lilly's partner Almirall has licensed the rights to develop and commercialize lebrikizumab for the treatment of dermatology indications, including eczema, in Europe.  

ADjoin is the two-year extension of the lebrikizumab monotherapy trials ADvocate 1 and ADvocate 2 and ADhere, the combination trial with topical corticosteroids. Patients taking lebrikizumab who achieved IGA 0,1 or EASI-75 at 16 weeks in ADvocate 1 and 2 and ADhere were enrolled in ADjoin. Patients in the long-term extension trial received either lebrikizumab 250-mg every two weeks or monthly.

In ADjoin, lebrikizumab provided durable efficacy in skin and itch outcomes through two years of treatment with both monthly and two-week dosing.

The safety profile of lebrikizumab in ADjoin was consistent with previous lebrikizumab studies in patients with moderate-to-severe atopic dermatitis, and no new safety signals were observed up to two years of treatment. In ADjoin, 62% of patients reported adverse events (AEs), most of which were mild or moderate in severity. The most common side effects of lebrikizumab were conjunctivitis, injection site reactions and shingles (herpes zoster). Less than three percent of patients experienced AEs leading to treatment discontinuation.

"Results from ADjoin reinforce the strong efficacy and safety profile of lebrikizumab seen in the other Phase 3 atopic dermatitis trials. These data also further our understanding of the long-lasting benefits of lebrikizumab as a potential first-line biologic treatment for patients," adds Lotus Mallbris, MD, PhD, senior vice president of global immunology development and medical affairs at Lilly. "We look forward to working with global regulatory authorities to bring this important medicine to patients." 

The two-year long-term extension data build on the positive one-year results from the monotherapy studies previously published in British Journal of Dermatology as well as the 16-week monotherapy data published in The New England Journal of Medicine. 

"The two-year data from the ADjoin study further validate the promising efficacy and safety profile of lebrikizumab in people with moderate-to-severe atopic dermatitis" says Karl Ziegelbauer, PhD, Chief Scientific Officer at Almirall S.A. "These results demonstrated that monthly maintenance dosing of lebrikizumab provided long-lasting relief from the distressing symptoms of this chronic disease, bringing us one step closer to offering a first-line biologic treatment option."