Clearer skin on the face and hands lasted 1 year into treatment.
Lebrikizumab (Eli Lilly) provides stable and long-lasting results in patients with moderate-to-severe atopic dermatitis (AD)—also called eczema—according to the results of secondary analyses from a phase 3 clinical development program (ADvocate 1, ADvocate 2, ADherestudies) that were presented at the 5th annual Revolutionizing Atopic Dermatitis (RAD) Congress. In a 16 week post-hoc analysis of all the trials, 58% to 73% of adolescent and adult patients had improved or cleared face or hand dermatitis.
"The fluctuating symptoms and unpredictable nature of AD, along with limited medicines that can adequately manage long-term uncontrolled symptoms, represent major challenges in the treatment of this chronic disease," said Jenny Murase, MD, associate clinical professor of Dermatology, University of California San Francisco and director of Medical Dermatology Consultative Services and Patch Testing, Palo Alto Foundation Medical Group, in the press release.
In the phase 3 development program, ADvocate 1 and ADvocate 2 are 1-year randomized, double-blind, placebo-controlled, parallel-group, global, phase 3 studies that evaluated monotherapy lebrikizumab in adolescent and adult patients with moderate-to-severe AD.
The primary outcomes were clear skin (0) or almost clear skin (1) according to the Investigator Global Assessment (IGA) with a 2-point reduction from baseline, and at least a 75% change from baseline in the Eczema Area and Severity Index (EASI-75) score at 16 weeks. EASI measures extent and severity of disease.
Data from ADvocate 1 and ADvocate 2 showed that 80% of patients had EASI-75 that lasted beyond 16 weeks to 1 year; more than 70% maintained this response with no or minimal fluctuations. In addition, patients treated with a 2-week versus 4-week regimen had similar improvements.
ADhere was a 16-week randomized, double-blind, placebo-controlled, parallel-group, global, phase 3 study that evaluated lebrikizumab with topical corticosteroids (TCS). Primary outcomes were a 0 or 1 IGA score with reduction from baseline, along with a 75% change from baseline according to EASI. Lebrikizumab improved skin according to EASI, and it improved it with or without TCS.
Adverse events (AEs) occurred in 58% of patients in ADvocate 1 and ADvocate 2 and in 68% of patients in ADhere. The most common AEs include conjunctivitis, common cold (nasopharyngitis), and headache.
Lebrikizumab is a novel, investigational, monoclonal antibody that binds to, and blocks,interleukin 13 (IL-13), which is responsible for skin barrier disfunction, itch, skin thickening, and susceptibility to infection. The potent IL-13 blocker is expected to receive regulatory decisions later this year.
"These data suggest lebrikizumab may improve the signs and symptoms that many patients with AD experience and are particularly meaningful for those who are in urgent need of new approaches to treating this disease," said Karl Ziegelbauer, PhD, chief scientific officer at Almirall, in the press release.
"We're excited lebrikizumab may be a promising new medicine if approved this year."
Eli Lilly and Company. Up to 73% of Atopic Dermatitis Patients Taking Lilly's Lebrikizumab Had Improved or Cleared Skin on Face or Hands in New Analysis. News Release. May 1, 2023. Accessed on May 2, 2023. https://investor.lilly.com/news-releases/news-release-details/73-atopic-dermatitis-patients-taking-lillys-lebrikizumab-had