Positive topline results were announced from two phase 3 studies evaluating the efficacy and safety of lebrikizumab as monotherapy for the treatment of patients with moderate to severe atopic dermatitis.
Lebrikizumab is a novel humanized monoclonal antibody that selectively inhibits interleukin-13 (IL-13), specifically preventing the formation of the IL-13Rα1/IL-4Rα heterodimer complex and subsequent signaling. IL-13 is believed to play a central role in atopic dermatitis.
The ongoing 52-week randomized, double-blind, placebo-controlled ADvocate 1 (ClinicalTrials.gov Identifier: NCT04146363) and ADvocate 2 (ClinicalTrials.gov Identifier: NCT04178967) studies included patients aged 12 years and older weighing at least 40kg with moderate to severe atopic dermatitis. Patients were randomly assigned to receive placebo or lebrikizumab subcutaneously (SC) for a 16-week induction period followed by a 36-week maintenance period.
The primary endpoints were the proportion of patients achieving an Investigator’s Global Assessment Treatment Success (IGA-TS) score of 0 (clear) or 1 (almost clear) with a reduction of at least 2 points from baseline at week 16, and the proportion of patients with greater than or equal to 75% improvement from baseline in the Eczema Area and Severity Index (EASI 75) score at week 16.
Findings showed that both studies met the primary endpoints, with more than 50% of lebrikizumab-treated patients achieving EASI 75 at week 16. Key secondary endpoints (Pruritus Numerical Rating Scale (NRS) score, Sleep-Loss due to Pruritus score, Dermatology Life Quality Index) were also met at week 16.
“Data from the studies showed lebrikizumab’s effect on skin clearance and its potential to address a key driver for this disease as well as provide improvements in itch, sleep disturbance and quality of life,” said Jonathan Silverberg, MD, PhD, MPH, associate professor of dermatology at George Washington University School of Medicine and Health Sciences in Washington, DC, and a principal investigator of the ADvocate 2 trial.
The most common adverse events reported with lebrikizumab included conjunctivitis, nasopharyngitis and headache. Full data from both studies will be available at future medical congresses in 2022.
The FDA previously granted Fast Track designation to lebrikizumab for atopic dermatitis.
The Company is also evaluating the efficacy and safety of lebrikizumab in combination with topical corticosteroids in the phase 3 ADhere study (ClinicalTrials.gov Identifier: NCT04250337) for the treatment of patients with moderate to severe atopic dermatitis. Data from the ADhere study will be available later this year.
Lilly’s lebrikizumab significantly improved skin clearance and itch in people with moderate-to-severe atopic dermatitis in two Phase 3 trials. News release. Eli Lilly and Company. Accessed August 16, 2021. https://www.prnewswire.com/news-releases/lillys-lebrikizumab-significantly-improved-skin-clearance-and-itch-in-people-with-moderate-to-severe-atopic-dermatitis-in-two-phase-3-trials-301355459.html.