Patients with moderate to severe atopic dermatitis treated with lebrikizumab maintained improvements in skin clearance at 1 year of treatment, according to long-term findings from two phase 3 trials.
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 52-week randomized, double-blind, placebo-controlled ADvocate 1 (ClinicalTrials.gov Identifier: NCT04146363) and ADvocate 2 (ClinicalTrials.gov Identifier: NCT04178967) trials evaluated the efficacy and safety of lebrikizumab as monotherapy for the treatment of patients aged 12 years and older weighing at least 40kg with moderate to severe atopic dermatitis.
In the induction period, patients were randomly assigned to receive placebo or lebrikizumab subcutaneously (SC) every 2 weeks for 16 weeks. In the maintenance period, patients who achieved a clinical response were randomly assigned again to receive placebo or lebrikizumab SC every 2 or 4 weeks for an additional 36 weeks.
The primary endpoints were the proportion of patients achieving an Investigator Global Assessment (IGA) 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 at least 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. Results from 52-week analyses demonstrated that 80% of lebrikizumab responders maintained improvements in skin clearance and disease severity.
In ADvocate 1, 79% of patients treated with lebrikizumab every 4 weeks and 79% of patients treated with lebrikizumab every 2 weeks maintained EASI 75 response at 1 year of treatment. In ADvocate 2, 85% of patients treated with lebrikizumab every 4 weeks and 77% of patients treated with lebrikizumab every 2 weeks maintained EASI 75 response at 1 year of treatment.
“In these studies, patients treated with lebrikizumab maintained skin clearance and lasting relief from intense itch at 1 year,” said Lotus Mallbris, MD, PhD, vice president of global immunology development and medical affairs at Lilly. “We believe this supports the potential of lebrikizumab to become a first-line biologic and may support less frequent dosing.”
The Company plans to submit a Biologics License Application to the Food and Drug Administration for lebrikizumab in atopic dermatitis in the second half of 2022.
Eight out of ten patients maintained skin clearance at one year in Lilly’s lebrikizumab atopic dermatitis monotherapy trials. News release. Eli Lilly and Company. Accessed June 7, 2022. https://www.prnewswire.com/news-releases/eight-out-of-ten-patients-maintained-skin-clearance-at-one-year-in-lillys-lebrikizumab-atopic-dermatitis-monotherapy-trials-301562237.html
This article originally appeared on MPR
Brian Park, PharmD