Treatment with lebrikizumab plus topical corticosteroids (TCS) was associated with significant skin improvement in patients with moderate to severe atopic dermatitis, according to data from the phase 3 ADhere trial.
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 randomized, double-blind, placebo-controlled ADhere trial (ClinicalTrials.gov Identifier: NCT04250337) evaluated the efficacy and safety of lebrikizumab in combination with TCS in adults and adolescents with moderate to severe atopic dermatitis. Patients were randomly assigned to receive placebo or lebrikizumab subcutaneously for 16 weeks.
Findings showed that a greater proportion of patients treated with lebrikizumab plus TCS achieved Investigator’s Global Assessment (IGA) score of 0 (clear) or 1 (almost clear) with a reduction of at least 2 points from baseline, and at least a 75% improvement from baseline in the Eczema Area and Severity Index (EASI 75) score, compared with placebo. Moreover, lebrikizumab was associated with greater itch relief and other quality of life measures. The most common adverse reactions reported were conjunctivitis and headache.
“I’m encouraged by the aggregate efficacy and safety data which have demonstrated the potential for lebrikizumab as both monotherapy and combination therapy to address unmet needs and improve care for people living with persistent itch and inflamed skin caused by AD,” said Eric Simpson, MD, MCR, Professor of Dermatology and Director of Clinical Research at Oregon Health & Science University in Portland and a principal investigator of the ADhere study.
Lilly previously announced topline results from two phase 3 trials (ADvocate 1 [ClinicalTrials.gov Identifier: NCT04146363] and ADvocate 2 [ClinicalTrials.gov Identifier: NCT04178967]), which evaluated lebrikizumab as monotherapy for moderate to severe atopic dermatitis.
Lilly’s lebrikizumab demonstrated significant skin improvement and itch relief when combined with topical corticosteroids in people with atopic dermatitis in third Phase 3 study. News release. Eli Lilly and Company. Accessed December 21, 2021. https://www.prnewswire.com/news-releases/lillys-lebrikizumab-demonstrated-significant-skin-improvement-and-itch-relief-when-combined-with-topical-corticosteroids-in-people-with-atopic-dermatitis-in-third-phase-3-study-301448625.html.