Lilly's Lebrikizumab Combined with Topical Corticosteroids Showed Significant Improvements in Disease Severity for Atopic Dermatitis
Lebrikizumab significantly improved several areas of great importance to patients with atopic dermatitis, including
skin and itch, in pivotal combination trial that met all primary and key secondary endpoints
"Today's ADhere data, together with results from the ADvocate monotherapy studies, demonstrate the potential for lebrikizumab to reduce disease burden and provide relief for people with uncontrolled atopic dermatitis when used either alone or combined with topicals," said Eric Simpson, M.D., M.C.R., Professor of Dermatology and Director of Clinical Research at
Lebrikizumab is a novel, monoclonal antibody (mAb) that binds to the interleukin 13 (IL-13) protein with high affinity to specifically prevent the formation of IL-13Rα1/IL-4Rα (Type 2 receptor) which blocks downstream signaling through the IL-13 pathway.1-5 IL-13 plays the central role in Type 2 inflammation in AD.6,7 In AD, IL-13 underlies the signs and symptoms including skin barrier dysfunction, itch, infection and hard, thickened areas of skin.8
Among patients taking lebrikizumab plus TCS, 41 percent achieved clear or almost clear skin (IGA) at 16 weeks compared to 22 percent of patients taking placebo plus TCS. At 16 weeks, 70 percent of patients taking lebrikizumab plus TCS achieved an
Patients treated with lebrikizumab plus TCS also achieved statistically significant improvements across key secondary endpoints including skin clearance and itching, interference of itch on sleep, and quality of life measures, compared to placebo with TCS. Clinically meaningful differences were observed as early as four weeks for itch, interference of itch on sleep, and quality of life measures.
Safety results were consistent with prior lebrikizumab studies in AD. Patients taking lebrikizumab plus TCS, compared to placebo plus TCS, reported a higher frequency of adverse events (lebrikizumab plus TCS: 43%, placebo plus TCS: 35%). Most adverse events were mild or moderate in severity and nonserious and did not lead to treatment discontinuation. The most common adverse events for those on lebrikizumab were conjunctivitis (5%) and headache (5%).
"These results are a further step in our commitment to deliver innovative therapies that make a meaningful difference to patients. We look forward to announcing exciting new milestones in the months to come," commented
About ADhere and the Phase 3 Program
ADhere is a 16-week randomized, double-blind, placebo-controlled, parallel-group, global, Phase 3 study to evaluate the efficacy and safety of lebrikizumab in combination with TCS initiated in 211 adult and adolescent patients (aged 12 to less than 18 years of age and weighing at least 40 kg) with moderate-to-severe AD. In the study, patients' AD symptoms were inadequately controlled by TCS with or without topical calcineurin inhibitors (TCI). The study was designed to be more reflective of clinical practice and patients were provided with mid-potency TCS (triamcinolone acetonide 0.1% cream), and low-potency TCS (hydrocortisone 1% cream, for use on sensitive skin areas) which could be tapered, stopped or resumed at the patient's discretion.
The primary endpoints were measured by an Investigator Global Assessment (IGA) score of clear (0) or almost clear (1) skin with a reduction from baseline and at least 75 percent change in baseline in the Eczema Area and Severity Index (
About Atopic Dermatitis
Atopic dermatitis (AD), or atopic eczema, is a chronic, relapsing skin disease characterized by intense itching, dry skin and inflammation that can be present on any part of the body.9 AD is a heterogeneous disease both biologically and clinically, and may be characterized by a highly variable appearance in which flares occur in an unpredictable manner.10
Moderate-to-severe AD is characterized by intense itching, which leads to an itch-scratch cycle that further damages the skin.11 Like other chronic inflammatory diseases, AD is immune-mediated and involves a complex interplay of immune cells and inflammatory cytokines.9 People living with AD often report symptoms of intense, persistent itch which can be so uncomfortable that it can affect sleep, daily activities and social relationships.
Lebrikizumab is a novel, investigational, monoclonal antibody designed to bind IL-13 with high affinity to specifically prevent the formation of the IL-13Rα1/IL-4Rα heterodimer complex and subsequent signaling, thereby inhibiting the biological effects of IL-13 in a targeted and efficient fashion. IL-13 is the central pathogenic mediator of AD, promoting type 2 inflammation that drives skin barrier dysfunction, itch, skin thickening and infection.6-8
Lilly Cautionary Statement Regarding Forward-Looking Statements
This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about lebrikizumab as a potential treatment for patients with atopic dermatitis and reflects
1 Moyle M, et al. Exp Dermatol. 2019;28(7):756-768.
2 Ultsch M, et al. J Mol Biol. 2013;425(8):1330-1339.
3 Zhu R, et al. Pulm Pharmacol Ther. 2017;46:88-98.
4 Simpson EL, et al. J Am Acad Dermatol. 2018;78(5):863-871.e11.
5 Okragly A, et al. Comparison of the Affinity and in vitro Activity of Lebrikizumab, Tralokinumab, and Cendakimab. Presented at the Inflammatory Skin Disease
6 Tsoi L, et al.
7 Ratnarajah K, et al.
8 Bieber T. Allergy. 2020;75(1):54-62.
9 Weidinger S, Novak N.
10 Langan SM, et al. Arch Dermatol. 2008;142:1109.
11 Yosipovitch G, et al. Curr Allergy Rep. 2008;8:306-311.
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