Majority of Patients Treated with Lebrikizumab Achieved Skin Clearance in Lilly's Pivotal Phase 3 Atopic Dermatitis Studies
Lebrikizumab rapidly improved skin and itch symptoms in four weeks
"Patients with atopic dermatitis experience persistent itch, dry skin, severe pain and inflammation, which can be unpredictable and affect their work, social relationships, mental and emotional health," said
Lebrikizumab is a 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.6 In AD, IL-13 underlies the signs and symptoms including skin barrier dysfunction, itch, infection and hard, thickened areas of skin.7
In ADvocate 1, 43 percent of patients receiving lebrikizumab achieved clear or almost clear skin (IGA) at 16 weeks compared to 13 percent of patients taking placebo. Among those receiving lebrikizumab, 59 percent achieved an
In ADvocate 2, 33 percent of patients taking lebrikizumab achieved clear or almost clear skin (IGA) at 16 weeks, compared to 11 percent of patients on placebo. Among those receiving lebrikizumab, 51 percent achieved an
Within four weeks, patients receiving lebrikizumab experienced statistically significant improvements in skin clearance and itching, as well as improvements in interference of itch on sleep, and quality of life, as measured by key secondary endpoints.
The safety profile of the 16-week period was consistent with prior lebrikizumab studies in AD. Patients taking lebrikizumab, compared to placebo, reported a lower frequency of adverse events in ADvocate 1 (lebrikizumab: 45%, placebo: 52%) and ADvocate 2 (lebrikizumab: 53%, placebo: 66%). Most adverse events across the two studies were mild or moderate in severity and nonserious and did not lead to treatment discontinuation. The most common adverse events in ADvocate 1 and 2 for those on lebrikizumab were conjunctivitis (7% and 8%, respectively), common cold (nasopharyngitis) (4% and 5%, respectively) and headache (3% and 5%, respectively).
"People's experiences and struggles with autoimmune diseases, such as atopic dermatitis, drive us at
Detailed 52-week results from ADvocate 1 and 2, as well as 16-week data from ADhere, the Phase 3 AD study of lebrikizumab with topical steroids, will be disclosed in coming months.
"Patients need new treatment options that provide high efficacy and tolerability. These positive data demonstrate that lebrikizumab has the potential to be a leading treatment in AD," said
About ADvocate 1 and ADvocate 2 and the Phase 3 Program
ADvocate 1 and ADvocate 2 are ongoing 52-week randomized, double-blind, placebo-controlled, parallel-group, global, Phase 3 studies designed to evaluate lebrikizumab as monotherapy in adult and adolescent patients (aged 12 to less than 18 years of age and weighing at least 40 kg) with moderate-to-severe AD. During the 16-week treatment period, patients received lebrikizumab 500-mg initially and at two weeks, followed by lebrikizumab 250-mg or placebo every two weeks. The primary endpoints were measured by an Investigator Global Assessment (IGA) score of clear (0) or almost clear (1) skin with a reduction of at least two points 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.8 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.9
Moderate-to-severe AD is characterized by intense itching, which leads to an itch-scratch cycle that further damages the skin.10 Like other chronic inflammatory diseases, AD is immune-mediated and involves a complex interplay of immune cells and inflammatory cytokines.8 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.6,7
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 Bieber T. Allergy. 2020;75(1):54-62.
8 Weidinger S, Novak N.
9 Langan SM, et al. Arch Dermatol. 2008;142:1109.
10 Yosipovitch G, et al. Curr Allergy Rep. 2008;8:306-311.
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