Eight out of Ten Patients Maintained Skin Clearance at One Year in Lilly's Lebrikizumab Atopic Dermatitis Monotherapy Trials
80% of lebrikizumab responders maintained improvements in skin clearance and disease severity at 52 weeks; lasting improvements in itch were also observed
Data supported both once every two week and once every four week maintenance dosing, with consistent and durable responses
"Atopic dermatitis is a complex disease that requires personalized treatment approaches, including flexible dosing options for patients. In these studies, patients treated with lebrikizumab maintained skin clearance and lasting relief from intense itch at one year. We believe this supports the potential of lebrikizumab to become a first-line biologic and may support less frequent dosing," said Lotus Mallbris, M.D., Ph.D., vice president of global immunology development and medical affairs at
AD, or atopic eczema, is a chronic, relapsing, heterogenous skin disease characterized by intense itching, dry skin and inflammation that can be present on any part of the body.1-2 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.3-7 IL-13 plays the central role in AD, promoting Type 2 inflammation that drives skin barrier dysfunction, itch, skin thickening and infection.8-10
In ADvocate 1, 79% of patients who received lebrikizumab every four weeks and 79% of patients who received lebrikizumab every two weeks maintained 75% or greater skin improvement (
The frequency of adverse events and the overall safety profile among these patients treated with lebrikizumab were consistent with the induction phase of the trials as well as previous lebrikizumab studies in AD. No new safety signals were observed in this patient population.
"ADvocate 1 and 2 results add to the exciting growing body of evidence from our Phase 3 clinical trial program and demonstrate that this medicine may provide much-needed relief for those seeking new treatment options. We look forward to continuing our collaboration with
With these data,
These studies are part of the comprehensive clinical development program for lebrikizumab in AD evaluating more than 2,000 patients. Full one-year results from the Phase 3 monotherapy studies will be disclosed at upcoming congresses and in publications in 2022. Additional Phase 3 clinical trials are enrolling for lebrikizumab in AD.
About ADvocate 1 and ADvocate 2 and the Phase 3 Program
ADvocate 1 and ADvocate 2 are 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. In the maintenance period, patients with moderate-to-severe AD who achieved a clinical response after 16 weeks of lebrikizumab treatment were re-randomized to receive lebrikizumab every two weeks or four weeks or placebo for an additional 36 weeks. Patients who required rescue treatment during the induction period or who did not achieve clinical response (lebrikizumab non-responders) at 16 weeks received lebrikizumab every two weeks for an additional 36 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 (
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
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2 Langan SM, et al. Arch Dermatol. 2008;142:1109.
3 Moyle M, et al. Exp Dermatol. 2019;28(7):756-768.
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6 Simpson EL, et al. J Am Acad Dermatol. 2018;78(5):863-871.e11.
7 Okragly A, et al. Comparison of the Affinity and in vitro Activity of Lebrikizumab, Tralokinumab, and Cendakimab. Presented at the Inflammatory Skin Disease
8 Tsoi L, et al.
9 Ratnarajah K, et al.
10 Bieber T. Allergy. 2020;75(1):54-62.
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