INDIANAPOLIS, March 10,
2024 /PRNewswire/ -- Eli Lilly and Company
(NYSE: LLY) announced results from a first-of-its-kind study of
lebrikizumab specifically designed for people with skin of color
and moderate-to-severe atopic dermatitis, commonly called eczema.
In this study, treatment with lebrikizumab, an investigational
medicine, showed improvement in skin clearance and itch
relief. These late-breaking results from a Phase 3 study are being
presented today at the American Academy of Dermatology (AAD) Annual
Meeting.
The lebrikizumab efficacy results from this trial are consistent
with data in other Phase 3 studies, which further reinforces
lebrikizumab's potential to be a first-line biologic treatment
following topical prescription therapies for people across a range
of skin tones with moderate-to-severe atopic dermatitis.
"People with skin of color are disproportionately affected by
atopic dermatitis, often experiencing more severe symptoms, a delay
in diagnosis and a lengthier timeframe to find appropriate
treatment. They also have been historically underrepresented in
clinical trials, which means we have lacked data pertaining to the
treatment of patients with skin of color," said Andrew Alexis, M.D., M.P.H., Professor of
Clinical Dermatology and Vice Chair for Diversity and Inclusion in
the Department of Dermatology at Weill Cornell Medicine, a
dermatologist at New York-Presbyterian/Weill Cornell Medical
Center, and lead study investigator. "With these initial results,
Lilly is taking a step toward investigating the needs of people
with skin of color affected by atopic dermatitis."
The initial 16-week data from this study evaluated 50 patients
with moderate-to-severe atopic dermatitis and darker skin tones as
measured by the Fitzpatrick scale, including people who
self-identify as Black or African American (80%), Asian (14%),
American Indian or Alaska Native (6%). Of the 50 patients, 11 also
self-identified as Hispanic/Latinx (22%) with the remaining 39
self-identifying as non-Hispanic/Latinx (78%). All patients
received lebrikizumab 500-mg subcutaneously initially and at two
weeks followed by 250-mg subcutaneously every two weeks to Week 16.
Results at 16 weeks were consistent with the 16-week results from
the ADhere and ADvocate 1 & 2 studies.
- 68% of people experienced significant improvement of at least
75% in disease extent and severity
(EASI-75)*.
- 46% of people experienced at least 90% improvement in disease
extent and severity (EASI-90)†.
- 39% of people achieved clear or almost clear skin (IGA
0,1)‡ with a reduction of at least two points from
baseline.
- 55% of people experienced clinically meaningful
itch relief (PNRS ≥4-point
improvement)§.
No new safety signals were observed and there were no serious
adverse events reported. The study also included a physician
assessment of changes in post-inflammatory pigmentation using the
newly developed PDCA-Derm™ scale. Full efficacy and safety
results from the study will be shared at future congresses.
"Lebrikizumab is the first investigative treatment for atopic
dermatitis to disclose robust efficacy data specifically for people
with skin of color, who may experience barriers to treatment or
inequitable care," said Mark
Genovese, M.D., senior vice president of Immunology
Development at Lilly. "Through clinical trials like this, we hope
to deliver more breakthroughs to make life better for people who
have been underserved."
Lilly is committed to finding solutions to elevate care and
improve treatment outcomes for all people living with dermatologic
conditions, including addressing the unmet needs of people with
skin of color. The company's work to advance health equity in
dermatology is focused on engaging in impactful research that
improves patient care, supporting health care providers with
education to increase awareness of dermatologic diseases in
patients with skin of color, and empowering the patient voice so
patients can make their needs known and actively partner to find
meaningful solutions.
Specific to clinical research, Lilly continues to engage in
efforts to involve a more diverse range of participants in clinical
trials and establish clear, measurable goals to drive progress.
Lilly has exclusive rights for development and commercialization
of lebrikizumab in the U.S. and the rest of the world
outside Europe. Lilly's partner Almirall S.A. has licensed the
rights to develop and commercialize lebrikizumab for the treatment
of dermatology indications, including eczema, in Europe.
*EASI=Eczema Area and Severity Index, EASI-75=75 percent
reduction in EASI from baseline to Week 16
† Eczema Area and Severity Index ≥ 90 percent Reduction
‡ IGA=Investigator's Global Assessment 0 or 1 ("clear" or
"almost clear")
§ PNRS=Pruritus Numeric Rating Scale in participants with a
baseline PNRS of ≥ 4
Fitzpatrick phototype describes the amount of melanin pigment in
the skin by determining constitutional color and the effect of
exposure to ultraviolet radiation and "darker skin tone" is defined
as IV-VI on the scale
About
ADmirable
ADmirable (NCT05372419)1 is a
Phase 3b, open-label, 24-week
study, evaluating the safety and efficacy of lebrikizumab in adult
and adolescent patients with skin of color and
moderate-to-severe atopic dermatitis and defining innovative
objective measures of pigment, erythema, and post-inflammatory
hyper and hypopigmentation. Patients enrolled in the ADmirable
study received lebrikizumab 500-mg subcutaneously initially and at
two weeks followed by 250-mg every two weeks until Week
16.2 These interim data, which were analyzed before the
completion of the 24-week study, represent primary and secondary
endpoints from the study at 16 weeks.
About Lebrikizumab and Clinical Development
Program
Lebrikizumab is an investigational, monoclonal
antibody that targets IL-13 with high binding affinity and slow
dissociation rate, to specifically prevent the formation of the
IL-13Rα1/IL-4Rα heterodimer complex and subsequent signaling,
thereby inhibiting the biological effects of IL-13.3-5
The cytokine IL-13 is key in atopic dermatitis, driving the type-2
inflammatory loop in the skin, leading to skin barrier dysfunction,
itch, skin thickening and infection.6,7
The lebrikizumab Phase 3 program consists of five key global
studies evaluating over 1,300 patients, including two monotherapy
studies (ADvocate 1 and 2), a combination study with topical
corticosteroids (ADhere), as well as long-term extension (ADjoin)
and adolescent open label (ADore) studies. Further data
results from a study dedicated to people with skin of color
(ADmirable) and patients previously treated with dupilumab (ADapt)
are expected to be shared in late 2024.
About Lilly
Lilly is a medicine company turning
science into healing to make life better for people around the
world. We've been pioneering life-changing discoveries for nearly
150 years, and today our medicines help more than 51 million people
across the globe. Harnessing the power of biotechnology, chemistry
and genetic medicine, our scientists are urgently advancing new
discoveries to solve some of the world's most significant health
challenges: redefining diabetes care; treating obesity and
curtailing its most devastating long-term effects; advancing the
fight against Alzheimer's disease; providing solutions to some of
the most debilitating immune system disorders; and transforming the
most difficult-to-treat cancers into manageable diseases. With each
step toward a healthier world, we're motivated by one thing: making
life better for millions more people. That includes delivering
innovative clinical trials that reflect the diversity of our world
and working to ensure our medicines are accessible and affordable.
To learn more, visit Lilly.com and Lilly.com/news, or follow
us on Facebook, Instagram and LinkedIn.
*Disclosure: Dr. Andrew Alexis is
a paid advisory member and speaker for Eli Lilly and Company. He
has not been compensated for any media work.
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 treatment
for people with moderate-to-severe atopic dermatitis and reflects
Lilly's current beliefs and expectations. However, as with any
pharmaceutical product, there are substantial risks and
uncertainties in the process of drug research, development, and
commercialization. Among other things, there is no guarantee that
planned or ongoing studies will be completed as planned, that
future study results will be consistent with study results to date,
or that lebrikizumab will receive additional regulatory approvals,
or be commercially successful. For further discussion of these and
other risks and uncertainties that could cause actual results to
differ from Lilly's expectations, see Lilly's Form 10-K and Form
10-Q filings with the United States Securities and Exchange
Commission. Except as required by law, Lilly undertakes no duty to
update forward-looking statements to reflect events after the date
of this release.
1 Alexis A, et al. presented at Maui Derm
2024.
2 Alexis A, et al. Efficacy and safety of lebrikizumab
in adult and adolescent patients with skin of color and
moderate-to-severe atopic dermatitis: an interim analysis of the
open-label phase 3b trial, ADmirable.
2024 American Academy of Dermatology Conference. March 10, 2024.
3 Simpson EL, et al. Efficacy and safety of lebrikizumab
(an anti-IL-13 monoclonal antibody) in adults with
moderate-to-severe atopic dermatitis inadequately controlled by
topical corticosteroids: A randomized, placebo-controlled phase II
trial (TREBLE). J Am Acad Dermatol. 2018;78(5):863-871.e11.
doi:10.1016/j.jaad.2018.01.017
4 Okragly A, et al. Binding, Neutralization and
Internalization of the Interleukin-13 Antibody, Lebrikizumab.
Dermatol Ther (Heidelb). 2023;13(7):1535-1547.
doi:10.1007/s13555-023-00947-7
5 Ultsch M, et al. Structural basis of signaling
blockade by anti-IL-13 antibody Lebrikizumab. J Mol Biol.
2013;425(8):1330-1339. doi:10.1016/j.jmb.2013.01.024
6 Bieber T. Interleukin-13: Targeting an
underestimated cytokine in atopic dermatitis. Allergy.
2020;75(1):54–62. doi:10.1111/all.13954
7 Tsoi LC, et al. Atopic Dermatitis Is an
IL-13-Dominant Disease with Greater Molecular Heterogeneity
Compared to Psoriasis. J Invest Dermatol. 2019;139(7):1480-1489.
doi:10.1016/j.jid.2018.12.018
© Lilly USA, LLC 2024. All rights reserved.
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