Dupixent® (dupilumab) late-breaking data at AAD
show significant improvements in signs and symptoms of
moderate-to-severe atopic hand and foot dermatitis
- More than twice as many patients on
Dupixent achieved clear or almost clear skin compared to placebo at
16 weeks
- Nearly four times as many patients
on Dupixent saw a clinically meaningful reduction of itch, with
improvements seen as early as one week
Paris and
Tarrytown,
N.Y. March
18, 2023. Positive results from
the clinical trial assessing Dupixent® (dupilumab) in adults and
adolescents with uncontrolled moderate-to-severe atopic hand and
foot dermatitis were presented today. The trial, the first
evaluating a biologic for this difficult-to-treat population, met
its primary and key secondary endpoints. The results were featured
in a late-breaking session, one of more than 20 Dupixent scientific
presentations, at the American Academy of Dermatology (AAD) 2023
Annual Meeting.
Eric L. Simpson, M.D.Frances J.
Storrs Professor of Medical Dermatology at the Oregon Health and
Science University and principal investigator of this trial“Atopic
hand and foot dermatitis can extensively disrupt the lives of
patients, given the intense itch and painful skin lesions it causes
on essential body areas. In this trial, Dupixent significantly
improved disease signs, symptoms and quality of life measures for
this particularly difficult-to-treat subset of atopic dermatitis
patients, with itch improvement seen as early as one week after the
first dose. While the efficacy and safety profile of Dupixent is
well-established for atopic dermatitis more broadly, these positive
results are the first demonstrating the impact on specific and
heavily used areas of the body.”
In the trial, patients received Dupixent (n=67)
every two weeks (adults 300 mg, adolescents 200 mg or 300 mg based
on body weight) or placebo (n=66). At 16 weeks, patients treated
with Dupixent experienced the following:
- 40% achieved clear or almost clear
skin on hands and feet compared to 17% with placebo (p≤0.01), the
primary endpoint.
- 52% saw a clinically meaningful
reduction in itch on hands and feet compared to 14% with placebo
(p<0.0001), the key secondary endpoint.
- 69% average reduction in signs of
hand and foot lesions from baseline compared to 31% with placebo
(p<0.0001).
- 75% average improvement in hand
eczema disease severity from baseline compared to 40% with placebo
(p<0.0001).
- There were significant improvements
in measures of hand and foot skin pain, sleep and hand
eczema-related quality of life.
The trial demonstrated similar safety results to
the known safety profile of Dupixent in atopic dermatitis. Overall
rates of adverse events (AEs) were 66% for Dupixent and 74% for
placebo. AEs more commonly observed with Dupixent (≥5%) compared to
placebo included nasopharyngitis (16% Dupixent, 11% placebo), upper
respiratory tract infection (9% Dupixent, 5% placebo),
conjunctivitis (6% Dupixent, 2% placebo), herpes viral infections
(6% Dupixent, 3% placebo) and increased blood creatine
phosphokinase (6% Dupixent, 0% placebo). Additionally, 3% of
patients taking Dupixent used at least one rescue medication
compared to 21% of patients on placebo.
There are 23 Dupixent scientific abstracts being
presented across three dermatological diseases with underlying type
2 inflammation at the AAD 2023 Annual Meeting. These include oral
presentations on long-term Dupixent use in children as young as 6
months with atopic dermatitis; the impact of Dupixent treatment on
health-related quality of life, skin pain and sleep in prurigo
nodularis; and the investigational use of Dupixent on signs,
symptoms and health-related quality of life in chronic spontaneous
urticaria.
The potential use of Dupixent in chronic
spontaneous urticaria is currently under clinical development, and
the safety and efficacy have not been fully evaluated by any
regulatory authority.
About the Dupixent Trial
The Phase 3 double-blind, placebo-controlled
trial evaluated the efficacy and safety of Dupixent in 133
adolescents and adults with moderate-to-severe atopic hand and foot
dermatitis who had an inadequate response or intolerance to topical
corticosteroids. Patients with hand and foot disease predominantly
driven by allergic or irritant contact dermatitis were excluded
from the trial.
The primary endpoint evaluated the proportion of
patients with clear or almost clear skin of hand and feet eczema at
16 weeks (measured by a score of 0 or 1 on the Investigator Global
Assessment Scale). The key secondary endpoint measured the
proportion of patients with improvement in itch on hands and feet
from baseline (measured by a ≥4-point reduction in Peak-Pruritis
Numeric Rating Scale [PP-NRS] on a 0-10 scale) at 16 weeks. Lesion
sign reduction was assessed by change from baseline in Modified
Total Lesion Sign Score (mTLSS; measured by a 0-36 scale), and
disease severity was assessed by the change from baseline in Hand
Eczema Severity Index (HECSI) score (measured by a 0-360 scale).
Symptoms were assessed every one or two weeks during the trial.
Additional secondary endpoints included:
- Skin pain reduction as assessed by
the change from baseline in weekly average of daily hand and foot
peak pain NRS (measured by a 0-10 scale).
- Sleep improvement as assessed by
change from baseline in weekly average of daily Sleep NRS (measured
by a 0-10 scale).
- Health-related quality of life,
assessed by change from baseline in the Quality of Life in Hand
Eczema Questionnaire (QoLHEQ) (measured by a 0-117 scale).
About Dupixent
Dupixent is a fully human monoclonal antibody
that inhibits the signaling of the interleukin-4 (IL-4) and
interleukin-13 (IL-13) pathways and is not an immunosuppressant.
The Dupixent development program has shown significant clinical
benefit and a decrease in type 2 inflammation in Phase 3 trials,
establishing that IL-4 and IL-13 are key and central drivers of the
type 2 inflammation that plays a major role in multiple related and
often co-morbid diseases. These diseases include approved
indications for Dupixent, such as atopic dermatitis, asthma,
chronic rhinosinusitis with nasal polyposis (CRSwNP), eosinophilic
esophagitis (EoE) and prurigo nodularis.
Dupixent has received regulatory approvals in
one or more countries around the world for use in certain patients
with atopic dermatitis, asthma, CRSwNP, EoE or prurigo nodularis in
different age populations. Dupixent is currently approved for one
or more of these indications in more than 60 countries, including
in the U.S., European Union and Japan. More than 600,000 patients
are being treated with Dupixent globally.
Dupilumab Development
Program
Dupilumab is being jointly developed by Sanofi
and Regeneron under a global collaboration agreement. To date,
dupilumab has been studied across more than 60 clinical trials
involving more than 10,000 patients with various chronic diseases
driven in part by type 2 inflammation.
In addition to the currently approved
indications, Sanofi and Regeneron are studying dupilumab in a broad
range of diseases driven by type 2 inflammation or other allergic
processes in Phase 3 trials, including pediatric EoE, chronic
inducible urticaria-cold, chronic spontaneous urticaria, chronic
pruritus of unknown origin, chronic obstructive pulmonary disease
with evidence of type 2 inflammation, chronic rhinosinusitis
without nasal polyposis, allergic fungal rhinosinusitis, allergic
bronchopulmonary aspergillosis and bullous pemphigoid. These
potential uses of dupilumab are currently under clinical
investigation, and the safety and efficacy in these conditions have
not been fully evaluated by any regulatory authority.
About Regeneron
Regeneron (NASDAQ: REGN) is a leading
biotechnology company that invents, develops and commercializes
life-transforming medicines for people with serious diseases.
Founded and led for 35 years by physician-scientists, our unique
ability to repeatedly and consistently translate science into
medicine has led to nine FDA-approved treatments and numerous
product candidates in development, almost all of which were
homegrown in our laboratories. Our medicines and pipeline are
designed to help patients with eye diseases, allergic and
inflammatory diseases, cancer, cardiovascular and metabolic
diseases, pain, hematologic conditions, infectious diseases and
rare diseases.
Regeneron is accelerating and improving the
traditional drug development process through our proprietary
VelociSuite® technologies, such as VelocImmune®, which uses unique
genetically humanized mice to produce optimized fully human
antibodies and bispecific antibodies, and through ambitious
research initiatives such as the Regeneron Genetics Center, which
is conducting one of the largest genetics sequencing efforts in the
world.
For more information, please visit
www.Regeneron.com or follow @Regeneron on Twitter.
About SanofiWe are an innovative global
healthcare company, driven by one purpose: we chase the miracles of
science to improve people’s lives. Our team, across some 100
countries, is dedicated to transforming the practice of medicine by
working to turn the impossible into the possible. We provide
potentially life-changing treatment options and life-saving vaccine
protection to millions of people globally, while putting
sustainability and social responsibility at the center of our
ambitions.
Sanofi is listed on EURONEXT: SAN and NASDAQ:
SNY.
Media RelationsSally
Bain | + 1 617 834 6026
| sally.bain@sanofi.com
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Schaefer-Jansen | + 33 7 86 80 56 39
| eva.schaefer-jansen@sanofi.comArnaud
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