New Dupixent® (dupilumab) data in patients as young as 6 years old
with moderate-to-severe atopic dermatitis to be presented at WCPD
and EADV
New Dupixent®
(dupilumab) data in patients as young as 6
years old with
moderate-to-severe
atopic dermatitis to be presented at WCPD
and EADV
- More than 30 presentations reinforce the role of Dupixent in
targeting IL-4 and IL-13, key drivers of the type 2 inflammation
underlying atopic dermatitis in children, adolescents, and
adults
- Results provide insight into the clinical and real-world
experience of Dupixent on key disease measures including itch,
disease severity, sleep and anxiety
- Dupixent presentations include longest duration of data for any
biologic medicine in adults with moderate-to-severe atopic
dermatitis, with results up to 3.5 years
PARIS and TARRYTOWN, N.Y.
– September
21,
2021 - New Dupixent® (dupilumab) analyses
in patients as young as 6 years old with moderate-to-severe atopic
dermatitis will be presented at the 14th World Congress of
Pediatric Dermatology Annual Congress (WCPD) from September 22-25
and the 30th European Academy of Dermatology and Venereology
Congress (EADV) from September 29-October 2.
“The extensive portfolio of Dupixent data being
showcased at these global congresses addresses the impact of
Dupixent on the signs, symptoms and quality of life in patients as
young as six years old with moderate-to-severe atopic dermatitis
and reinforces the need for studying the long-term safety and
efficacy of treatments targeting type 2 inflammation,” said Naimish
Patel, M.D. Head of Global Development in Immunology and
Inflammation at Sanofi. “In addition, we look forward to presenting
key findings from our global Atopic Dermatitis-GAP survey and
Quality of Care Report, which demonstrate our commitment to disease
education and fostering new conversations about best practices for
patient care within the atopic dermatitis community”
Notable Dupixent presentations include long-term
efficacy and safety data showing the impact of Dupixent on signs
and symptoms of moderate-to-severe atopic dermatitis in children,
adolescents and adults. More than 30 presentations include Dupixent
results on skin lesions, itch and skin infections as well as sleep
and health-related quality of life for patients and their families,
including in adults with a history of mental health disorders and
in children with anxiety and depression. Real-world evidence will
be also presented from observational registries and claims
databases across multiple geographies.
Notable disease burden data to be presented at
EADV include results from the Atopic Dermatitis Global Adolescent
and Pediatric Survey on how patients, caregivers, and physicians
view the full impact of moderate-to-severe atopic dermatitis based
on findings from more than 3,900 people across 13 countries. Data
will also be shared from the Quality of Care in AD Initiative,
which documents best practices from 32 atopic dermatitis centers
across the world, focused on the value of patient education and
communication.
Data to be presented at WCPD 2021
Clinical Efficacy and Safety of Dupixent in Atopic
Dermatitis
- Oral presentation (September 24, 3:40-3:50 pm BST):
- #SP42 Long-Term Efficacy and Safety Data for Dupilumab in a
Phase 3, Open-Label Extension Trial (LIBERTY AD PED-OLE) in
Patients Aged ≥ 6 to < 12 Years With Uncontrolled,
Moderate-to-Severe Atopic Dermatitis (AD), Michael Cork
- Poster #P22: Efficacy and Safety of Dupilumab for up to 1 Year
in a Phase 3 Open-Label Extension Trial (LIBERTY AD PED-OLE) in
Adolescents With Uncontrolled, Moderate-to-Severe Atopic Dermatitis
(AD), Andrew Blauvelt
- Poster #P23: 52-Week Laboratory Safety Findings From an
Open-Label Extension (OLE) Study of Dupilumab in Adolescent
Patients With Atopic Dermatitis (LIBERTY AD PED-OLE), Michael
Cork
- Poster #P33: Dupilumab Improved Itch in Children Aged 6–11
Years With Severe Atopic Dermatitis: Analysis From the LIBERTY AD
PEDS Trial, Gil Yosipovitch
- Poster #P35: IGAxBSA: An Alternative to EASI in Assessing
Disease Severity and Response in Pediatric Patients With
Moderate-to-Severe Atopic Dermatitis, Amy Paller
- Poster #P36: Dupilumab Induces Rapid and Sustained Improvement
in Clinical Signs in Children With Severe Atopic Dermatitis, Amy
Paller
- Poster #P38: Dupilumab Significantly Improves All POEM
Components in Children Aged ≥6 to <12 Years With Severe Atopic
Dermatitis, Andreas Wollenberg
- Poster #P40: Efficacy and Safety of Dupilumab in Children Aged
≥ 6 to < 18 Years With a History of Infection (LIBERTY AD PEDS,
LIBERTY AD ADOL), Michael Cork
- Poster #P41: Dupilumab in Children Aged ≥6 to <12 Years
Significantly Improves Global Clinical Signs of Atopic Dermatitis
(LIBERTY AD PEDS), Amy Paller
- Poster #P44: Dupilumab in Children Aged ≥6–<12 Years
Significantly Improves Signs and Symptoms of Atopic Dermatitis
Assessed by SCORAD, Sébastien Barbarot
Quality of Life Data in Atopic Dermatitis for
Dupixent
- Poster #P30: Dupilumab Induces Clinically Meaningful
Improvement in Symptoms of Anxiety and Depression in Children With
Severe Atopic Dermatitis, Elaine Siegfried
- Poster #P37: Dupilumab Treatment Improves Sleep in Children
Aged ≥ 6 to < 12 Years With Severe Atopic Dermatitis, Danielle
Marcoux
- Poster #P46: Dupilumab Improves Family Quality of Life in
Children Aged 6–11 Years With Severe Atopic Dermatitis (LIBERTY AD
PEDS), Amy Paller
Dupixent Use and Vaccination
- Poster #P120: Dupilumab and Live-Attenuated Vaccines:
Experience With Prior Dupilumab Use and Yellow Fever Vaccine in
Patients With Severe Asthma From Brazil, Michael Wechsler
Abstracts presenting
research on the burden of atopic dermatitis include:
- Poster #P29: Children With Atopic Dermatitis (AD) Have a High
Burden of Atopic Comorbidities: Results From a Large Worldwide
Survey, Jonathan Silverberg
Data to be presented at EADV 2021
Long-Term Efficacy and Safety of Dupixent in Atopic
Dermatitis
- Oral Presentation (September 30, 10:00-11:00 am CEST):
- #2008 Long-Term Efficacy of Dupilumab in Adults With
Moderate-to-Severe Atopic Dermatitis: Results From an Open-Label
Extension Trial up to 172 Weeks, Lisa Beck
- Poster #P0258: Dupilumab Provides Long-Term Improvement in
Pruritus in Children With Severe Atopic Dermatitis, and Adolescents
and Adults With Moderate-to-Severe Atopic Dermatitis, Amy
Paller
- Poster #P0723: Patient Well-Being and Perception of Treatment
Effect With Long-Term Dupilumab Monotherapy in Adults With
Moderate-to-Severe Atopic Dermatitis, Eric Simpson
- Poster #P0726: Safety of Long-Term Dupilumab Treatment in
Adults With Moderate-to-Severe Atopic Dermatitis: Results From an
Open-Label Extension Trial up to 172 Weeks, Andreas Wollenberg
- Poster #P0727: Dupilumab Provides Long-Term Efficacy Over 2.5
Years in Adults With Moderate-to-Severe Atopic Dermatitis, Lisa
Beck
- Poster #P0729: Dupilumab Monotherapy Provides Long-Term Control
and Prevents Flares in Adults With Moderate-to-Severe Atopic
Dermatitis Optimally Responding at Week 16, Andreas Wollenberg
Quality of Life Data for Dupixent in Atopic
Dermatitis
- Poster #P0239: Dupilumab Improves Family Quality of Life in
Children Aged 6-11 Years With Severe Atopic Dermatitis: An Analysis
From the Phase 3 LIBERTY AD PEDS Trial, Amy Paller
- Poster #P0252: Dupilumab Provides Long-Term Improvement of
Sleep Loss in Children, Adolescents, and Adults With Atopic
Dermatitis, Lisa Beck
- Poster #P0722: Dupilumab Monotherapy Provides Long-Term
Improvement in Quality of Life in Adults With Moderate-to-Severe
Atopic Dermatitis Optimally Responding at Week 16, Carlos
Ferrándiz
Additional Efficacy and Safety Analyses of Dupixent in
Atopic Dermatitis
- Poster #P0230: Dupilumab Treatment in Adult Patients Is
Efficacious Regardless of Age at Atopic Dermatitis Onset, Jonathan
Silverberg
- Poster #P0231: Dupilumab in Children Aged ≥ 6 to < 12 Years
Promotes Rapid Improvement in Clinical Signs of Atopic Dermatitis,
Amy Paller
- Poster #P0251: Infections in Dupilumab Pediatric Clinical
Trials in Atopic Dermatitis — A Pooled Analysis, Amy Paller
- Poster #P0255: Dupilumab Significantly Improves Treatment
Response in Children With Severe Atopic Dermatitis From the
Patient’s Perspective and by Clinical Assessments of Signs,
Symptoms, and Quality of Life: Results From the LIBERTY AD PEDS
Phase 3 Clinical Trial, Stephan Weidinger
- Poster #P0256: Dupilumab Treatment Is Efficacious in Adult
Atopic Dermatitis Patients Independent of History of Mental Health
Disorders: A Post Hoc Analysis of Pooled Phase 3 Trials, Jonathan
Silverberg
- Poster #P0260: Dupilumab Treatment Is Efficacious in Adult
Atopic Dermatitis Patients Regardless of History of Infection: A
Pooled Analysis of Four Phase 3 Trials, Andreas Wollenberg
- Poster #P0733: Dupilumab Monotherapy Provides 1 Year Sustained
Response in Adults With Moderate-to-Severe Atopic Dermatitis
Optimally Responding at Week 16, With No Need of Concomitant
Topical Steroids, Margitta Worm
Real-World Analyses
- Poster #P0257: Improvement in Disease Severity and Quality of
Life in Patients With Atopic Dermatitis Treated With Dupilumab for
up to 18 Months: Real-World Data From the PROSE Registry, Jerry
Bagel
- Poster #P0259: Use of Systemic Therapies in Adults With Atopic
Dermatitis: 18-Month Results From the European Prospective
Observational Study in Patients Eligible for Systemic Therapy for
Atopic Dermatitis (EUROSTAD), Marjolein De Bruin-Weller
- Poster #P0272: Real-World Use of Dupilumab Among Adults With
Atopic Dermatitis and Its Impact on Healthcare Utilization in
Japan, Ken Igawa
Abstracts presenting research on patient education,
health-related quality of life and burden of disease in atopic
dermatitis include:
- Poster #P0208: The Importance of Patient Education and
Communication: Results from the Atopic Dermatitis Quality of Care
Initiative, Eric Simpson
- Poster #P0254: Relative Importance of Distinct Aspects of
Quality of Life for Patients Aged 6–11 and 12–17 Years Old With
Atopic Dermatitis, Caregivers, and Physicians (AD-GAP), Stephan
Weidinger
- Poster #P0271: Prevalence and Characteristics of Prurigo
Nodules in Adults With Moderate-to-Severe Atopic Dermatitis in
Japan: Results From a 2-Year Observational Study, Yoko Kataoka
About Dupixent
Dupixent is a fully human monoclonal antibody
that inhibits the signalling of the interleukin-4 (IL-4) and
interleukin-13 (IL-13) pathways. Dupixent is not an
immunosuppressant and does not require lab monitoring. IL-4 and
IL-13 are key and central drivers of the type 2 inflammation that
plays a major role in atopic dermatitis, asthma and chronic
rhinosinusitis with nasal polyposis (CRSwNP).
Dupixent is currently approved in the U.S.,
Europe, Japan and other countries around the world for use in
specific patients with moderate-to-severe atopic dermatitis, as
well as certain patients with asthma or CRSwNP in different age
populations. Dupixent is also approved in one or more of these
indications in more than 60 countries around the world and more
than 300,000 patients have been treated 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 60 clinical trials involving more
than 10,000 patients with various chronic diseases driven in part
by type 2 inflammation.
Sanofi and Regeneron are studying dupilumab in a
broad range of diseases driven by type 2 inflammation or other
allergic processes, including pediatric asthma (6 to 11 years of
age, Phase 3), chronic obstructive pulmonary disease with evidence
of type 2 inflammation (Phase 3), pediatric atopic dermatitis (6
months to 5 years of age, Phase 3), eosinophilic esophagitis (Phase
3), bullous pemphigoid (Phase 3), prurigo nodularis (Phase 3),
chronic spontaneous urticaria (Phase 3), chronic inducible
urticaria-cold (Phase 3), chronic rhinosinusitis without nasal
polyposis (Phase 3), allergic fungal rhinosinusitis (Phase 3),
allergic bronchopulmonary aspergillosis (Phase 3) and peanut
allergy (Phase 2). 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 Sanofi
Sanofi is dedicated to supporting people through
their health challenges. We are a global biopharmaceutical company
focused on human health. We prevent illness with vaccines, provide
innovative treatments to fight pain and ease suffering. We stand by
the few who suffer from rare diseases and the millions with
long-term chronic conditions.
With more than 100,000 people in 100 countries,
Sanofi is transforming scientific innovation into healthcare
solutions around the globe.
About Regeneron
Regeneron (NASDAQ: REGN) is a leading
biotechnology company that invents life-transforming medicines for
people with serious diseases. Founded and led for over 30 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
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For additional information about the company,
please visit www.regeneron.com or follow @Regeneron on Twitter.
Sanofi Media Relations
ContactsSally BainTel: +1 (781)
264-1091Sally.Bain@sanofi.com
Regeneron Media Relations
ContactHannah KwaghTel: +1
914-847-6314Hannah.Kwagh@regeneron.com
Investor Relations Contacts
ParisEva Schaefer-JansenArnaud DelepineNathalie Pham
Investor Relations Contacts North
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Tel.: +33 (0)1 53 77 45
45investor.relations@sanofi.comhttps://www.sanofi.com/en/investors/contact
Regeneron Investor Relations
ContactVesna TosicTel: +1
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