Dupixent®
(dupilumab) pivotal trial meets all
primary and secondary endpoints becoming first biologic
medicine to significantly reduce signs and
symptoms of moderate-to-severe
atopic dermatitis in children as young as 6
months
- Dupixent rapidly improved symptoms after first dose, improving
itch in one week and skin clearance in two weeks
- More than seven times as many patients treated with Dupixent
plus topical corticosteroids (TCS) achieved clear or almost clear
skin compared to TCS alone at Week 16
- Dupixent plus TCS reduced overall disease severity by 70% and
itch by 49%
- Results reinforce well-established safety profile of Dupixent -
the first ever biologic medicine for atopic dermatitis currently
approved for patients as young 6 years old
PARIS and TARRYTOWN, N.Y. –
August 30,
2021 - A pivotal Phase 3 trial evaluating
Dupixent® (dupilumab) for the treatment of children aged 6 months
to 5 years with moderate-to-severe atopic dermatitis, a chronic
type 2 inflammatory disease, met its primary and all secondary
endpoints. The data show adding Dupixent to standard of care
topical corticosteroids (TCS) significantly reduced overall disease
severity and improved skin clearance, itch, and health-related
quality of life measures at 16 weeks compared to TCS alone.
Dupixent is the first biologic medicine to show positive results in
this young population and remains the only approved biologic
medicine in patients 6 years and older with uncontrolled
moderate-to-severe atopic dermatitis.
The data reinforce the well-established efficacy
and safety profile of Dupixent in other age groups including a
lower observed rate of skin infection in the Dupixent group
compared with placebo. During the 16-week treatment period Dupixent
patients were 50% less likely to experience a skin infection (12%
Dupixent, 24% placebo), and the total number of infections was
nearly 70% lower (11 Dupixent, 34 placebo). These results add to
the extensive LIBERTY AD clinical program – the largest Phase 3
clinical trial program in atopic dermatitis involving approximately
3,500 children, adolescents, and adults to date.
“When a child is diagnosed with
moderate-to-severe atopic dermatitis in the first few months of
life, many aspects of their childhood can be significantly
impacted. Parents and caregivers are challenged to find safe and
effective treatment options,” said John Reed, M.D., Ph.D., Global
Head of Research and Development at Sanofi. “Currently, the
standard of care for this patient population is topical steroids
and other immunosuppressive medicines may be used which can damage
delicate skin and, if used long-term, potentially impact growth.
Knowing that safety is of the utmost importance for physicians and
parents when considering treatment options for children and
infants, we are encouraged by the results of this trial showing
Dupixent addressed the signs and symptoms of atopic dermatitis
without broadly suppressing the immune system, demonstrating the
potential it could have for these very young patients.”
Atopic dermatitis is a chronic type 2
inflammatory disease, with the age of onset younger than 5 years in
85-90% of patients. The debilitating symptoms that infants and
young children with moderate-to-severe atopic dermatitis experience
often continue through adulthood and include intense, persistent
itch and skin lesions that can cover much of the body, resulting in
skin dryness, cracking, redness or darkening, crusting and oozing –
along with increased risk of skin infections. Moderate-to-severe
atopic dermatitis significantly impacts the life of a young child,
their parents and caregivers, including their mood, sleep patterns,
and quality of life. In addition, the underlying type 2
inflammation involved in atopic dermatitis can contribute to the
development of other atopic diseases, like asthma, that may also
appear throughout a person’s life.
“Moderate-to-severe atopic dermatitis in infants
and young children is incredibly distressing for patients and their
caregivers, who manage painful and persistent itch, intensive daily
skincare routines such as chlorine baths and wet wraps, as well as
sleepless nights for children and their families,” said George D.
Yancopoulos, M.D., Ph.D., President and Chief Scientific Officer at
Regeneron. “In fact, when starting this trial, the disease covered
more than half of children’s bodies and nearly a third had
previously resorted to using immunosuppressive medicines. These
data show that Dupixent dramatically reduced the impact of atopic
dermatitis on the lives of these young children and their families,
by rapidly clearing skin, improving itch, and improving observed
patient outcomes including sleep and skin pain. In fact,
Dupixent-treated patients experienced nearly 70% fewer skin
infections compared to placebo patients.”
Patients received Dupixent every four weeks (200
mg or 300 mg, based on body weight) plus TCS or TCS alone
(placebo). The primary endpoints assessed the proportion of
patients achieving an Investigator's Global Assessment (IGA) score
of 0 (clear) or 1 (almost clear) and 75% improvement in Eczema Area
and Severity Index (EASI-75). The pre-specified primary analysis
showed that at 16 weeks patients treated with Dupixent:
- 28% achieved clear or almost-clear
skin compared to 4% with placebo (p=<0.0001), the primary
endpoint.
- 53% achieved 75% or greater overall
disease improvement from baseline compared to 11% with placebo
(p=<0.0001), the co-primary endpoint outside of the U.S.
- 70% average improvement from
baseline in EASI compared to 20% improvement with placebo
(p=<0.0001).
- 49% average improvement from
baseline in itch compared to 2% improvement in placebo
(p<0.0001).
- Significantly improved measures of
observed patient outcomes (including sleep, skin pain and
health-related quality of life), as well as caregiver-reported
health-related quality of life.
The trial demonstrated similar safety results to
the known safety profile of Dupixent in atopic dermatitis. For the
16-week treatment period, overall rates of adverse events (AEs)
were 64% for Dupixent and 74% for placebo. Most common AEs and AEs
of special interest included nasopharyngitis (8% Dupixent, 9%
placebo), upper respiratory tract infection (6% Dupixent, 8%
placebo) and conjunctivitis (5% Dupixent, 0% placebo), herpes viral
infections (6% Dupixent, 5% placebo) and injection site reactions
(2% Dupixent, 3% placebo).
Dupixent is a fully human monoclonal antibody
that inhibits the signaling of the interleukin-4 (IL-4) and
interleukin-13 (IL-13) pathways. It 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 (CRSwNP).
Detailed results from this trial will be
presented at a future medical meeting, and data will be submitted
to regulatory authorities. In 2016, the U.S. Food and Drug
Administration (FDA) granted Breakthrough Therapy Designation for
Dupixent for the treatment of severe atopic dermatitis (in children
aged 6 months to 11 years of age). The use of Dupixent in children
younger than 6 years of age with moderate-to-severe atopic
dermatitis is currently under clinical investigation and its safety
and efficacy have not been fully evaluated by any regulatory
authority.
About the Dupixent TrialLIBERTY
AD PRESCHOOL is a two-part Phase 2/3 trial. The Phase 3 randomized,
double-blind, placebo-controlled trial (Part B) evaluated the
efficacy and safety of Dupixent added to standard-of-care
low-potency TCS compared to low-potency TCS alone (placebo) in 162
children aged 6 months to 5 years with uncontrolled
moderate-to-severe atopic dermatitis.
The primary endpoints assessed the proportion of
patients achieving an IGA score of 0 (clear) or 1 (almost clear)
and 75% improvement in EASI-75 at 16 weeks. EASI measures extent
and severity of the disease. It was assessed using a 0-10 numerical
rating scale. Patients treated with Dupixent received either 200 mg
(for children weighing ≥5 to <15 kg) or 300 mg (for children
weighing ≥15 to <30 kg) every four weeks.
In total, there were 162 patients in the trial,
the average age was 3.8 years and 61% were male. Approximately 12%
of patients were Latino/Hispanic and 19% were Black/African
American. On average, patients entered the trial with atopic
dermatitis covering 58% of their body and 29% had previously used
systemic immunosuppressants. Further, 81% of these patients had at
least one concurrent type 2 inflammatory disease.
Part B of the Phase 3 trial was informed by Part
A, an open-label, single-ascending-dose, sequential cohort Phase 2
trial designed to assess the pharmacokinetics and safety of
Dupixent in children aged 6 months to 5 years with uncontrolled
severe atopic dermatitis.
Children who completed Part A or Part B of the
trial were eligible to enroll in an open-label extension trial to
assess the safety and efficacy of long-term treatment with Dupixent
in this age group.
About Dupixent 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 ProgramTo
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),
EoE (Phase 3), bullous pemphigoid (Phase 3), prurigo nodularis
(Phase 3), CSU (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. Dupilumab is
being jointly developed by Sanofi and Regeneron under a global
collaboration agreement.
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 world.
For additional information about the company,
please visit www.regeneron.com or follow @Regeneron on Twitter.
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.
Sanofi Media Relations Contact
Nicolas Kressmann Tel.: +1 (732) 532-5318
Nicolas.Kressmann@sanofi.com
Regeneron Media Relations ContactsHannah
KwaghTel: +1
914-847-6314Hannah.Kwagh@regeneron.com Sanofi
Investor Relations Contacts Paris Eva
Schaefer-Jansen Arnaud Delepine Nathalie Pham
Sanofi Investor Relations Contacts
North America Felix Lauscher
Tel.: +33 (0)1 53 77 45 45
investor.relations@sanofi.com
https://www.sanofi.com/en/investors/contact
Regeneron Investor RelationsVesna TosicTel: +1
914-847-5443Vesna.Tosic@regeneron.com
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