Positive Phase 3 results presented for Dupixent®
(dupilumab) show significant improvement on multiple measures of
disease severity in adolescents with moderate-to-severe atopic
dermatitis
Paris and
Tarrytown, NY - September 15, 2018 - Detailed results from a
pivotal Phase 3 trial showed Dupixent® (dupilumab)
monotherapy demonstrated a significant improvement in signs and
symptoms of atopic dermatitis and certain quality of life measures
in adolescent patients (12-17 years) with moderate-to-severe atopic
dermatitis, whose disease was inadequately controlled with topical
therapies or for whom topical treatment was medically inadvisable.
These data were presented today at the 27th European
Academy of Dermatology and Venereology (EADV) Congress in Paris,
France.
There continues to be a
significant unmet need for adolescents with moderate-to-severe
atopic dermatitis, whose disease cannot be controlled with topical
treatments. There are no systemic biologic medications approved for
this patient population. Dupixent is currently approved for use in
certain adult patients with moderate-to-severe atopic dermatitis in
countries including the U.S., European Union, Canada and Japan. The
results from this trial in adolescents form the basis of regulatory
submissions for patients ages 12 to 17.
"Limited
treatment options leave adolescents with uncontrolled
moderate-to-severe atopic dermatitis to cope with intense,
unrelenting itch and skin lesions," said Amy S. Paller, M.D.,
Director of the Northwestern University Skin Disease Research
Center and principal investigator of the trial. "The results we are presenting today show the potential for
Dupixent in adolescents to not only help clear the skin and reduce
itching, but also improve certain aspects of quality of life in
adolescents who may be dealing with these unbearable
symptoms."
The late-breaking
presentation at EADV included the following data:
The co-primary endpoint outside of
the U.S. was 75% improvement in Eczema Area and Severity Index
(EASI-75) at 16 weeks. In the U.S., the primary endpoint was the
proportion of patients achieving Investigator's Global Assessment
(IGA) score of 0 (clear) or 1 (almost clear):
-
41.5% of patients who received Dupixent every
two weeks and 38% of patients who received Dupixent every four
weeks achieved 75% or greater skin improvement (EASI-75) compared
to 8% with placebo (p less than 0.001).
-
24% of patients who received weight-based dosing
of Dupixent every two weeks (200 mg or 300 mg) and 18% of patients
who received a fixed dose of Dupixent every four weeks (300 mg)
achieved the primary endpoint - clear or almost-clear skin (IGA;
score of 0 or 1) - compared with 2% with placebo (p less than
0.001).
-
There was a 66% improvement in the Dupixent
every two weeks group and 65% improvement in the Dupixent every
four weeks group in average percent change from baseline in EASI
score compared with a 24% improvement in the placebo group (p less
than 0.001).
-
There was a 48% improvement in the Dupixent
every two weeks group and 45.5% improvement in the Dupixent every
four weeks group in average percent change from baseline in the
pruritus numerical rating scale (NRS) compared with a 19%
improvement in the placebo group (p less than 0.001).
Also at 16 weeks, additional
secondary endpoints were:
-
The majority of patients who received Dupixent
(61% of patients treated every two weeks and 55% of patients
treated every four weeks) achieved at least a 50% improvement in
EASI (EASI-50) compared to 13% with placebo (p less than
0.001).
-
There was a 52% improvement in the Dupixent
every two weeks group and 47.5% improvement in the Dupixent every
four weeks group compared to a 18% improvement in the placebo group
in mean percent change from baseline in SCORing Atopic Dermatitis
(SCORAD), a combined measure of area and severity of atopic
dermatitis on the skin as well as patient-reported symptoms of itch
and sleeplessness (p less than 0.001).
-
Itch - 49% of patients who
received Dupixent every two weeks and 39% of patients who received
Dupixent every four weeks achieved at least a 3-point improvement
on the peak pruritus numerical rating scale (pp-NRS) compared to 9%
with placebo (p less than 0.001). At the beginning of the trial,
patients reported a mean itch score of 7.6 on the 10-point pp-NRS
scale.
-
Quality of Life and
Patient-Reported Symptoms - Patients who received Dupixent
every two weeks or every four weeks significantly improved quality
of life measured by the Children's Dermatology Life Quality Index
(CDLQI) and patient-reported symptoms measured by the
Patient-Oriented Eczema Measure (POEM) compared with placebo (p
less than 0.001).
Additionally in the 16-week trial,
59% of patients on placebo used rescue medications compared with
21% of patients receiving Dupixent every two weeks and 32.5% of
patients receiving Dupixent every four weeks.
The overall rate of adverse events
was 72% for Dupixent every two weeks, 64% for Dupixent every four
weeks and 69% for placebo.
Adverse events that were observed
more frequently with Dupixent included injection site reactions
(8.5% for Dupixent every two weeks, 6% for Dupixent every four
weeks compared with 3.5% for placebo) and conjunctivitis (10% for
Dupixent every two weeks, 11% for Dupixent every four weeks
compared with 5% for placebo). Skin infections were numerically
lower in the Dupixent groups (11% for Dupixent every two weeks, 13%
for Dupixent every four weeks compared with 20% for placebo).
The safety and efficacy of
Dupixent in the adolescent atopic dermatitis population have not
been fully evaluated by any regulatory authority.
About the
Dupixent Trial in Adolescent Patients
The pivotal, Phase 3 trial
evaluating the efficacy and safety of Dupixent monotherapy in
adolescent patients with moderate-to-severe atopic dermatitis is
the first Phase 3 trial of a biologic in this patient population.
The trial enrolled 251 patients who were 12 years to 17 years of
age with moderate-to-severe atopic dermatitis whose disease could
not be adequately controlled with topical medications or for whom
topical treatment was medically inadvisable.
Patients were randomized into one
of three treatment groups for the controlled period of 16 weeks:
the first group was treated with Dupixent subcutaneous injection
200 mg or 300 mg every two weeks, based on weight (with an initial
dose of 400 mg or 600 mg respectively). The second group was
treated with 300 mg Dupixent every four weeks (with an initial dose
of 600 mg), and the third group was treated with placebo every two
weeks. No topical corticosteroids were permitted unless a patient
had a severe flare and required rescue medication.
The co-primary endpoints outside
of the U.S. and a key secondary endpoint in the U.S. was the
proportion of patients who achieved 75% or greater skin improvement
as measured by the EASI-75 at Week 16. EASI is a validated scale
used to measure the extent and severity of the disease. In the
U.S., the primary endpoint of this trial was the proportion of
patients with an IGA score of 0 or 1 at Week 16. The IGA is a
5-point scale ranging from 0 (clear) to 4 (severe) that measures
overall severity of skin lesions.
In the trial, 92% of patients had
at least one other atopic or allergic condition, including 66% with
allergic rhinitis, 61% with food allergy, 54% with asthma, 29% with
hives and 23% with allergic conjunctivitis.
About Moderate-to-Severe Atopic
Dermatitis
Atopic dermatitis, a form of
eczema, is a chronic inflammatory disease with symptoms often
appearing as a rash on the skin.[1],[2],[3],[4]
Moderate-to-severe atopic dermatitis is characterized by rashes
that can potentially cover much of the body, and can include
intense, persistent itching, skin lesions and skin dryness,
cracking, redness, crusting and oozing.[5] Itch is one
of the most burdensome symptoms for patients and can be
debilitating.[6]
About Dupixent®
(dupilumab)
Dupixent works by inhibiting
interleukin-4 and interleukin-13 (IL-4 and IL-13), which are
important contributors to Type 2 inflammation, a systemic, allergic
response known to play a role in moderate-to-severe atopic
dermatitis.
In 2016, the U.S. Food and Drug
Administration (FDA) granted Breakthrough Therapy designation for
Dupixent for the treatment of moderate-to-severe (12 to 17 years of
age) and severe (6 months to 11 years of age) atopic dermatitis not
well controlled on topical prescription medications.
Dupixent is currently approved in
the United States as a treatment for adults with moderate-to-severe
atopic dermatitis whose disease is not adequately controlled with
topical prescription therapies or when those therapies are not
advisable. Dupixent is approved in the European Union for use in
adults with moderate-to-severe atopic dermatitis (AD) who are
candidates for systemic therapy. Dupixent is also approved for
certain patients with moderate-to-severe atopic dermatitis in a
number of other countries, including Canada and Japan. More than
50,000 adult patients with atopic dermatitis have been prescribed
Dupixent to date.
About Type 2
Inflammation in Atopic Dermatitis
Through scientific advances in immune based
disease biology, we now understand that a particular type of
inflammation, called Type 2 inflammation, contributes to the cause
of atopic dermatitis.[7] The immune
system includes different immune cells and signaling proteins,
including interleukins. Interleukin-4 (IL-4) and interleukin-13
(IL-13) are central drivers of Type 2 allergic inflammation in
atopic dermatitis, as well as a range of other allergic or atopic
diseases.7
Dupilumab
Development Program
Sanofi and Regeneron are also
studying dupilumab in a broad range of clinical development
programs for diseases driven by Type 2 inflammation, including
asthma (Phase 3), pediatric (6-11 years) atopic dermatitis (Phase
3), nasal polyps (Phase 3), eosinophilic esophagitis (Phase 3) and
grass allergy (Phase 2). Future trials are planned for chronic
obstructive pulmonary disease and food allergy (including peanut).
These potential uses are investigational and the safety and
efficacy have not been evaluated by any regulatory authority.
Dupilumab is being jointly developed by Sanofi and Regeneron under
a global collaboration agreement.
INDICATION
Dupixent is used to treat adult
patients with moderate-to-severe atopic dermatitis (eczema) that is
not well controlled with prescription therapies used on the skin
(topical), or who cannot use topical therapies. Dupixent can be
used with or without topical corticosteroids. It is not known if
Dupixent is safe and effective in children.
About
Regeneron
Regeneron (NASDAQ: REGN) is a
leading biotechnology company that invents life-transforming
medicines for people with serious diseases. Founded and led for 30
years by physician-scientists, our unique ability to repeatedly and
consistently translate science into medicine has led to six
FDA-approved treatments and numerous product candidates in
development, 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, neuromuscular diseases,
infectious diseases and rare diseases.
Regeneron is accelerating and
improving the traditional drug development process through our
proprietary VelociSuite®
technologies, such as VelocImmune®
which produces optimized fully-human antibodies, and 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
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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
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With more than 100,000 people in 100 countries, Sanofi is
transforming scientific innovation into healthcare solutions around
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Sanofi, Empowering Life
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[1] Eichenfield
et al. Guidelines of Care for Atopic Dermatitis. AAD 2014, pp.
118.
[2] Guideline
to treatment, European Dermatology Forum.
http://www.euroderm.org/edf/index.php/edf-guidelines/category/5-guidelines-miscellaneous?download=36:guideline-treatment-of-atopic-eczema-atopic-dermatitis.
Accessed December 23, 2016.
[3] Gelmetti
and Wolleberg, BJD 2014, Atopic dermatitis- all you can do from the
outside. Page 19.
[4] National
Institutes of Health (NIH). Handout on Health: Atopic Dermatitis (A
type of eczema) 2013.
http://www.niams.nih.gov/Health_Info/Atopic_Dermatitis/default.asp.
Accessed October 31, 2016.
[5] Mount
Sinai. Patient Care Atopic Dermatitis. Available at:
http://www.mountsinai.org/patient-care/health-library/diseases-and-conditions/atopic-dermatitis#risk.
Accessed August 2017.
[6] Zuberbier T
et al. Patient perspectives on the management of atopic dermatitis.
J Allergy Clin Immunol vol. 118, pp. 226-232, 2006.
[7] Gandhi NA,
BL Bennett, NM Graham, et al. Targeting key proximal drivers of
type 2 inflammation in disease. Nat Rev Drug Discov
2016;15(1):35-50.
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