PARIS and TARRYTOWN, N.Y., May
16, 2018 /PRNewswire/ -- A pivotal Phase 3 trial
evaluating Dupixent® (dupilumab) to treat
moderate-to-severe atopic dermatitis in adolescents (ages 12-17)
met its primary and key secondary endpoints. In the trial,
treatment with Dupixent as monotherapy significantly improved
measures of overall disease severity, skin clearing, itching, and
certain health-related quality of life measures. Dupixent is the
first and only biologic to show positive results in this patient
population.
"Moderate-to-severe atopic dermatitis can place a
particularly significant burden on adolescents, who have to deal
with oozing skin lesions with unrelenting, intense itching during
their formative years," said George D.
Yancopoulos, M.D., Ph.D., President and Chief Scientific
Officer of Regeneron. "Dupixent blocks the IL-4/IL-13 pathway,
which is emerging as a central driver of Type 2 allergic
inflammation. We are committed to investigating the potential for
Dupixent across Type 2 inflammatory diseases with high unmet need
including atopic dermatitis, asthma, eosinophilic esophagitis,
nasal polyps, chronic obstructive pulmonary disease, and food
allergy."
Patients treated with Dupixent had significant improvement in
disease severity at 16 weeks
The primary endpoints were the proportion of patients achieving
Investigator's Global Assessment (IGA) score of 0 (clear) or 1
(almost clear) and 75% improvement in Eczema Area and Severity
Index (EASI-75, co-primary endpoint outside of the U.S.) at 16
weeks. Results included:
- 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 0.0001, and
p=0.0007, respectively).
- 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 0.0001).
- 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 0.0001).
- 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 0.0001).
"Current treatment options for these adolescent patients such
as topical steroids, oral steroids, and non-steroidal
immunosuppressants can have significant side effects," said
Elias Zerhouni, M.D., President,
Global R&D, Sanofi. "We continue to explore Dupixent's role in
targeting Type 2 inflammation as an underlying cause of atopic
dermatitis to potentially provide adolescents, some of whom have
lived with this disease their entire lives, a therapy that treats
more than just their symptoms."
Dupixent safety profile was consistent with that seen in
adults
For the 16-week treatment period, the overall rate of adverse
events was comparable between the Dupixent groups and placebo (72%
for Dupixent every two weeks, 64% for Dupixent every four weeks and
69% for placebo). There were no serious adverse events or events
leading to treatment discontinuation in either Dupixent treatment
group.
Adverse events that were observed at a higher rate 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).
Detailed results from this trial will be presented at a future
medical meeting. These data will be submitted to regulatory
authorities later this year. 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.
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, randomized, double-blind,
placebo-controlled trial evaluated the efficacy and safety of
Dupixent monotherapy in adolescent patients with moderate-to-severe
atopic dermatitis. 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. In total, 92% of these patients suffered from at least
one concurrent allergic condition such as allergic rhinitis, asthma
or food allergy.
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. A co-primary endpoint 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 tool used to
measure the extent and severity of the disease.
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.
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.i,ii,iii,iv
Moderate-to-severe atopic dermatitis is characterized by rashes
often covering much of the body, and can include intense,
persistent itching and skin dryness, cracking, redness, crusting,
and oozing.v Itch is one of the most
burdensome symptoms for patients and can be
debilitating.vi In addition, patients with
moderate-to-severe atopic dermatitis experience a substantial
burden of disease, including painful skin lesions and intense
pruritus.6
Dupilumab Development Program
Sanofi and Regeneron are studying dupilumab in a broad range of
clinical development programs for diseases driven by Type 2
inflammation, including asthma (Phase 3), pediatric atopic
dermatitis (Phase 3, ages 6 months - 11 years), nasal polyps (Phase
3) and eosinophilic esophagitis (Phase 2). Future trials are
planned for chronic obstructive pulmonary disease, grass allergy
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.
For more information on dupilumab clinical trials please visit
www.clinicaltrials.gov.
About Dupixent® (dupilumab)
Dupixent is currently approved in the U.S. for the treatment of
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 also approved
for use in certain patients with moderate-to-severe atopic
dermatitis in a number of other countries, including the countries
of the European Union, Canada, and
Japan. The safety and efficacy of
Dupixent in the adolescent atopic dermatitis population have not
been fully evaluated by any regulatory authority.
In addition, the potential use of Dupixent for the treatment of
certain adults and adolescents with inadequately controlled
moderate-to-severe asthma is currently under regulatory review in
the U.S. and European Union, and the safety and efficacy for this
use have not been fully evaluated by any regulatory authority.
IMPORTANT SAFETY INFORMATION AND INDICATION
Do not use if you are allergic to dupilumab or to
any of the ingredients in Dupixent.
Before using Dupixent, tell your healthcare provider about
all your medical conditions, including if you:
- have eye problems
- have a parasitic (helminth) infection
- have asthma
- are scheduled to receive any vaccinations. You should not
receive a "live vaccine" if you are treated with Dupixent.
- are pregnant or plan to become pregnant. It is not known
whether Dupixent will harm your unborn baby.
- are breastfeeding or plan to breastfeed. It is not known
whether Dupixent passes into your breast milk.
Tell your healthcare provider about all the medicines you take,
including prescription and over-the-counter medicines, vitamins and
herbal supplements. If you have asthma and are taking asthma
medicines, do not change or stop your asthma medicine without
talking to your healthcare provider.
Dupixent can cause serious side effects, including:
- Allergic reactions. Stop using Dupixent and go to the
nearest hospital emergency room if you get any of the following
symptoms: fever, general ill feeling, swollen lymph nodes, hives,
itching, joint pain, or skin rash.
- Eye problems. Tell your healthcare provider if you have
any new or worsening eye problems, including eye pain or changes in
vision.
The most common side effects include injection site
reactions, eye and eyelid inflammation, including redness, swelling
and itching, and cold sores in your mouth or on your lips.
Tell your healthcare provider if you have any side effect that
bothers you or that does not go away. These are not all the
possible side effects of Dupixent. Call your doctor for medical
advice about side effects. You may report side effects to the FDA
at 1-800-FDA-1088.
Use Dupixent exactly as prescribed. If your healthcare provider
decides that you or a caregiver can give Dupixent injections, you
or your caregiver should receive training on the right way to
prepare and inject Dupixent. Do not try to inject
Dupixent until you have been shown the right way by your healthcare
provider.
Please click here for the full
Prescribing Information. The patient information is
available here.
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. Dupixent is administered by subcutaneous
injection at different injection sites every two weeks after an
initial loading dose. Dupixent is intended for use under the
guidance of a healthcare provider. A patient may self-inject
Dupixent after training in subcutaneous injection technique using
the pre-filled syringe.
About Sanofi
Sanofi (NYSE: SNY; EURONEXT: SAN) 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, Empowering Life
About Regeneron Pharmaceuticals, Inc
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 disease, heart disease, allergic and inflammatory
diseases, pain, cancer, 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 Twitter.
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i Eichenfield et al. Guidelines of Care for Atopic Dermatitis. AAD
2014, pp. 118.
ii 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.
iii Gelmetti and Wolleberg, BJD 2014, Atopic dermatitis- all you
can do from the outside. Page 19.
iv 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.
v 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.
vi Zuberbier T et al. Patient perspectives on the management of
atopic dermatitis. J Allergy Clin Immunol vol. 118, pp. 226-232,
2006.
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