Sanofi and Regeneron Announce Positive Study
Results for Dupixent® (dupilumab) in Patients With
Moderate-to-Severe Atopic Dermatitis
- Late-breaking oral abstract of Phase 3 CAFÉ
study presented at the 26th European Academy of Dermatology
and Venereology (EADV) Congress -
Paris, France and Tarrytown, N.Y. - September
16, 2017 - Sanofi and Regeneron Pharmaceuticals, Inc.
announced today positive results from the Phase 3 CAFÉ study of
Dupixent® (dupilumab) in adults with moderate-to-severe atopic
dermatitis (AD) who are inadequately controlled with or intolerant
to the broad immunosuppressant drug cyclosporine A (CSA), or when
this treatment is medically inadvisable.[1] In the
study, Dupixent with topical corticosteroids (TCS) significantly
improved measures of overall disease severity, skin clearing,
itching, and patient reported quality of life measures. CSA
is approved for the treatment of AD in most European countries and
Japan; it is not approved in the U.S. for this use. The
results of this study are being presented at the European Academy
of Dermatology and Venerology (EADV) Congress in Geneva,
Switzerland.
The primary endpoint of the study was the
proportion of patients that achieved a 75 percent or greater
improvement in the Eczema Area and Severity Index (EASI-75) score
at 16 weeks from baseline. EASI is a tool used to measure the
extent and severity of the disease. Fifty-nine percent of patients
who received Dupixent weekly with TCS, and 63 percent of patients
who received Dupixent every two weeks with TCS achieved EASI-75,
compared to 30 percent of those patients who received placebo with
TCS (p less than 0.0001).
The mean percent change improvement in EASI from
baseline at 16 weeks (a secondary endpoint) was 78 percent and 80
percent for patients who received Dupixent weekly or every two
weeks with TCS, respectively, compared to 47 percent for those who
received placebo plus TCS (p less than 0.0001).
"In moderate-to-severe atopic dermatitis, some
patients stop cyclosporine therapy due to intolerance or lack of
efficacy, or are not candidates because of other medical conditions
or contraindicated medications," said Dr. Marjolein De
Bruin-Weller, Dermatologist, National Expertise Center for
Atopic Dermatitis, University Medical Center Utrecht. "In the
CAFÉ study, Dupixent with topical corticosteroids significantly
improved overall measures of disease severity including lesions,
itch, quality of life measures and symptoms of anxiety and
depression in these patients. The safety profile in this
study was consistent with three previous positive Dupixent Phase 3
studies in moderate-to-severe atopic dermatitis."
Other secondary endpoints of the study included
measures of the impact of Dupixent on the persistent itch caused by
the disease, quality of life measures, and symptoms of anxiety and
depression. The results for these secondary endpoints at 16 weeks
include:
- The mean percent improvement from baseline in the intensity of
patient-reported itch, as measured by the pruritus Numerical Rating
Scale (NRS), was 52 percent and 54 percent in patients who received
Dupixent weekly or every two weeks with TCS, respectively, compared
to 25 percent for those who received placebo plus TCS (p less than
0.0001).
- The proportion of patients with a greater than or equal to
four-point improvement from baseline in aspects of patient quality
of life, as measured by the Dermatology Life Quality Index (DLQI),
was 78 percent and 88 percent in patients who received Dupixent
weekly or every two weeks with TCS, respectively, compared to 44
percent of those who received placebo plus TCS (p less than
0.0001).
- The proportion of patients with a greater than or equal to
four-point improvement from baseline in the severity of their AD,
as measured by the Patient Oriented Eczema Measure (POEM), a tool
that quantifies the illness as experienced by the patients, was 76
percent and 83 percent in patients who received Dupixent weekly or
every two weeks with TCS, respectively, compared to 42 percent for
those who received placebo plus TCS (p less than 0.0001).
No
new adverse events were reported in the study. The proportion of
patients reporting an adverse event was similar among the treatment
arms. Conjunctivitis was more frequent in patients who received
Dupixent with TCS, with 16 percent and 28 percent reported in
patients who received Dupixent weekly or every two weeks with TCS,
respectively, compared to 11 percent for patients who received
placebo with TCS. Injection site reactions were reported in 11
percent and 4 percent among patients who received DUPIXENT with TCS
weekly or every two weeks, respectively, compared to 5 percent for
patients who received placebo with TCS. Skin infections were
reported in 4 percent and 2 percent among patients who received
Dupixent weekly or every two weeks with TCS, respectively, compared
to 8 percent for patients who received placebo with TCS.
A total of 325 patients in Europe were
randomized into three treatment groups in the 16-week study to
receive either Dupixent 300 mg weekly with TCS, Dupixent 300 mg
every two weeks with TCS or placebo with TCS.
About Dupixent (dupilumab)Dupixent is a
human monoclonal antibody that is designed to simultaneously
inhibit overactive signaling of IL-4 and IL-13 cytokines.[2],[3] In
addition to moderate-to-severe atopic dermatitis, Sanofi and
Regeneron are studying dupilumab in a broad range of clinical
development programs including uncontrolled persistent asthma
(phase 3), nasal polyps (phase 3) and eosinophilic esophagitis
(phase 2). 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.
In March 2017, the U.S. Food and Drug
Administration (FDA) approved Dupixent® (dupilumab) 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.[4] Dupixent is given as one, 300 mg injection under the
skin (subcutaneous injection) every 2 weeks after an initial
loading dose (600 mg). The European Commission (EC) is expected to
adopt a final decision on the Marketing Authorization Application
(MAA) for Dupixent in the European Union, following the Committee
for Medicinal Products for Human Use (CHMP) adopting a positive
opinion on July 21, 2017.
About Atopic DermatitisAtopic dermatitis,
a form of eczema, is a chronic inflammatory disease with symptoms
often appearing as a rash on the skin.[5],[6],[7],[8]
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.[9] Itch is one of the most burdensome symptoms for
patients and can be debilitating.[10] In addition, patients with
moderate-to-severe atopic dermatitis experience a substantial
burden of disease, including skin lesions, intense pruritus, and
impact on quality of life components, such as sleep and symptoms of
anxiety and depression.[10],[11]
About SanofiSanofi, a global healthcare
leader, discovers, develops and distributes therapeutic solutions
focused on patients' needs. Sanofi is organized into five global
business units: Diabetes and Cardiovascular, General Medicines and
Emerging Markets, Sanofi Genzyme, Sanofi Pasteur and Consumer
Healthcare. Sanofi is listed in Paris (EURONEXT: SAN) and in New
York (NYSE: SNY).
Sanofi Genzyme focuses on developing specialty
treatments for debilitating diseases that are often difficult to
diagnose and treat, providing hope to patients and their
families.
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 nearly 30 years by
physician-scientists, our unique ability to repeatedly and
consistently translate science into medicine has led to six
FDA-approved treatments and over a dozen 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, and infectious and rare diseases.
Regeneron is accelerating and improving the
traditional drug development process through its unique
VelociSuite® technologies and ambitious initiatives such as The
Regeneron Genetics Center, 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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press release contains forward-looking statements as defined in the
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of Digital Media This news release includes forward-looking
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and uncertainties include, among others, the nature, timing, and
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now underway or planned, including without limitation Dupixent®
(dupilumab) Injection; the likelihood, timing, and scope of
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Contacts Sanofi:Media RelationsAshleigh KossTel: +1
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Contacts Regeneron: Media Relations Ilana
TabakTel: 1 (914) 847-3836Mobile: +1 (914)
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[1] de Bruin-Weller et al. Dupilumab in adult patients with
atopic dermatitis and history of inadequate response, intolerance
to, or medically inadvisable for cyclosporine A: a
placebo-controlled, randomized phase 3 clinical trial (Liberty AD
CAFÉ), EADV 2017, Geneva, Switzerland, September 13-17, 2017.
[2] Dupixent Summary of Product Characteristics.
[3] Simpson et al. Two Phase 3 Trials of Dupilumab versus
Placebo in Atopic Dermatitis. NEJM, vol. 375, pp. 2335-2348,
2016.
[4] Dupixent Prescribing Information 2017.
https://www.regeneron.com/sites/default/files/Dupixent_FPI.pdf.
Accessed August 2017.
[5] Eichenfield et al. Guidelines of Care for Atopic Dermatitis.
AAD 2014, pp. 118.
[6] 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.
[7] Gelmetti and Wolleberg, BJD 2014, Atopic dermatitis- all you
can do from the outside. Page 19.
[8] 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.
[9] 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.
[10] Zuberbier T et al. Patient perspectives on the management
of atopic dermatitis. J Allergy Clin Immunol vol. 118, pp. 226-232,
2006.
[11] Torrelo A et al. Atopic dermatitis: impact on quality of
life and patients' attitudes toward its management. Eur J Dermatol
vol. 22(1), pp. 97-105, 2012.
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