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. 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., 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. 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 Dermatitis
Atopic dermatitis, a form of eczema, is a chronic inflammatory disease with symptoms often appearing as a rash on the skin.,,, 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. Itch is one of the most burdensome symptoms for patients and can be debilitating. 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.,
Sanofi, 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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 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.
 Dupixent Summary of Product Characteristics.
 Simpson et al. Two Phase 3 Trials of Dupilumab versus Placebo in Atopic Dermatitis. NEJM, vol. 375, pp. 2335-2348, 2016.
 Dupixent Prescribing Information 2017. https://www.regeneron.com/sites/default/files/Dupixent_FPI.pdf. Accessed August 2017.
 Eichenfield et al. Guidelines of Care for Atopic Dermatitis. AAD 2014, pp. 118.
 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.
 Gelmetti and Wolleberg, BJD 2014, Atopic dermatitis- all you can do from the outside. Page 19.
 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.
 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.
 Zuberbier T et al. Patient perspectives on the management of atopic dermatitis. J Allergy Clin Immunol vol. 118, pp. 226-232, 2006.
 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.