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Sanofi Announces Presentation of 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

 

Guildford, UK – 16 September, 2017Sanofi and its specialty care global business unit, Sanofi Genzyme, today announced 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, met its primary endpoint.1 In the study, dupilumab with topical corticosteroids (TCS) significantly improved measures of overall disease severity, skin clearing, itching, and patient reported health-related quality of life measures. The results of this study are being presented at the European Academy of Dermatology and Venereology (EADV) Congress in Geneva, Switzerland.

“These data complement the results of the previous three Phase 3 studies, further supporting the efficacy and safety of dupilumab for adults with moderate-to-severe atopic dermatitis. The significant improvement of extent and severity of disease signals that this could be an important treatment option for patients living with atopic dermatitis,” said Dr. Mahreen Ameen, consultant dermatologist, Royal Free London NHS Foundation Trust. “This new study demonstrates that dupilumab with topical corticosteroids can effectively alleviate some of the debilitating symptoms experienced by patients living with this long-term condition.”

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.1 EASI is a tool used to measure the extent and severity of the disease. 59 percent of patients who received dupilumab weekly with TCS and 63 percent of patients who received dupilumab 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).1

Although not approved in all countries, ciclosporin A is a broad systemic immunosuppressant used for the treatment of AD in several European countries and Japan.

LIBERTY AD CAFÉ was a 16-week Phase 3, double-blind, randomised, placebo-controlled trial. A total of 325 patients in Europe were randomised into three treatment groups to receive either dupilumab 300 mg weekly with TCS, dupilumab 300 mg every two weeks with TCS or placebo with TCS.1

Secondary endpoints of the study included measures of the impact of dupilumab on the persistent itch caused by the disease, health-related quality of life measures, and symptoms of anxiety and depression. The results for secondary endpoints at 16 weeks include:1

  • The mean percent change improvement in EASI from baseline was 78 percent and 80 percent for patients who received dupilumab weekly or every two weeks with TCS, respectively, compared to 47 percent for those who received placebo plus TCS (p less than 0.0001).
  • 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 dupilumab 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 health-related quality of life, as measured by the Dermatology Life Quality Index (DLQI), was 78 percent and 88 percent in patients who received dupilumab 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 AD, as measured by the Patient Oriented Eczema Measure (POEM), a tool that quantifies the illness as experienced by the patients, was 77 percent and 84 percent in patients who received dupilumab 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 previously undescribed adverse events were observed in the study up to the data lock point. The proportion of patients reporting an adverse event was similar among the treatment arms. Conjunctivitis was more frequent in patients who received dupilumab with TCS, with 16 percent and 28 percent reported in patients who received dupilumab weekly or every two weeks with TCS, respectively, compared to 11 percent for patients who received placebo with TCS. Skin infections were reported in 4 percent and 2 percent among patients who received dupilumab weekly or every two weeks with TCS, respectively, compared to 8 percent for patients who received placebo with TCS. In this study, dupilumab was well tolerated with an acceptable safety profile.

About dupilumab

Dupilumab is an investigational fully human monoclonal antibody. It is a targeted immunotherapy that inhibits signaling of IL-4 and IL-13, two key cytokines required for the Type2 (including Th2) immune response, which is believed to be a fundamental driver of inflammation associated with atopic dermatitis.

The European Commission (EC) is expected to adopt a final decision on the Marketing Authorisation Application (MAA) for dupilumab in the European Union, following positive opinion from the Committee for Medicinal Products for Human Use (CHMP) on 21 July, 2017.

Dupilumab is being developed jointly by Regeneron and Sanofi Genzyme, the specialty care global business unit of Sanofi.

About Atopic Dermatitis

Atopic dermatitis (also known as atopic eczema) is the most common form of eczema.2 In the United Kingdom, approximately 1.5 million (3%) adults have atopic dermatitis.3,4 Within the general UK population, it is estimated that there are 14 adults per 100,000 with moderate atopic dermatitis and 6 adults per 100,000 with severe atopic dermatitis who may be eligible for treatment with dupilumab.5Moderate-to-severe atopic dermatitis is characterised by rashes often covering much of the body, and can include intense, persistent itching and skin dryness, cracking, redness, crusting, and oozing.6 Itch is one of the most burdensome symptoms for patients and can be debilitating. In addition, people with moderate-to-severe atopic dermatitis experience a high level of disrupted sleep, and increased anxiety and depression symptoms due to their disease.7

About Sanofi

Sanofi, a global healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients' needs. Sanofi is organised 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.


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 NHS Choices. Atopic Eczema (Atopic Dermatitis). Available at: http://www.nhs.uk/conditions/Eczema-(atopic)/Pages/Introduction.aspx (Accessed: September 2017).

3 Nutten S. Atopic Dermatitis: Global Epidemiology and Risk Factors. Ann Nutr Metab 2015;66 (suppl 1): 8–16.

4 Office for National Statistics. 2014 UK mid-year population estimate. Available at: http://www.ons.gov.uk/generator?uri=/peoplepopulationandcommunity/populationandmigration/populationestimates/articles/overviewoftheukpopulation/february2016/ff1144ea&format=xls (Accessed:  September 2017).

5 Sanofi. Data on File. January 2017.

6 National Institutes of Health (NIH). Handout on Health: Atopic Dermatitis (A type of eczema) July 2016. Available at:https://www.niams.nih.gov/health_info/atopic_dermatitis/default.asp( Accessed: September 2017).

7 Simpson et al. Patient burden of moderate to severe atopic dermatitis (AD): Insights from a phase 2b clinical trial of dupilumab in adults,” Am Acad Dermatol, pp. 74(3):491-498, 2016.

Date of preparation: September 2017 - Job bag number:SAGB.DUP.17.09.11116

Updated: September 16, 2017

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