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TORONTO, Feb. 8, 2018 /CNW/ - Dupixent™ (dupilumab) is now available in Canadafor adult patients living with moderate-to-severe atopic dermatitis (AD) whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.1
AD, a form of eczema, is a chronicinflammatory disease with symptoms often appearing as a rash on the skin.2,3,4,5 Moderate-to-severe AD is characterized 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.7
Dupixent is the first biologic therapy to target one of the main root causes of the inflammation underlying AD rather than to only treat symptoms of the disease. In clinical trials, patients saw a clinically significant improvement in the condition of their skin and reduction in itch after four months of biweekly treatment.8 Phase 3 trials for Dupixent included 274 Canadian patients in 34 investigation sites across the country.
"Dupixent is the first and only systemic therapy approved for atopic dermatitis. During the trials, we saw a dramatic improvement in patients with almost a third of patients who received Dupixent reaching a primary outcome of clear or almost clear skin," says Dr. Kim Papp, dermatologist and trial investigator in Waterloo. "Availability of new therapies like Dupixent will change the lives of many of our patients."
Beyond the physical aspects of AD, a recent report from the Eczema Society of Canada found almost nine in 10 (87 per cent) AD patients believe their daily life is negatively impacted by the condition.9 Specifically, the report revealed that AD contributed to patients' loss of sleep (79 per cent), anxiety (64 per cent) and depression (44 per cent).10
"Often the perception of atopic dermatitis is that it's 'just a rash,' but this disease has a significant impact on patients and their quality of life," says Amanda Cresswell-Melville, Executive Director, Eczema Society of Canada. "Patients have been suffering with significant burden, including insatiable itch, painful rashes that bleed, ooze and crust, lack of sleep, and missed days of work. New treatment options for the moderate-to-severe patient population is a very exciting development."
About Dupixent Dupixent is a human monoclonal antibody that is designed to specifically inhibit overactive signaling of two key proteins, IL-4 and IL-13, which are believed to be major drivers of the persistent underlying inflammation in AD.11 Dupixent is being developed by Sanofi and Regeneron under a joint collaboration agreement, and will be commercialized in Canada by Sanofi Genzyme, the specialty care global business unit of Sanofi.
Dupixent was approved by Health Canada on November 30, 2017. The approval was based on data from the global LIBERTY AD clinical program, which included three randomized Phase 3 pivotal trials known as SOLO 1, SOLO 2 and CHRONOS (enrolled 2,119 total adult patients with inadequately controlled moderate-to-severe AD). SOLO 1 and SOLO 2 examined the use of Dupixent alone, while CHRONOS looked at the use of Dupixent with topical corticosteroids in patients. In all three studies, Dupixent alone or with topical corticosteroids provided rapid and sustained improvement in lesion extent and severity, itch intensity and health-related quality of life measures.12
Dupixent comes in a pre-filled syringe and can be self-administered as a subcutaneous injection every other week after an initial loading dose.13
"Dupixent's availability represents Sanofi Genzyme's commitment to reducing the burden of Canadians living with AD," says Peter Brenders, General Manager, Sanofi Genzyme Canada. "This treatment will offer patients the opportunity for relief from the often-debilitating aspects of the disease and improve the quality of life for adults living with moderate to severe AD."
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References ____________________________1 Dupixent™ (dupilumab) Product Monograph. Page 3. November 30, 2017. 2 Eichenfield et al. Guidelines of Care for Atopic Dermatitis. AAD 2014, pp. 118.3 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 November 27, 2017.4 Gelmetti and Wolleberg, BJD 2014, Atopic dermatitis- all you can do from the outside. Page 19.5 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 November 27, 2017. 6 Mount Sinai. Patient Care Atopic Dermatitis. Available at: http://www.mountsinai.org/patient-care/health-library/diseases-and-conditions/atopic-dermatitis#risk. Accessed November 27, 2017.7 Zuberbier T et al. Patient perspectives on the management of atopic dermatitis. J Allergy Clin Immunol vol. 118, pp. 226-232, 2006.8 Dupixent™ (dupilumab) Product Monograph. Page 22 (Figure 3). November 30, 2017.9 Eczema Society of Canada. (2017). Atopic Dermatitis Quality of Life Report (Moderate-to-Severe Disease – 2016/2017 Survey Results). Keswick, Ontario.10 Eczema Society of Canada. (2017). Atopic Dermatitis Quality of Life Report (Moderate-to-Severe Disease – 2016/2017 Survey Results). Keswick, Ontario.11 Dupixent™ (dupilumab) Product Monograph. Page 3. November 30, 2017. 12 Dupixent™ (dupilumab) Product Monograph. Page 16. November 30, 2017. 13 Dupixent™ (dupilumab) Product Monograph. Page 9. November 30, 2017.
SOURCE Sanofi Genzyme
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