Dupixent® (dupilumab) now available in South Africa for treatment of adult patients with moderate-to-severe atopic dermatitis

First targeted biologic in South Africa for use in atopic dermatitis

17 September 2021 – Sanofi has announced that Dupixent® (dupilumab) is now available in South Africa. Dupixent® is indicated for the treatment of adult patients with moderate-to-severe atopic dermatitis (AD) whose disease is not adequately controlled with topical corticosteroid therapies, or when those therapies are not advisable.1

As the first biologic medicine approved for moderate-to-severe AD, Dupixent® has transformed the treatment landscape for patients around the world by targeting the type 2 inflammation that underlies the disease, rather than broadly suppressing the immune system.

 

“The approval of Dupixent® in South Africa is a meaningful advancement for patients and their physicians who have struggled to treat the debilitating symptoms of moderate-to-severe atopic dermatitis, which can seriously impact quality of life,” says Dr Michael Klein, General Manager of Sanofi Genzyme for South Africa, Namibia and Botswana.

AD, a form of eczema, is a chronic, pruritic, inflammatory disease with symptoms often appearing as a rash on the skin.2 Moderate-to-severe AD is characterised by rashes often covering much of the body, and can include intense, persistent itching and skin dryness, cracking, redness, crusting, and oozing.2 Itch is one of the most burdensome symptoms for patients and can be debilitating.3

 

Patients with moderate-to-severe AD experience a substantial burden of disease, including skin lesions and intense itching, which impact quality of life components such as sleep and symptoms of anxiety and depression.4

“The limited treatment options in South Africa for moderate-to-severe atopic dermatitis left many patients and those who care for them struggling to cope with the physical and emotional burden of the disease,” says Dr Klein. “There were few options available in our region to treat people with moderate-to-severe atopic dermatitis. Availability of a targeted treatment like Dupixent® provides hope to adults living with this chronic disease, offering relief from the often unbearable itch and other symptoms that can significantly impact their lives.”

 

Dupixent® is a human monoclonal antibody specifically designed to inhibit signalling of two important cytokines, interleukin-4 (IL-4) and interleukin-13 (IL-13), which contribute to the persistent underlying inflammation in AD and certain other allergic or atopic diseases.1,4 Dupixent® comes in a pre-filled syringe and can be self-administered by a patient as a subcutaneous injection every other week, after an initial loading dose.1 Dupixent® can be used with or without topical corticosteroids.1

“Dupixent® is the first registered biologic therapy for atopic dermatitis in South Africa. It will revolutionise the way South African dermatologists treat patients with moderate-to-severe atopic dermatitis. Dupixent® dramatically improves the quality of life of patients suffering from moderate-to-severe atopic dermatitis. At last, they have hope,” says Dr Willie Visser, Head of Dermatology, Faculty of Medicine and Health Sciences, Stellenbosch University.

 

LIBERTY AD clinical trial and results

Approval of Dupixent® was based on select studies from the global LIBERTY AD clinical trials, which included 2 677 patients.6
LIBERTY AD studies examined the use of Dupixent® either alone (SOLO 1, SOLO 24 and SOLO-CONTINUE) or with topical corticosteroids (CHRONOS7 or CAFÉ8) in moderate-to-severe AD patients who were inadequately controlled with topical prescription therapies or immunosuppresants such as cyclosporine, or for whom those therapies were not advisable.8 In all of these studies, Dupixent® alone or with topical corticosteroids met the primary and other key endpoints.58 The most common adverse events that occurred at a higher rate than placebo in the Dupixent® group (> 1%) included injection site reactions, eye and eyelid inflammation, including redness, swelling, and itching, and cold sores in the mouth or on the lips.68

 

Dupilumab is also being studied in other type 2 inflammatory diseases in which IL-4/IL-13 pathways play a critical role.

 

Dupixent® is jointly developed by Regeneron and Sanofi under a global collaboration agreement.

 

About Sanofi

Sanofi is dedicated to supporting people through their health challenges. As a global biopharmaceutical company focused on human health, we protect people with our vaccines and ease their pain and suffering with our innovative treatments. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.

Sanofi Genzyme, the specialty care global business unit of Sanofi, focuses on rare diseases, multiple sclerosis, oncology and immunology.

With more than 100 000 employees in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.

Sanofi, Empowering Life.

 

References

1 Dupixent Professional Information, South Africa, January 2021

2 Sabin BR, Peters N, Peters AT. Chapter 20: Atopic dermatitis. Allergy Asthma Proc. 2012;33(Suppl 1):67-69. https://doi.org/10.2500/aap.2012.33.3553.

3 Honstein T, Werfel T. An update on clinical experiences and clinical studies on novel pharmaceutical developments for the treatment of atopic dermatitis. Curr Opin Allergy Clin Immunol. 2020;20(4):386-94.

4 Simpson EL, Bieber T, Guttman-Yassky, et al. Two phase 3 trials of dupilumab versus placebo in atopic dermatitis. N Engl J Med. 2017;375(24):2335-48. https://doi.org/10.1056/nejmoa1610020.

5 European Medicines Agency. Dupixent summary of product characteristics. Available from: https://www.ema.europa.eu/en/documents/product-information/dupixent-epar-product-information_en.pdf. Accessed Jan 2017.

6 Beck LA, Thaçi D, Deleuran M, et al. Dupilumab provides favorable safety and sustained efficacy for up to 3 years in an open‑label study of adults with moderate‑to‑severe atopic dermatitis. Am J Clin Dermatol. 2020;21(4): 567-77. https://doi.org/10.1007/s40257-020-00527-x.

7 Blauvelt A, De Bruin-Weller M, Gooderham M, et al. Long-term management of moderate-to-severe atopic dermatitis with dupilumab and concomitant topical corticosteroids (LIBERTY AD CHRONOS): a 1-year, randomised, double-blinded, placebo-controlled, phase 3 trial. Lancet. 2017;389(10086):2287-303. https://doi.org/10.1016/s0140-6736(17)31191-1.

8 De Bruin-Weller M, Thaçi D, Smith CH, et al. Dupilumab with concomitant topical corticosteroid treatment in adults with atopic dermatitis with an inadequate response or intolerance to ciclosporin A or when this treatment is medically inadvisable: a placebo-controlled, randomized phase III clinical trial (LIBERTY AD CAFE). Br J Dermatol. 2018;178(5):1083-101. https://doi.org/10.1111/bjd.16156.