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Author: Anoma Ranaweera, Medical Writer. Chief Editor: Dr Amanda Oakley, Dermatologist, Hamilton, New Zealand, January 2017.
Dupilumab (Dupixent®; Sanofi, Paris, France; Regeneron, New York, USA) is a fully human monoclonal antibody, which has shown significant efficacy and a favourable safety profile in moderate-to-severe atopic dermatitis alone and in combination with topical corticosteroids.
The U.S. Food and Drug Administration (FDA) approved Dupixent® as a treatment for moderate-to-severe atopic dermatitis in adults in March 2017, in patients aged 12–17 in March 2019, and in children age 6–11 in May 2020. It was approved by Therapeutic Goods Administration (TGA) in Australia in January 2018, and it was classified as a prescription medicine by Medsafe in New Zealand in March 2018.
The Biologics License Application (BLA) for dupilumab contains data from three pivotal phase 3 clinical studies evaluating dupilumab as monotherapy and in concomitant administration with topical corticosteroids.
Severe atopic dermatitis in adults
Most common (> 5%) adverse reactions associated with dupilumab treatment in clinical trials were:
No drug-specific blood-test monitoring is required.
Rarely, induction of another skin disorder has been reported, such as psoriasis.
Mild conjunctivitis is managed with lubricating eye drops. Patients on dupilumab should be advised to use these from the onset of treatment to prevent ocular symptoms. Some patients may require other treatment.
If you are not based in New Zealand, we suggest you refer to your national drug approval agency for further information about medicines (eg, the Australian Therapeutic Goods Administration and the US Food and Drug Administration) or a national or state-approved formulary (eg, the New Zealand Formulary and New Zealand Formulary for Children and the British National Formulary and British National Formulary for Children).
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