Dupilumab

Author: Anoma Ranaweera B.V.Sc; PhD (Clinical Biochemistry, University of Liverpool, UK). Chief Editor: Dr Amanda Oakley, Dermatologist, Hamilton, New Zealand, January 2017.


What is dupilumab?

Dupilumab is an innovative first-in-class biologic agent for atopic dermatitis (eczema).

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 March 2017. It was approved by Therapeutic Goods Adminstration (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.

What is dupilumab used for?

Severe atopic dermatitis in adults

How does dupilumab work? 

  • Dupilumab is thought to work by blocking the inflammation that causes atopic dermatitis.
  • Atopic dermatitis is characterised by type 2 helper T (Th2) cell-driven inflammation,
  • Dupilumab, a fully-human monoclonal antibody, is directed against the shared IL-4 receptor alpha subunit, which blocks signalling from both IL-4 and IL-13.
  • IL-4 and IL-13 are key cytokines (signalling molecules that are made by cells and help to control the immune system and fight disease) that are required for the initiation and maintenance of the Th2 (Type 2 helper T-cell) immune response, which is believed to be a critical pathway in allergic inflammation.

Dosage and administration

  • Dupilumab is administered as a subcutaneous injection.

Link to key clinical-trial evidence about dupilumab

What are the adverse effects of dupilumab?

Most common (> 5%) adverse reactions associated with dupilumab treatment in clinical trials were:

No drug-specific blood-test monitoring is required.

Dupilumab promising for atopic dermatitis in phase 3 studies

  • Dupilumab is a fully human monoclonal antibody that inhibits the actions of both IL-4 and IL-13.
  • Clinical trials of systemic dupilumab in moderate-to-severe atopic dermatitis have demonstrated marked improvement in patient symptoms, including pruritus and clinically visible disease.
  • Importantly, dupilumab treatment has been correlated with changes in the molecular signature of diseased skin, with reduction of both inflammatory and proliferative markers.
  • Topical corticosteroids and emollients can be continued during treatment with dupilumab.
New Zealand approved datasheets are the official source of information for these prescription medicines, including approved uses and risk information. Check the individual New Zealand datasheet on the Medsafe website.

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