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Dupilumab

Author: Anoma Ranaweera, Medical Writer. Chief Editor: Dr Amanda Oakley, Dermatologist, Hamilton, New Zealand, January 2017.


Dupilumab — codes and concepts
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What is dupilumab?

Dupilumab is an innovative first-in-class biological treatment 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 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.

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.
  • Dupilumab is intended as a long-term treatment.
  • If discontinued for any reason, it can be restarted.

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.

Rarely, induction of another skin disorder has been reported, such as psoriasis.

Treatment of conjunctivitis

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.

  • Topical corticosteroid drops
  • Topical tacrolimus eyelid ointment
  • Referral to an ophthalmologist

Dupilumab is 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 a 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, emollients, phototherapy and systemic agents (such as prednisone, ciclosporin, methotrexate or azathioprine) can be continued during treatment with dupilumab. The dose of systemic agents may need to be reduced and they can be weaned off as the dupilumab begins to control the dermatitis.

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.

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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Related information

 

References

  • Simpson EL, Bieber T, Guttman-Yassky E, Beck LA, et al. Two Phase 3 Trials of Dupilumab versus Placebo in Atopic Dermatitis. N Engl J Med. 2016 Dec 15;375(24):2335–2348. PubMed.
  • Simpson EL, Gadkari A, Worm M, Soong W, et al. Dupilumab therapy provides clinically meaningful improvement in patient-reported outcomes (PROs): A phase IIb, randomized, placebo-controlled, clinical trial in adult patients with moderate to severe atopic dermatitis (AD). J Am Acad Dermatol. 2016 Sep; 75(3):506–15. PubMed.
  • Simpson EL, Bieber T, Eckert L, Wu R, et al. Patient burden of moderate to severe atopic dermatitis (AD): Insights from a phase 2b clinical trial of dupilumab in adults. J Am Acad Dermatol. 2016 Mar;74(3):491–8. PubMed.
  • Thaçi D, Simpson EL, Beck LA, Bieber T,  et al. Efficacy and safety of dupilumab in adults with moderate-to-severe atopic dermatitis inadequately controlled by topical treatments: a randomised, placebo-controlled, dose-ranging phase 2b trial. Lancet. 2016 Jan 2;387(10013):40–52. PubMed.
  • Tsianakas A, Ständer S. Dupilumab: a milestone in the treatment of atopic dermatitis. Lancet. 2016 Jan 2; 387(10013):4-5. PubMed.
  • Hamilton JD, Suárez-Fariñas M, Dhingra N, Cardinale I, Li X, Kostic A et al. Dupilumab improves the molecular signature in skin of patients with moderate-to-severe atopic dermatitis. J Allergy Clin Immunol. 2014 Dec; 134(6):1293–300. PubMed.
  • Varma, Aakaash et al. Dupilumab-induced phenotype switching from atopic dermatitis to psoriasis. JAAD Case Reports 2020; 6(3): 217–218
  • Pistone G, Tilotta G, Gurreri R, Castelli E, Curiale S, Bongiorno MR. Ocular surface disease during dupilumab treatment in patients with atopic dermatitis, is it possible to prevent it? J Eur Acad Dermatol Venereol. 2020 Jan 27. doi: 10.1111/jdv.16234. Epub ahead of print. PMID: 31985084.

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