What is Dupixent?

Dupixent (dupilumab) is a biologic drug approved by the FDA for adults and children (6 months and up) with moderate to severe atopic dermatitis.

Moderate to severe atopic dermatitis is generally determined by skin involvement (how much of your body surface is affected) and severity of symptoms such as itch and rash that cannot be controlled by topical medications alone. However, atopic dermatitis can be considered moderate or severe if the disease has a significant negative impact on your quality of life, even if the body surface affected is more limited. It’s important to talk to your doctor about how atopic dermatitis affects not just your skin but also other aspects of your life.

Together, you and your healthcare provider can determine if Dupixent is an appropriate treatment option.

What Type of Medicine is Dupixent?

Dupixent is a biologic, a type of medicine made from living organisms or components from living organisms (like proteins).

Biologics are designed to target specific parts of the immune system that contribute to chronic inflammatory diseases such as atopic dermatitis. Biologics take an “inside out” approach to treating inflammatory conditions.

How Does Dupixent Work?

Dupixent works by blocking a type of protein called interleukins (IL), specifically IL-4 and IL-13, from binding to its cell surface receptors.  IL-4 and IL-13 can be produced by many cells of the immune system and have been found to contribute to the inflammatory processes and decreased barrier functions in atopic dermatitis.

How Do You Take Dupixent?

Dupixent is taken by subcutaneous (s.c.) injection (injection under the skin). Dupixent is not available as a pill or cream.

Like many biologics, Dupixent is an antibody with a unique protein structure, and must be given by injection. If given in a pill, our digestive system would break down the protein structure needed for Dupixent to bind to its target, making the drug ineffective.

The recommended dosage of Dupixent for adults is an initial 600 mg dose followed by 300 mg once every other week.  For children ages 6 months – 17 years, Dupixent has a weight-tiered dosing regimen that includes an initial dose followed by either every other week or once monthly dosing.

How Effective is Dupixent for Atopic Dermatitis?

In the LIBERTY AD SOLO 1 and 2 monotherapy adult clinical trials for Dupixent (i.e. Dupixent used as a single therapy taken every other week), after 16 weeks on Dupixent1,2:

  • Primary Clinical Trial Endpoints:
    • Investigator Global Assessment (IGA)
      • A tool used to provide a clinical trial investigator rating of overall disease severity at a particular time point.
      • 36-38% of patients achieved clear or almost-clear skin (IGA 0 or 1) versus 9-10% on placebo
    • Eczema Area and Severity Index (EASI)-75
      • An investigator tool used to measure the extent (area) and severity of atopic dermatitis.  EASI-75 is a 75% improvement in this score from the start of the trial.
      • 25.0-33.2% of patients achieved an EASI-75 versus 11.4-12.7% on placebo.
      • 44%-51% of patients achieved an EASI-75 75% improvement in lesion extent and severity (EASI-75) versus 12-15% on placebo.
  • Reductions in daily itch and improved sleep and quality of life were also observed with Dupixent vs placebo.3
    • Patients reported these effects of Dupixent versus placebo within 2 weeks.
  • The majority of patients who saw benefit from Dupixent at 16 weeks maintained their response at 52 weeks with continued Dupixent dosing.4,5

Similar efficacy results (IGA and EASI-75) were observed in the monotherapy adolescent (age 12-17) clinical trial, and in the Dupixent plus topical corticosteroids (TCS) clinical trials for ages 6-11 years, and 6 months–5 years.6,7,8

What Are the Most Common Side Effects of Dupixent?

In clinical trials, the most common side effects reported were conjunctivitis (pink eye), injection site infections and cold sores on the lips and in the mouth.1-7  The clinical trial side effects profile for children through 16 weeks was similar to that of adults with atopic dermatitis.

Are There Other Biologics FDA-Approved for Atopic Dermatitis?

Yes. Both Dupixent and Adbry (tralokinumab-ldrm) are biologics FDA-approved for moderate to severe atopic dermatitis. Dupixent has a different antibody target than Adbry. Learn more about Adbry here. Clinical trials for other biologics for atopic dermatitis are underway.

Head-to-head comparative clinical trials of Dupixent and Adbry are not yet available.

How Long Do I Have to Take Dupixent?

Atopic dermatitis is a chronic skin disease that can affect everyone differently.  The length of therapy with Dupixent should be discussed with your healthcare provider.  Recently published studies have investigated the ‘real-world’ usage of Dupixent.9,10

Can Children Use Dupixent?

Yes. Dupixent is FDA-approved for children ages 6 months and older.

Can I Use Dupixent with Other Prescription Atopic Dermatitis Therapies?

Talk to your health care provider about using Dupixent with other prescription and over the counter therapies for atopic dermatitis. Dupixent can be used in combination with topical corticosteroids (TCS).3,5,7 Be sure your doctor knows all medications you are using for your atopic dermatitis as well as other medical conditions.

How Much Does Dupixent Cost?

The cost for Dupixent depends on your health insurance coverage for prescriptions. Sanofi Genzyme and Regeneron, the companies that make Dupixent, may have programs to help with your copay costs if needed. You can learn more at www.dupixent.com.

How Do I Know if Dupixent is Right for Me?

It’s important to talk to your doctor about how atopic dermatitis affects your skin and other aspects of your life.  Together, you and your healthcare provider can determine if Dupixent is an appropriate treatment option.

How Can I Get Dupixent?

Dupixent is available by prescription only. Talk to your health care provider and visit www.dupixent.com to learn more.

References
  1. Thaçi D, L Simpson E, Deleuran M et al. Efficacy and safety of dupilumab monotherapy in adults with moderate-to-severe atopic dermatitis: a pooled analysis of two phase 3 randomized trials (LIBERTY AD SOLO 1 and LIBERTY AD SOLO 2). J Dermatol Sci. 2019 May;94(2):266-275.
  2. Simpson EL, Bieber T, Guttman-Yassky E et al. Two Phase 3 Trials of Dupilumab versus Placebo in Atopic Dermatitis. N Engl J Med. 2016 Dec 15;375(24):2335-2348.
  3. Blauvelt A, de Bruin-Weller M, Gooderham M et cal. 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 Jun 10;389(10086):2287-2303.
  4. Cork MJ, Eckert L, Simpson EL et al. Dupilumab improves patient-reported symptoms of atopic dermatitis, symptoms of anxiety and depression, and health-related quality of life in moderate-to-severe atopic dermatitis: analysis of pooled data from the randomized trials SOLO 1 and SOLO 2. J Dermatolog Treat. 2020 Sep;31(6):606-614.
  5. Silverberg JI, Yosipovitch G, Simpson EL et al. Dupilumab treatment results in early and sustained improvements in itch in adolescents and adults with moderate to severe atopic dermatitis: Analysis of the randomized phase 3 studies SOLO 1 and SOLO 2, AD ADOL, and CHRONOS. J Am Acad Dermatol. 2020 Jun;82(6):1328-1336.
  6. Simpson EL, Paller AS, Siegfried EC et al. Efficacy and Safety of Dupilumab in Adolescents With Uncontrolled Moderate to Severe Atopic Dermatitis: A Phase 3 Randomized Clinical Trial. JAMA Dermatol. 2020 Jan 1;156(1):44-56.
  7. Paller AS, Siegfried EC, Thaçi D et al. Efficacy and safety of dupilumab with concomitant topical corticosteroids in children 6 to 11 years old with severe atopic dermatitis: A randomized, double-blinded, placebo-controlled phase 3 trial. J Am Acad Dermatol. 2020 Nov;83(5):1282-1293.
  8. Paller AS, Siegfried EC, Simpson EL et al. A phase 2, open-label study of single-dose dupilumab in children aged 6 months to <6 years with severe uncontrolled atopic dermatitis: pharmacokinetics, safety and efficacy. J Eur Acad Dermatol Venereol. 2021 Feb;35(2):464-475. doi: 10.1111/jdv.16928. Epub 2020 Nov 8.
  9. Silverberg JI, Guttman-Yassky E, Gadkari A et al. Real-world persistence with dupilumab among adults with atopic dermatitis. Ann Allergy Asthma Immunol. 2021 Jan;126(1):40-45.
  10. Halling AS, Loft N, Silverberg JI et al. Real-world evidence of dupilumab efficacy and risk of adverse events: A systematic review and meta-analysis. J Am Acad Dermatol. 2021 Jan;84(1):139-147.