FAQ – Dupilumab (Dupixent)

What is dupilumab?

Dupilumab (Dupixent) is a biologic drug approved by the FDA for adults and children (6yrs and up) with moderate to severe atopic dermatitis.  The FDA approved dupilumab for adults in March 2017, for children ages 12-17 in March 2019, and for ages 6-11 in May 2020.  

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 dupilumab is an appropriate treatment option.  

What is a biologic drug?

Biologic drugs or “biologics” are genetically engineered from proteins derived from living cells or tissues. 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 dupilumab work?

Dupilumab 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.  

By inhibiting IL-4 and IL-13 from binding to its receptors (through blockade of the shared IL-4 receptor alpha), dupilumab inhibits these key components of the immune system’s over-reaction that can result in atopic dermatitis. A calmer immune system leads to fewer and/or less severe signs and symptoms of AD.

How do you take dupilumab?

For adults, dupilumab is taken as a 300mg subcutaneous (s.c.) injection (injection under the skin) once every other week following an initial s.c. 600 mg dose.  For children ages 6-17 years, dupilumab has a weight-tiered dosing regimen that includes an initial dose followed by either every other week or once monthly dosing.  

Like many biologics, dupilumab 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 dupilumab to bind to its target, making the drug ineffective.

How effective is dupilumab for atopic dermatitis? 

In the LIBERTY AD SOLO 1 and 2 monotherapy adult clinical trials for dupilumab (i.e. dupilumab used as a single therapy taken every other week), after 16 weeks on dupilumab1,2:

  • 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 dupilumab vs placebo.3   
    • Patients reported these effects of dupilumab versus placebo within 2 weeks. 
  • The majority of patients who saw benefit from dupilumab at 16 weeks maintained their response at 52 weeks with continued dupilumab dosing.4,5  

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

What are the side effects of dupilumab?

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?

No. Clinical trials for other biologics for atopic dermatitis are underway.

How long do I have to take dupilumab?

Dupilumab is best used continuously.  Intermittent (on/off) use could lead to your own immune system recognizing a biologic therapy, like dupilumab, as foreign (i.e. produce antibodies against it) making it not work as well.  As atopic dermatitis is a chronic skin disease, discuss any concerns you have regarding longer-term use with your healthcare provider.   Recently published studies have investigated the ‘real-world’ usage of dupilumab.8,9

Can children use dupilumab?

Yes.  Dupilumab is FDA-approved for children ages 6 years and older.  Clinical trials are underway for children ages ≥6 months.  

How much does dupilumab cost?

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

How do I know if dupilumab 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 dupilumab is an appropriate treatment option.  

How can I get dupilumab?

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

Can I use dupilumab with other prescription atopic dermatitis therapies?

Talk to your health care provider about using dupilumab with other prescription and over the counter therapies for atopic dermatitis.  Dupilumab has been used and studied in clinical trials 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.  

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1Thaçi 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.

2Simpson 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. 

3Blauvelt 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. 

4Cork 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.

5Silverberg 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.

6Simpson 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.

7Paller 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.

8Silverberg 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. 

9Halling 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.

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