Questions About DUPIXENT

Have a question about DUPIXENT? See below for commonly asked questions regarding DUPIXENT. If you do not find the answers you're looking for, request a rep or contact us.

DUPIXENT Basics

How can an uncontrolled moderate-to-severe atopic dermatitis patient be defined for DUPIXENT?

Per the indication for DUPIXENT, adult patients with moderate-to-severe atopic dermatitis are considered uncontrolled when their disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.1

How quickly did patients experience itch relief?

  • Itch reduction was evaluated as another endpoint in 3 randomized, double-blind, placebo-controlled trials that enrolled 2119 subjects, 18 years of age and older with moderate-to-severe atopic dermatitis not adequately controlled by topical medication(s). Click here for additional clinical trial design information.

Itch reduction with DUPIXENT was rapid and sustained.1

Significant pruritus relief with DUPIXENT vs placebo was seen as early as Week 2 in both pivotal monotherapy trials with a significant reduction in itch at Week 16.1

  • 41% of patients achieved a ≥4-point improvement in the Pruritus Numerical Rating Scale (NRS) with DUPIXENT at Week 16 in SOLO 1 vs 12% with placebo1
  • 36% of patients achieved a ≥4-point improvement in the Pruritus NRS with DUPIXENT at Week 16 in SOLO 2 vs 10% with placebo1

In addition, in Trial 3:

  • 59% of patients achieved a ≥4-point improvement in the Pruritus Numerical Rating Scale (NRS) with DUPIXENT + TCS at Week 16 vs. 20% in placebo + TCS.1
  • 51% of patients experienced rapid and sustained itch reduction through 52 weeks with DUPIXENT + TCS in the CHRONOS trial vs 13% with placebo + TCS.2

For more details about itch relief with DUPIXENT, please visit the Pruritus NRS Results section of this website.

Clinical Trials

Are there any patients who have been treated with DUPIXENT for up to one year?

CHRONOS was a 52-week pivotal clinical trial evaluating the efficacy and safety of DUPIXENT in patients with uncontrolled, moderate-to-severe atopic dermatitis. The 421 adult patients in CHRONOS were randomized to DUPIXENT + concomitant TCS or placebo + TCS.1

Disease severity was defined by an IGA score ≥3 in the overall assessment of atopic dermatitis lesions on a severity scale of 0 to 4, an EASI score ≥16 on a scale of 0 to 72, and a minimum body surface area involvement of ≥10%.1

Study results demonstrated significant improvement with DUPIXENT + TCS in achieving clear (IGA 0) or almost clear skin (IGA 1) (the primary endpoint at 16 weeks) and lesion extent and severity (EASI) at Week 16 and 52 vs placebo + TCS.1,2

  • 39% of patients treated with DUPIXENT + TCS achieved clear or almost-clear skin at 16 weeks vs 12% with placebo + TCS (P<0.0001)1,2
  • 36% of patients achieved clear or almost-clear skin (IGA 0 or 1) with DUPIXENT + TCS at 52 weeks vs 13% with placebo + TCS in CHRONOS (P<0.0001)1,2
  • 69% and 65% of patients treated with DUPIXENT + TCS demonstrated improvement in EASI-75 at 16 weeks and 52 weeks, respectively, vs 23% and 22% with placebo + TCS (P<0.0001)1,2
  • On average, 85% of patients experienced a mean improvement in EASI score from baseline with DUPIXENT + TCS vs 61% with placebo + TCS (P=0.0015)1,2

The most common adverse reactions (incidence ≥1%) are injection site reactions, conjunctivitis, blepharitis, oral herpes, keratitis, eye pruritus, other herpes simplex virus infection, and dry eye.1

Additionally, the safety profile of DUPIXENT + TCS through Week 52 was generally consistent with the safety profile observed at Week 16.1

In the 52-week trial1:

  • Keratitis was reported in 4% of the DUPIXENT + TCS group and in 0% of the placebo + TCS group
  • Conjunctivitis was reported in 16% of the DUPIXENT + TCS group and in 9% of the placebo + TCS group
  • Discontinuation rates due to adverse events were 1.8% in the DUPIXENT + TCS group and 7.6% in the placebo + TCS group

With 52-week data, does that mean I can stop treatment after a year?

Since atopic dermatitis is a chronic disease, you should evaluate your patients often and consider making any changes to their treatment regimen based on your clinical judgment.

Using DUPIXENT

Does DUPIXENT have to be used concomitantly with TCS?

DUPIXENT can be used with or without TCS. Do not discontinue systemic, topical, or inhaled corticosteroids abruptly upon initiation with DUPIXENT. Reductions in corticosteroid dose, if appropriate, should be gradual and performed under the direct supervision of a physician. Reduction in corticosteroid dose may be associated with systemic withdrawal symptoms and/or unmask conditions previously suppressed by systemic corticosteroid therapy.

The 52-week CHRONOS study was designed to evaluate therapy with DUPIXENT in combination with TCS at week 16 and long-term efficacy and safety at week 52.1,2

The safety profile of DUPIXENT + TCS through Week 52 is generally consistent with the safety profile observed at week 16.1

In the 52-week trial1:

  • Keratitis was reported in 4% of the DUPIXENT + TCS group and in 0% of the placebo + TCS group
  • Conjunctivitis was reported in 16% of the DUPIXENT + TCS group and in 9% of the placebo + TCS group
  • Discontinuation rates due to adverse events were 1.8% in the DUPIXENT + TCS group and 7.6% in the placebo + TCS group

In the 1-year placebo controlled trial in subjects with atopic dermatitis (Trial 3), cardiovascular thromboembolic events (cardiovascular deaths, non-fatal myocardial infarctions, and non-fatal strokes) were reported in 1 (0.9%) of the DUPIXENT + TCS 300 mg Q2W group, 0 (0.0%) of the DUPIXENT + TCS 300 mg QW group, and 1 (0.3%) of the placebo + TCS group.

The most common adverse reactions (incidence ≥1%) in atopic dermatitis patients are injection site reactions, conjunctivitis, blepharitis, oral herpes, keratitis, eye pruritus, other herpes simplex virus infection, and dry eye.

Can DUPIXENT be used concomitantly with TCI?

Yes, DUPIXENT can be used concomitantly with topical calcineurin inhibitors but, as stated in the DUPIXENT label, they should be reserved for problem areas only, such as the face, neck, intertriginous and genital areas. In Trial 3, patients were permitted to use topical calcineurin inhibitors as needed.2

In the 52-week CHRONOS trial, patients were permitted to use topical calcineurin inhibitors as needed for problem areas only.1

For more details about DUPIXENT concomitant usage and dosing, please visit the Getting Started section of this website.

Can my patients stop topical medication use with DUPIXENT?

Because DUPIXENT may be used with or without topical medications, continuing with or stopping concomitant use is at your discretion based on your patient's condition. Do not discontinue systemic, topical, or inhaled corticosteroids abruptly upon initiation with DUPIXENT. Reductions in corticosteroid dose, if appropriate, should be gradual and performed under the direct supervision of a physician. Reduction in corticosteroid dose may be associated with systemic withdrawal symptoms and/or unmask conditions previously suppressed by systemic corticosteroid therapy.

If my patients discontinue use, how long before their symptoms of disease recur?

Atopic dermatitis is a chronic disease, and you may consider treating continuously with DUPIXENT based on your clinical judgment. Individual patient responses may vary.

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Reference:
References:
  1. DUPIXENT Prescribing Information. October 2018.
  2. Simpson EL, Bieber T, Guttman-Yassky E, et al; SOLO 1 and SOLO 2 Investigators. Two phase 3 trials of dupilumab versus placebo in atopic dermatitis. N Engl J Med. 2016;375(24):2335-2348.
  3. Data on file, Regeneron Pharmaceuticals, Inc.
  4. DUPIXENT Prescribing Information. October 2018.
  5. Data on file, Regeneron Pharmaceuticals, Inc.
  6. Simpson EL, Bieber T, Guttman-Yassky E, et al; SOLO 1 and SOLO 2 Investigators. Two phase 3 trials of dupilumab versus placebo in atopic dermatitis. N Engl J Med. 2016;375(24):2335-2348.
  7. Gittler JK, Shemer A, Suárez-Fariñas M, et al. Progressive activation of TH2/TH22 cytokines and selective epidermal proteins characterizes acute and chronic atopic dermatitis. J Allergy Clin Immunol. 2012;130(6):1344-1354.
  8. Brandt EB, Sivaprasad U. Th2 cytokines and atopic dermatitis. J Clin Cell Immunol. 2011;2(3):1-25. doi:10.4172/2155-9899:100011
  9. Noda S, Krueger JG, Guttman-Yassky E. The translational revolution and use of biologics in patients with inflammatory skin diseases. J Allergy Clin Immunol. 2015;135(2):324-336.
  10. Guttman-Yassky E, Nograles KE, Krueger JG. Contrasting pathogenesis of atopic dermatitis and psoriasis—part II: immune cell subsets and therapeutic concepts. J Allergy Clin Immunol. 2011;127(6):1420-1432.
  11. Guttman-Yassky E, Dhingra N, Leung DY. New era of biological therapeutics in atopic dermatitis. Expert Opin Biol Ther. 2013;13(4):549-561.
  12. Data on file, Regeneron Pharmaceuticals, Inc.
  13. Simpson EL, Bieber T, Guttman-Yassky E, et al; SOLO 1 and SOLO 2 Investigators. Two phase 3 trials of dupilumab versus placebo in atopic dermatitis. N Engl J Med. 2016;375(24):2335-2348.
  14. Leshem YA, Hajar T, Hanifin JM, Simpson EL. What the Eczema Area and Severity Index score tells us about the severity of atopic dermatitis: an interpretability study. Br J Dermatol. 2015;172(5):1353-1357.
  15. DUPIXENT Prescribing Information. October 2018.
  16. Blauvelt A, de Bruin-Weller M, Gooderham M, et al. 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 [published May 4, 2017]. Lancet. 2017;389(10086):2287-2303.
  17. DUPIXENT Prescribing Information. October 2018.
  18. Data on file, Regeneron Pharmaceuticals, Inc.
  19. Simpson EL, Bieber T, Guttman-Yassky E, et al; SOLO 1 and SOLO 2 Investigators. Two phase 3 trials of dupilumab versus placebo in atopic dermatitis. N Engl J Med. 2016;375(24):2335-2348.
  20. DUPIXENT Prescribing Information. October 2018.
  21. Data on file, Regeneron Pharmaceuticals, Inc.
  22. Simpson EL, Bieber T, Guttman-Yassky E, et al; SOLO 1 and SOLO 2 Investigators. Two phase 3 trials of dupilumab versus placebo in atopic dermatitis. N Engl J Med. 2016;375(24):2335-2348.
  23. Phan NQ, Blome C, Fritz F, et al. Assessment of pruritus intensity: prospective study on validity and reliability of the visual analogue scale, numerical rating scale and verbal rating scale in 471 patients with chronic pruritus. Acta Derm Venereol. 2012;92(5):502-507.
  24. DUPIXENT Prescribing Information. October 2018.
  25. Data on file, Regeneron Pharmaceuticals, Inc.
  26. DUPIXENT Prescribing Information. October 2018.
  27. Data on file, Regeneron Pharmaceuticals, Inc.
  28. DUPIXENT Prescribing Information. October 2018.
  29. Data on file, Regeneron Pharmaceuticals, Inc.
  30. Leshem YA, Hajar T, Hanifin JM, Simpson EL. What the Eczema Area and Severity Index score tells us about the severity of atopic dermatitis: an interpretability study. Br J Dermatol. 2015;172(5):1353-1357.
  31. EASI User Guide. HOME—Harmonising Outcome Measures for Eczema website. http://www.homeforeczema.org/documents/easi-user-guide-jan-2017-v3.pdf. Accessed January 11, 2017.
  32. Phan NQ, Blome C, Fritz F, et al. Assessment of pruritus intensity: prospective study on validity and reliability of the visual analogue scale, numerical rating scale and verbal rating scale in 471 patients with chronic pruritus. Acta Derm Venereol. 2012;92(5):502-507.
  33. Hanifin JM, Thurston M, Omoto M, Cherill R, Tofte SJ, Graeber M. The eczema area and severity index (EASI): assessment of reliability in atopic dermatitis. Exp Dermatol. 2001;10(1):11-18.
  34. DUPIXENT Prescribing Information. October 2018.
  35. Data on file, Regeneron Pharmaceuticals, Inc.
  36. Torrelo A, Ortiz J, Alomar A, Ros S, Pedrosa E, Cuervo J. Health-related quality of life, patient satisfaction, and adherence to treatment in patients with moderate or severe atopic dermatitis on maintenance therapy: the CONDA-SAT study. Actas Dermosifiliogr. 2013;104(5):409-417.
  37. Simpson EL, Bieber T, Guttman-Yassky E, et al; SOLO 1 and SOLO 2 Investigators. Two phase 3 trials of dupilumab versus placebo in atopic dermatitis. N Engl J Med. 2016;375(24):2335-2348.
  38. DUPIXENT Prescribing Information. October 2018.