When Topical Rx Therapies Are Not Enough...
Fast Itch Relief that Lasts

In 3 pivotal trials, adult patients with moderate-to-severe atopic dermatitis not adequately controlled with topical prescription treatments were randomized to DUPIXENT 300 mg Q2W or placebo. In Trial 3, concomitant TCS was used. An endpoint included the reduction in itch from baseline to Week 16 (all trials) and 52 (Trial 3), as defined by ≥4-point improvement in the Peak Pruritus numerical rating scale (NRS).1-3

Significant Itch Relief

Significant itch reduction (Peak Pruritus NRS) at Week 2 and Week 16 with DUPIXENT in Trial 1 (secondary endpoint)1,4,5,a,b
Trial 1: Monotherapy at 16 Weeks
  • 36% of adult patients with DUPIXENT (n=225) achieved ≥4‑point reduction in Peak Pruritus NRS score vs 10% with placebo at Week 16 in Trial 2 (n=221; P<0.001)1,5

Adult patients experienced a ≥4-point reduction in itch after the first dose as measured at Week 2 (≈9% vs ≈3%)1,4

  1. Subjects who received rescue treatment or with missing data were considered nonresponders.
  2. Full Analysis Set (FAS) includes all subjects randomized.

Sustained itch relief

Sustained itch reduction (Peak Pruritus NRS) at 1 year with DUPIXENT + TCS in Trial 3 (secondary endpoint)2,4,a-c

Trial 3: Concomitant Therapy With TCS

Long-term itch reduction up to 52 weeks2

  1. Subjects who received rescue treatment or with missing data were considered nonresponders.
  2. FAS includes all subjects randomized.
  3. In Trial 3, as needed, subjects received topical calcineurin inhibitors for problem areas only, such as the face, neck, and intertriginous and genital areas.
  4. Week 52 data were limited to patients completing 52 weeks as of the cutoff date.

Pruritus NRS assesses the average itch intensity over the previous 24 hours3

A patient-reported measure that uses a 0- to 10-point scale, with which patients are asked3:


“On a scale of 0 to 10, how would you rate your itch overall (on average) during the previous 24 hours?”

None
The Worst
Imaginable

A reduction of at least 4 points in pruritus NRS from baseline is a clinically meaningful change.1

EASI, Eczema Area and Severity Index; NRS, numerical rating scale.

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EASI, Eczema Area and Surface Index; IGA, Investigator’s Global Assessment; NRS, numerical rating scale; Q2W, once every 2 weeks; TCS, topical corticosteroids.

Reference:
References:
  1. DUPIXENT Prescribing Information.
  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. 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. Lancet. 2017;389(10086):2287‑2303.
  4. Data on file, Regeneron Pharmaceuticals, Inc.
  5. 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.
  6. DUPIXENT Prescribing Information.
  7. Wei W, Anderson P, Gadkari A, et al. Extent and consequences of inadequate disease control among adults with a history of moderate‑to‑severe atopic dermatitis. J Dermatol. 2018;45(2):150‑157.
  8. DUPIXENT Prescribing Information.
  9. DUPIXENT Prescribing Information.
  10. Hanifin JM, Thurston M, Omoto M, Cherill R, Tofte SJ, Graeber M; the EASI Evaluator Group. The eczema area and severity index (EASI): assessment of reliability in atopic dermatitis. Exp Dermatol. 2001;10(1):11‑18.
  11. Data on file, Regeneron Pharmaceuticals, Inc.
  12. 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. Lancet. 2017;389(10086):2287‑2303.
  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. Blauvelt A, Rosmarin D, Bieber T, et al. Improvement of atopic dermatitis with dupilumab occurs equally well across different anatomic regions: data from phase 3 clinical trials [published online February 4, 2019]. Br J Dermatol. doi:10.1111/bjd.17703
  15. EASI User Guide. HOME‑Harmonising Outcome Measures for Eczema website. http://www.homeforeczema.org/documents/easi-user-guide-jan-2017-v3.pdf. Accessed January 4, 2019.
  16. DUPIXENT Prescribing Information.
  17. Data on file, Regeneron Pharmaceuticals, Inc.
  18. 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. Lancet. 2017;389(10086):2287‑2303.
  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.
  21. 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. Lancet. 2017;389(10086):2287‑2303.
  22. 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.
  23. Data on file, Regeneron Pharmaceuticals, Inc.
  24. 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.
  25. Blauvelt A, de Bruin‑Weller M, Szepietowski JC, et al. Efficacy and safety of dupilumab with concomitant topical corticosteroids in moderate‑to‑severe atopic dermatitis over 1‑year as assessed by baseline characteristics. Presented at: 26th European Academy of Dermatology and Venereology Congress; September 13‑17, 2017; Geneva, Switzerland.
  26. Pariser DM, Lockshin BN, Griffiths CEM. Dupilumab and concomitant topical corticosteroids in the long‑term management of moderate‑to‑severe atopic dermatitis: analysis of clinical outcomes by race (LIBERTY AD CHRONOS). Presented at: 10th Annual Skin of Color Seminar Series; May 5‑6, 2018; New York, New York.
  27. DUPIXENT Prescribing Information.
  28. Data on file, Regeneron Pharmaceuticals, Inc.
  29. DUPIXENT Prescribing Information.
  30. Data on file, Regeneron Pharmaceuticals, Inc.
  31. Blauvelt A, Simpson EL, Tyring SK, et al. Dupilumab does not affect correlates of vaccine‑induced immunity: a randomised, placebo‑controlled trial in adults with moderate‑to‑severe atopic dermatitis. J Am Acad Dermatol. 2019;80(1):158‑167.
  32. DUPIXENT Prescribing Information.
  33. Boguniewicz M, Alexis AF, Beck LA, et al. Expert perspectives on management of moderate‑to‑severe atopic dermatitis: a multidisciplinary consensus addressing current and emerging therapies. J Allergy Clin Immumol Pract. 2017;5(6):1519‑1531.
  34. DUPIXENT Prescribing Information.
  35. Data on file. Regeneron Pharmaceuticals, Inc.
  36. DUPIXENT Prescribing Information.
  37. Data on file, Regeneron Pharmaceuticals, Inc.
  38. 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. Lancet. 2017;389(10086):2287‑2303.
  39. DUPIXENT Prescribing Information.
  40. Gandhi NA, Bennett BL, Graham NMH, Pirozzi G, Stahl N, Yancopoulos GD. Targeting key proximal drivers of type 2 inflammation in disease. Nat Rev Drug Discov. 2016;15(1):35‑50.
  41. 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(3):1420‑1432.
  42. DUPIXENT Prescribing Information.
  43. DUPIXENT Prescribing Information.
  44. Data on file, Regeneron Pharmaceuticals, Inc.
  45. DUPIXENT Prescribing Information.
  46. Data on file, Regeneron Pharmaceuticals, Inc.
  47. DUPIXENT Prescribing Information.
  48. Blauvelt A, Simpson EL, Tyring SK, et al. Dupilumab does not affect correlates of vaccine‑induced immunity: a randomised, placebo‑controlled trial in adults with moderate‑to‑severe atopic dermatitis. J Am Acad Dermatol. 2019;80(1):158‑167.
  49. DUPIXENT Prescribing Information.
  50. Data on file, Regeneron Pharmaceuticals, Inc.
  51. 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.
  52. DUPIXENT Prescribing Information.
  53. Data on file, Regeneron Pharmaceuticals, Inc.
  54. Hanifin JM, Thurston M, Omoto M, Cherill R, Tofte SJ, Graeber M; the EASI evaluator group. The eczema area and severity (EASI): assessment of reliability in atopic dermatitis. Exp Dermatol. 2001;10(1):11‑18.
  55. EASI User Guide. HOME–Harmonising Outcome Measures for Eczema website. http://www.homeforeczema.org/documents/easi-user-guide-jan-2017-v3.pdf. Accessed January 4, 2019.
  56. DUPIXENT Prescribing Information.
  57. Data on file, Regeneron Pharmaceuticals, Inc.