Significant Skin Clearance

A total of 251 adolescent patients in Trial 6 (16‑week trial) with moderate‑to‑severe atopic dermatitis not adequately controlled with topical prescription treatments were randomized to DUPIXENT or placebo. Adolescents ≥60 kg received DUPIXENT 300 mg Q2W following a 600 mg loading dose, while adolescents <60 kg received 200 mg Q2W following a 400 mg loading dose. An endpoint included the change from baseline in the proportion of subjects with EASI‑75 at Week 16.1,2

Significant Skin Clearance

At least 75% improvement in lesion extent and severity (EASI‑75) at Week 16 with DUPIXENT in Trial 6 (secondary endpoint)1,2,a,b

Significant skin clearance was demonstrated in adolescents (primary endpoint)1,2,c

  • 24% of DUPIXENT patients achieved clear or almost‑clear skin (IGA 0 or 1) vs 2% with placebo at Week 16 in Trial 6 (primary endpoint; P<0.0001).
  1. FAS includes all subjects randomized.
  2. Subjects who received rescue treatment or with missing data were considered nonresponders (59% and 21% in the placebo and DUPIXENT arms, respectively).
  3. Responder was defined as a subject with an IGA 0 or 1 (clear or almost clear) and a reduction of ≥2 points on a 0‑4 IGA scale at Week 16 (primary efficacy outcome).

Measuring Disease Extent and Severity and Patient‑Reported Symptoms

EASI combines the severity of the signs of eczema and the extent of skin involvement.2

The severity of each of 4 eczema signs is assessed on a scale of 0 to 36

The extent of lesions in each body region is evaluated based on the percentage of involvement and is given a value between 0 and 6. Each body region value is then weighted by a corresponding multiplier; lower extremities are weighted more while head and neck are weighted the least.3,4

Each region gets a total region score: Severity Score x Area Score x Multiplier = Region Score

The final EASI score is the sum of all 4 region scores. The composite score, on a scale from 0 to 72 determines the severity of the signs of eczema and the extent to which the patient is affected.3,4

An improvement of at least 75% in lesion extent and severity (EASI‑75) from baseline is a clinically meaningful change.1

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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.