Safety Consistent in Adolescents and Adults1

The safety profile of DUPIXENT in patients aged 12 to 17 years through Week 16 was similar to the safety profile from studies in adults with atopic dermatitis.

  • The most common adverse reactions (incidence ≥1% at Week 16) in adult patients with atopic dermatitis are injection site reactions, conjunctivitis, blepharitis, oral herpes, keratitis, eye pruritus, other herpes simplex virus infection, and dry eye.2

Long‑term Safety in Adolescents

The long‑term safety of DUPIXENT in adolescents was assessed in an open‑label extension trial (Trial 7) through Week 522

  • The safety profile at Week 52 was similar to the safety profile observed at Week 16 in Trial 6 (adolescent trial) and in all 3 adult trials
  • The long‑term safety profile in adolescents was consistent with that seen in adults

Discontinuation rates in adolescents due to adverse events with DUPIXENT were comparable to those with placebo1

Trial 6
0%
of adolescent patients treated with DUPIXENT discontinued treatment through Week 16
1.2%
of adolescent patients treated with placebo discontinued through Week 16

Patients should discontinue DUPIXENT if a clinically significant hypersensitivity reaction occurs and/or until a parasitic (helminth) infection resolves in a patient who does not respond to anti-helminth treatment.

Avoid use of live vaccines with DUPIXENT2

DUPIXENT is not a steroid treatment or an immunosuppressant2

There is no requirement for initial lab testing or ongoing lab monitoring according to the Prescribing Information2

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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.