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Demonstrated Safety in Adults

Three randomized, double-blind, placebo-controlled, multicenter trials (Trial 1, Trial 2, and Trial 3) and one dose-ranging trial (Trial 4) evaluated the safety of DUPIXENT in adults with moderate-to-severe atopic dermatitis. Trials 1, 2, and 4 compared the safety of DUPIXENT monotherapy to placebo through Week 16. Trial 3 compared the safety of DUPIXENT + TCS to placebo + TCS through Week 52.1

Safety data collected from three phase 3 trials and one dose-ranging trial (Trial 4) (N=2304)1,2

  • 49% had allergic rhinitis
  • 37% had food allergy
  • 27% had allergic conjunctivitis

Safety and efficacy of DUPIXENT have not been established in the treatment of these conditions.1

Demonstrated safety across 52 weeks in adults

The Week 52 safety profile of DUPIXENT + TCS in adults was generally consistent with the Week 16 adult safety profile.1

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on Adverse Reactions

Week 16 adverse reactions occurring in ≥1% of adult patients1

Adverse reaction DUPIXENT monotherapya DUPIXENT + TCSb
DUPIXENTc
(n=529)
n (%)		 Placebo
(n=517)
n (%)		 DUPIXENT + TCSc
(n=110)
n (%)		 Placebo + TCS
(n=315)
n (%)
Injection site reaction 51 (10) 28 (5) 11 (10) 18 (6)
Conjunctivitisd 51 (10) 12 (2) 10 (9) 15 (5)
Blepharitis 2 (<1) 1 (<1) 5 (5) 2 (1)
Oral herpes 20 (4) 8 (2) 3 (3) 5 (2)
Keratitise 1 (<1) 0 4 (4) 0
Eye pruritus 3 (1) 1 (<1) 2 (2) 2 (1)
Oral herpes simplex virus infectionf 10 (2) 6 (1) 1 (1) 1 (<1)
Dry eye 1 (<1) 0 2 (2) 1 (<1)
  1. Pooled analysis of Trials 1, 2, and 4 (phase 2 dose-ranging study).
  2. Analysis of Trial 3 in which subjects were on background TCS therapy.
  3. DUPIXENT 600 mg at Week 0, followed by 300 mg every 2 weeks.
  4. Conjunctivitis cluster includes conjunctivitis, allergic conjunctivitis, bacterial conjunctivitis, viral conjunctivitis, giant papillary conjunctivitis, eye irritation, and eye inflammation.
  5. Keratitis cluster includes keratitis, ulcerative keratitis, allergic keratitis, atopic keratoconjunctivitis, and ophthalmic herpes simplex.
  6. Other herpes simplex virus infection cluster includes herpes simplex, genital herpes, herpes simplex otitis externa, and herpes virus infection, but excludes eczema herpeticum.
  • Most patients experiencing conjunctivitis recovered or were recovering during the treatment period1

Select adverse events in the 52-week trial in adults

  • The rate of serious adverse events with DUPIXENT + TCS was comparable to placebo + TCS (4% vs 5%, respectively)2
  • Keratitis was reported in 4% of the DUPIXENT + TCS group and in 0% of the placebo + TCS group1
  • Conjunctivitis was reported in 16% of the DUPIXENT + TCS group and in 9% of the placebo group + TCS group1

Discontinuation rates in adults due to adverse events with DUPIXENT with or without TCS were comparable to those with placebo1,2

  • 1.9% of patients treated with DUPIXENT discontinued treatment through Week 16 vs 1.9% of patients treated with placebo through Week 16 (Trials 1, 2, and 4)
  • Similar discontinuation rates occurred at Week 52 in Trial 3 (1.8% with DUPIXENT + TCS vs 7.6% with placebo + TCS)

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 DUPIXENT1,3

DUPIXENT is not a steroid treatment or an immunosuppressant1

There is no requirement for initial lab testing or ongoing lab monitoring according to the Prescribing Information1

See the Adolescent Safety Profile
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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.
  36. Data on file. Regeneron Pharmaceuticals, Inc.
  37. DUPIXENT Prescribing Information.
  38. Data on file, Regeneron Pharmaceuticals, Inc.
  39. 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.
  40. DUPIXENT Prescribing Information.
  41. 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.
  42. 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.
  43. DUPIXENT Prescribing Information.
  44. DUPIXENT Prescribing Information.
  45. Data on file, Regeneron Pharmaceuticals, Inc.
  46. DUPIXENT Prescribing Information.
  47. Data on file, Regeneron Pharmaceuticals, Inc.
  48. DUPIXENT Prescribing Information.
  49. 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.
  50. DUPIXENT Prescribing Information.
  51. Data on file, Regeneron Pharmaceuticals, Inc.
  52. 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.
  53. DUPIXENT Prescribing Information.
  54. Data on file, Regeneron Pharmaceuticals, Inc.
  55. 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.
  56. 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.
  57. DUPIXENT Prescribing Information.
  58. Data on file, Regeneron Pharmaceuticals, Inc.