Demonstrated Safety

Three randomized, double-blind, placebo-controlled, multicenter trials (SOLO 1, SOLO 2, and CHRONOS [Trials 1,2 and 3, respectively]) and one dose-ranging trial (Trial 4) evaluated the safety of DUPIXENT in subjects 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

  • 48% had asthma
  • 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

Adverse Reactions Occurring in ≥1% of Patients Through Week 161

The table summarizes the adverse reactions that occurred at a rate of at least 1% in the DUPIXENT 300 mg Q2W monotherapy groups, and in the DUPIXENT + TCS group, all at a higher rate than in their respective comparator groups during the first 16 weeks of treatment.1

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on Adverse Reactions

Adverse reaction DUPIXENT monotherapya DUPIXENT + TCSb
DUPIXENTc
(n=529)
n (%)
Placebo
(n=517)
n (%)
DUPIXENTc
(n=110)
n (%)
Placebo
(n=315)
n (%)
Injection site reactions 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 two 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.
  • Discontinuation rates due to adverse events at Week 16 were 1.9% in both the DUPIXENT 300 mg Q2W and placebo groups (Trials 1, 2, and 4).1

The safety profile of DUPIXENT + TCS through Week 52 was generally consistent with the safety profile observed at Week 161

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.
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Reference:
References:
  1. DUPIXENT Prescribing Information. March 2017.
  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. March 2017.
  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. March 2017.
  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. March 2017.
  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. March 2017.
  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. March 2017.
  25. Data on file, Regeneron Pharmaceuticals, Inc.
  26. DUPIXENT Prescribing Information. March 2017.
  27. Data on file, Regeneron Pharmaceuticals, Inc.
  28. DUPIXENT Prescribing Information. March 2017.
  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. March 2017.
  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. March 2017.