1. Home
  2. Efficacy and Safety
  3. Safety Profile

Demonstrated Safety

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

The Week 52 safety profile of DUPIXENT + TCS was generally consistent with the Week 16 safety profile with adverse reactions occurring in ≥1% of patients.1

Swipe left for more information
on Adverse Reactions

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

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 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.
  • Conjunctivitis was the most frequently reported eye disorder1

— Most cases recovered or were recovered during the treatment period

Select adverse events in the 52-week trial

  • 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 due to adverse events with DUPIXENT with or without TCS were comparable to those on placebo1

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

DUPIXENT is not an immunosuppressant1

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

Getting Started Thinking about prescribing
DUPIXENT? Find the information you
need to get started. Start Now
Connect With a Rep Have questions about DUPIXENT? Get
answers from a representative. Request a Visit
DUPIXENT MyWay Get information about DUPIXENT
MyWay, a program with personalized
nursing and coverage support. Explore Resources
  1. EASI, Eczema Area and Severity Index; IGA, Investigator’s Global Assessment; NRS, numerical rating scale; Q2W, once every 2 weeks; TCS, topical corticosteroids.

Reference:
References:
  1. DUPIXENT Prescribing Information. October 2018.
  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. October 2018.
  7. Wei W, Anderson P, Gadkari A, et al. Extent and consequences of inadequate disease control among adults with atopic dermatitis. J Dermatol. 2018;45(2):150-157.
  8. DUPIXENT Prescribing Information. October 2018.
  9. DUPIXENT Prescribing Information. October 2018.
  10. 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.
  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. EASI User Guide. HOME—Harmonising Outcome Measures for Eczema website. http://www.homeforeczema.org/documents/easi-user-guide-jan-2017-v3.pdf. Accessed July 11, 2018.
  15. DUPIXENT Prescribing Information. October 2018.
  16. Data on file, Regeneron Pharmaceuticals, Inc.
  17. 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.
  18. 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.
  19. DUPIXENT Prescribing Information. October 2018.
  20. Data on file, Regeneron Pharmaceuticals, Inc.
  21. 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.
  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. 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.
  24. DUPIXENT Prescribing Information. October 2018.
  25. Data on file, Regeneron Pharmaceuticals, Inc.
  26. DUPIXENT Prescribing Information. October 2018.
  27. Data on file, Regeneron Pharmaceuticals, Inc.
  28. DUPIXENT Prescribing Information. October 2018.
  29. 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 Immunol Pract. 2017;5(6):1519-1531.
  31. Data on file, Regeneron Pharmaceuticals, Inc.
  32. 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.
  33. DUPIXENT Prescribing Information. October 2018.
  34. 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.
  36. DUPIXENT Prescribing Information. October 2018.