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Study Designs

A total of 917 adult patients in Trials 1 and 2 (16-week trials) and 421 adult patients in Trial 3 (52-week trial) with moderate-to-severe atopic dermatitis not adequately controlled with topical treatments were randomized to DUPIXENT 300 mg Q2W or placebo. For all patients in Trial 3, lesions were treated with concomitant topical corticosteroids (TCS). Eligible patients had an IGA score ≥3 (overall atopic dermatitis lesion severity scale of 0 to 4), EASI score ≥16 on a scale of 0 to 72, and body surface area involvement of ≥10%. At baseline, 52% of subjects had an IGA score of 3 (moderate atopic dermatitis), 48% of subjects had an IGA of 4 (severe atopic dermatitis), mean EASI score was 33 and weekly averaged peak pruritus NRS was 7 on a scale of 0 to 10. The primary endpoint for all three trials was the change from baseline in the proportion of subjects with an IGA 0 (clear) or 1 (almost clear) and ≥2-point improvement at Week 16. Other endpoints included the change from baseline in the proportion of subjects with EASI-75 (improvement of ≥75%) and reduction in itch as defined by ≥4-point improvement in the peak pruritus NRS.1

IGA Efficacy Results

Significantly Clearer Skin

38% and 36% of DUPIXENT patientsa in 2 pivotal studies (Trials 1 and 2) achieved clear or almost-clear skin (IGA 0 or 1) at Week 16 vs 10% and 9% with placeboa (P<0.001)1,2,b

39% and 36% of DUPIXENT patientsa achieved clear or almost-clear skin with DUPIXENT + TCSa at 16 weeks and 52 weeks vs 12% and 13% with placebo + TCS, respectively in Trial 3 (P<0.0001)1,3,b

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EASI Efficacy Results

Significant Improvement in Disease Extent and Severity

51% and 44% of patients treated with DUPIXENTa experienced at least 75% improvement in EASI (EASI-75) in 2 pivotal studies (Trials 1 and 2) at Week 16 vs 15% and 12% with placebo (P<0.001). Similar results were seen in Trial 3 (concomitant use with TCS)1,2,a

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Pruritus NRS Efficacy Results

Rapid and Sustained Itch Reduction

51% of patients experienced long-term itch reduction (≥4-point improvement on the peak pruritus NRS) at Week 52 with DUPIXENT + TCSa vs 13% with placebo + TCSa (P<0.0001) in Trial 3. Significant reduction of itch occurred as early as Week 21,3

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Safety Results

Demonstrated Safety Profile1

The most common adverse reactions (incidence ≥1%) are injection site reactions, conjunctivitis, blepharitis, oral herpes, keratitis, eye pruritus, other herpes simplex virus infection, and dry eye.1

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EASI, Eczema Area and Severity Index; IGA, Investigator's Global Assessment; NRS, numerical rating scale; QW, once every week; Q2W, once every 2 weeks; TCS, topical corticosteroids.

  1. Emollient background regimen/therapy was required.
  2. Responder was defined as a subject with IGA 0 or 1 (clear or almost clear) with a reduction of ≥2 points on a 0-4 IGA scale at Week 16 in all trials (primary efficacy outcome) and at Week 52 in CHRONOS (other endpoint).
 

Getting Started

Do you have adult patients with uncontrolled moderate-to-severe atopic dermatitis who are ready for a chance at continuous control?

  • Healthcare providers provide proper training to patients and/or caregivers on the preparation and administration of DUPIXENT prior to use according to the Instructions for Use and full Prescribing Information.
  • After training has been provided by a healthcare provider, patients may self-inject DUPIXENT, or a caregiver may administer DUPIXENT.
See Dosing and Administration

Treating Patients

DUPIXENT may be an appropriate treatment for your adult patients with uncontrolled moderate-to-severe atopic dermatitis.

Identify Appropriate Patients
 

DUPIXENT MyWay®

Get information about DUPIXENT MyWay, a patient support program with personalized nursing and coverage support.

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Explore Resources cEligible patients subject to program restrictions available here.
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. Data on file, Regeneron Pharmaceuticals, Inc.
  4. DUPIXENT Prescribing Information. October 2018.
  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. October 2018.
  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. October 2018.
  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. October 2018.
  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. 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. 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. October 2018.
  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. October 2018.