The Largest Clinical Development Program in Atopic Dermatitis

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 Q2W or placebo. For all patients in Trial 3, lesions were treated with concomitant TCS.

Three pivotal randomized, double-blind, placebo-controlled studies in adult patients with moderate-to-severe atopic dermatitis not adequately controlled by topical medications1

Study Designs

All studies initiated with two 300 mg DUPIXENT or placebo subcutaneous injections at Week 0

Disease severity was defined by an IGA score ≥3 in the overall assessment of atopic dermatitis lesions on a severity scale of 0 to 4, and EASI score ≥16 on a scale of 0 to 72, and a minimum body surface area involvement of ≥10%.1

QW dosing was also studied in a randomized treatment arm but no additional benefit was seen over Q2W dosing.

Primary Endpoint

  • Change from baseline to Week 16 in the proportion of subjects with an IGA 0 (clear) or 1 (almost clear) and ≥2-point improvement

Other Prespecified Endpoints2

  • Proportion of subjects with EASI-75 (improvement of ≥75% in EASI score from baseline) at Week 16 and 52
  • Reduction in itch as defined by ≥4-point improvement in the peak pruritus NRS from baseline to Weeks 16 and 52
  • Proportion of subjects with EASI-90 (improvement of ≥90% in EASI score from baseline) at Week 16
  • Change from baseline to Week 52 in the proportion of subjects with an IGA 0 (clear) or 1 (almost clear) and ≥2-point improvement
  • Percent change from baseline in EASI score at Weeks 16 and 52

Patients enrolled had uncontrolled atopic dermatitis1,2

Select Baseline Characteristics Across Three Phase 3 Trials Include:

Moderate atopic dermatitis Baseline IGA 3
Severe atopic dermatitis Baseline IGA 4
Baseline mean EASI score

Baseline weekly averaged peak pruritus NRS
Mean age
Mean duration of disease
Mean body surface area
involvement

QW, once every week; Q2W, once every 2 weeks.

  1. Emollient background regimen/therapy was required.
  2. As needed, subjects received topical calcineurin inhibitors for problem areas only, such as the face, neck, and intertriginous and genital areas for 52 weeks.
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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.