The Largest Clinical Development Program in Atopic Dermatitis

DUPIXENT was evaluated in adult patients whose moderate-to-severe atopic dermatitis was inadequately controlled on topical therapies.1,2

3

pivotal trials

≥2100

patients

52%

moderate disease

≈28 years

mean disease duration

Clinical trials included monotherapy (Trials 1 and 2) and with concomitant TCS (Trial 3); all trials initiated with two 300 mg DUPIXENT or placebo subcutaneous injections at Week 0, and emollient background regimen was required.1,2

Select baseline characteristics across 3 clinical studies1,2

Skin severity at baseline

52%

Moderate atopic
dermatitis (IGA 3)

48%

Severe atopic
dermatitis (IGA 4)

Not actual patients. For illustrative purposes only.

Disease extent at baseline

33 Mean EASI score out of 72

≈55% Mean body surface area involvement

Itch severity at baseline
(peak pruritus NRS)b

7 on a scale of 0 to 10

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, an EASI score ≥16 on a scale of 0 to 72, and a minimum body surface area involvement of ≥10%.1

Primary endpoint across all 3 pivotal trials: Change from baseline to Week 16 in the proportion of subjects with an IGA 0 (clear) or 1 (almost clear) and a ≥2-point improvement1

EASI, Eczema Area and Surface Index: IGA, Investigator’s Global Assessment; NRS, numerical rating scale; TCS, topical corticosteroids.

a Mean age of patients across all 3 trials was approximately 38 years.

b Weekly averaged peak pruritis NRS score (10 indicates the most severe).

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  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.
  30. Data on file, Regeneron Pharmaceuticals, Inc.
  31. 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.
  32. DUPIXENT Prescribing Information. October 2018.
  33. 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.
  34. DUPIXENT Prescribing Information. October 2018.