When Topical Rx Therapies Are Not Enough…
Improvement in Disease Extent and Severity

In 3 pivotal trials, adult patients with moderate-to-severe atopic dermatitis not adequately controlled with topical prescription treatments were randomized to DUPIXENT 300 mg Q2W or placebo. In Trial 3, concomitant TCS was used. An endpoint measured included the proportion of subjects with EASI-75 (improvement of ≥75% in Eczema Area and Severity Index [EASI] score from baseline).1,2

Significantly Clearer Skin

Sustained at least 75% improvement in lesion extent and severity (EASI-75) up to 52 weeks with DUPIXENT + TCS in Trial 3 (secondary endpoint)3,4,a,b

Trial 3: Concomitant Therapy With TCS

Patients achieved significantly more improvement in lesion extent and severity across monotherapy trials at Week 16 (secondary endpoint).1

  • 51% and 44% of DUPIXENT patients achieved at least a 75% improvement in lesion extent and severity (EASI-75) vs 15% and 12% with placebo at 16 weeks in Trials 1 and 2, respectively (P<0.001)1,5

In a post hoc analysis of Trial 3, patients treated with DUPIXENT + TCS had consistent improvements in lesion extent and severity across the head and neck, upper extremities, trunk, and lower extremities6

  1. Subjects who received rescue treatment or with missing data were considered nonresponders.
  2. FAS includes all subjects randomized.
  3. Week 52 data were limited to patients completing 52 weeks as of the cutoff date.

Measuring Disease Extent and Severity and Patient-Reported Symptoms

EASI combines the severity of the signs of eczema and the extent of skin involvement.2

The severity of each of 4 eczema signs is assessed on a scale of 0 to 37

The extent of lesions in each body region is evaluated based on the percentage of involvement and is given a value between 0 and 6. Each body region value is then weighted by a corresponding multiplier; lower extremities are weighted more while head and neck are weighted the least.2,7

Each region gets a total region score: Severity Score x Area Score x Multiplier = Region Score

The final EASI score is the sum of all 4 region scores. The composite score, on a scale from 0 to 72 determines the severity of the signs of eczema and the extent to which the patient is affected.2,7

An improvement of at least 75% in lesion extent and severity (EASI-75) from baseline is a clinically meaningful change.1

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Reference:
References:
  1. DUPIXENT Prescribing Information. March 2019.
  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. March 2019.
  7. Wei W, Anderson P, Gadhari 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. March 2019.
  9. DUPIXENT Prescribing Information. March 2019.
  10. Hanifin JM, Thurston M, Omoto M, Cherill R, Tofte SJ, Graeber M; the EASI Evaluator Group. The eczema area and severity index (EASI): assessment of reliability in atopic dermatitis. Exp Dermatol. 2001;10(1):11-18.
  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, placebocontrolled, 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 January 4, 2019.
  15. DUPIXENT Prescribing Information. March 2019.
  16. Data on file, Regeneron Pharmaceuticals, Inc.
  17. Blauvelt A, de Bruin-Weller M, Gooderham M, et al. Long-term management of moderateto-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. March 2019.
  20. 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.
  21. 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.
  22. Data on file, Regeneron Pharmaceuticals, Inc.
  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. March 2019.
  25. Data on file, Regeneron Pharmaceuticals, Inc.
  26. DUPIXENT Prescribing Information. March 2019.
  27. Data on file, Regeneron Pharmaceuticals, Inc.
  28. DUPIXENT Prescribing Information. March 2019.
  29. Boguniewicz M, Alexis AF, Beck LA, et al. Expert perspectives on management of moderateto-severe atopic dermatitis: a multidisciplinary consensus addressing current and emerging therapies. J Allergy Clin Immunol Pract. 2017;5(6):1519-1531.
  30. DUPIXENT Prescribing Information. March 2019.
  31. Data on file. Regeneron Pharmaceuticals, Inc.
  32. DUPIXENT Prescribing Information. March 2019.
  33. 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.
  34. Data on file, Regeneron Pharmaceuticals, Inc.
  35. DUPIXENT Prescribing Information. March 2019.
  36. 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.
  37. DUPIXENT Prescribing Information. March 2019.
  38. DUPIXENT Prescribing Information. March 2019.
  39. Data on file, Regeneron Pharmaceuticals, Inc.