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 treatments were randomized to DUPIXENT 300 mg Q2W or placebo. In Trial 3, concomitant TCS was used. Endpoint measured included the proportion of subjects with EASI-75 (improvement of ≥75% in Eczema Area and Severity Index [EASI] score from baseline). EASI is a composite score (ranging from 0 to 72) based on the extent and severity of the atopic dermatitis lesions.1,2

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

Trial 3: Concomitant Therapy With TCS

A majority of patients achieved significant 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
  1. 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 Trial 3 (other endpoint).
  2. Subjects who received rescue treatment or with missing data were considered non-responders.
  3. FAS includes all subjects randomized.
  4. Week 52 data were limited to patients completing 52 weeks as of the cut-off date.

Measuring disease extent and severity, and patient-reported symptoms

EASI combines the severity of the signs of eczema and the extent of skin involvement2

The severity of each of 4 eczema signs is assessed on a scale of 0 to 3.6

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.5,6

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.5,6

An improvement of at least 75% in lesion extent and severity (EASI-75) from baseline is a clinically meaningful change1

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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.