Consistent Proof of 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. Other endpoints measured included the proportion of subjects with EASI-75 (improvement of ≥75% in Eczema Area and Severity Index [EASI] score from baseline) and the mean improvement in 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.1-4

DUPIXENT demonstrated a significant improvement in disease extent and
severity at Week 16 vs placebo1,2,a,b

See Study Design

  1. LS (least-squares) mean changes from baseline.
  2. Full Analysis Set (FAS) includes all subjects randomized.
  • 51% and 44% of patients treated with DUPIXENT achieved EASI-75 in SOLO 1 and SOLO 2, respectively, vs 15% and 12% with placebo at 16 weeks (P<0.001)2,4
  • 36% and 30% of patients treated with DUPIXENT achieved EASI-90 in SOLO 1 and SOLO 2, respectively, vs 8% and 7% with placebo at 16 weeks (P<0.001)2,4

DUPIXENT + TCS demonstrated a significant improvement in lesion area
and severity at Week 16 and long-term improvement at Week 52 vs
placebo + TCS1,a,b,c,d

For all patients, moderate-to-severe atopic dermatitis was treated with concomitant TCS. Results are presented at 16 and 52 weeks.

See Study Design

EASI, Eczema Area and Severity Index; TCS, topical corticosteroids.

  1. LSM (least-squares mean) changes from baseline.
  2. Full Analysis Set (FAS) includes all subjects randomized.
  3. Week 52 data were limited to patients completing 52 weeks as of the cut-off date.
  4. This trial was not designed to evaluate maintenance of effect.
  • 69% and 65% of patients treated with DUPIXENT + TCS achieved EASI-75 at 16 weeks and 52 weeks, respectively, vs 23% and 22% with placebo + TCS (P<0.0001)1,4
  • 40% of patients treated with DUPIXENT + TCS achieved EASI-90 in the CHRONOS study vs 11% with placebo at 16 weeks (P<0.0001)4,5

See how EASI is scored using the clinical signs of atopic dermatitis

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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.