Rapid and Sustained Itch Reduction

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. Another endpoint measured was reduction in itch from baseline to Week 16 (all trials) and 52 (Trial 3) as defined by ≥4‑point improvement in the peak pruritus numerical rating key scale (NRS). The NRS is a patient-reported measure that assesses maximum itch intensity in the previous 24 hours using a point scale of 0 to 10. These daily reports were averaged for each study week to produce a weekly NRS score.1-4

Significant itch reduction with DUPIXENT as early as Week 2
and at Week 16 vs placebo1-3,a,b

See Study Design

  1. In the primary analyses of the efficacy endpoints, subjects who received rescue treatment or with missing data were considered non-responders.
  2. FAS includes all subjects randomized.

Significantly more patients experienced rapid and sustained itch reduction with DUPIXENT + TCS through 52 weeks vs placebo + TCS1,2,a,b,c

For all patients, moderate-to-severe atopic dermatitis was treated with concomitant TCS. Results are presented at 16 and 52 weeks.1

See Study Design

NRS, numerical rating scale; TCS, topical corticosteroids.

  1. In the primary analyses of the efficacy endpoints, subjects who received rescue treatment or with missing data were considered non-responders.
  2. FAS includes all subjects randomized.
  3. This trial was not designed to evaluate maintenance of effect.
  4. Week 52 data were limited to patients completing 52 weeks as of the cut-off date.
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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.