When Topical Rx Therapies Are Not Enough,Fast Itch Relief that Lasts

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. An endpoint included the 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 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 10.1-4

Patients experienced a significant reduction in itch, with some as early as Week 2, with DUPIXENT monotherapy in Trial 1 (secondary endpoint)1-3,a,b

Trial 1: Monotherapy at 16 Weeks

  1. Subjects who received rescue treatment or with missing data were considered as non-responders.
  2. Full Analysis Set (FAS) includes all subjects randomized.
  • 36% of patients with DUPIXENT (n=225) achieved ≥4-point reduction in NRS score vs 10% with placebo at Week 16 in Trial 2 (n=221; P<0.001)1-3

Significantly more patients had a sustained reduction in itch throughout 1 year of therapy with DUPIXENT + TCS vs placebo + TCS Trial 3 (secondary endpoint)2,5,a,b,c

Trial 3: Concomitant Therapy With TCS

  1. Subjects who received rescue treatment or with missing data were considered as non-responders.
  2. Full Analysis Set (FAS) includes all subjects randomized.
  3. In Trial 3, as needed, subjects received topical calcineurin inhibitors for problem areas only, such as the face, neck, and intertriginous and genital areas.
  4. Week 52 data were limited to patients completing 52 weeks as of the cut-off date.

Pruritus NRS Assesses the Average Itch Intensity Over the Previous 24 Hours4

A patient-reported measure that uses a 0- to 10-point scale, with which patients are asked4

“On a scale of 0 to 10, how would you rate your itch overall (on average) during the previous 24 hours?”

None
The Worst
Imaginable

A reduction of at least 4 points in pruritus NRS from baseline is a clinically meaningful change.1

EASI, Eczema Area and Severity Index; NRS, numerical rating scale.

Getting Started Thinking about prescribing
DUPIXENT? Find the information you
need to get started.
Start Now
Connect With a Rep Have questions about DUPIXENT? Get
answers from a representative.
Request a Visit
DUPIXENT MyWay Get information about DUPIXENT
MyWay
, a program with personalized
nursing and coverage support.
Explore Resources
  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.