When Topical Rx Therapies Are Not Enough...
Patients aged 12 to 17 years with uncontrolled moderate-to-severe atopic dermatitis can now experience visible results

A total of 251 adolescent patients in Trial 6 (16-week trial) with moderate-to-severe atopic dermatitis not adequately controlled with topical prescription treatments were randomized to DUPIXENT or placebo. Adolescents ≥60 kg received DUPIXENT 300 mg Q2W following two 300 mg loading doses, while adolescents <60 kg received 200 mg Q2W following two 200 mg loading doses. Eligible patients had an IGA score ≥3 (overall atopic dermatitis lesion severity scale of 0 to 4), an EASI score ≥16 on a scale of 0 to 72, and body surface area involvement of ≥10%. At baseline, 46% had an IGA score of 3 (moderate atopic dermatitis), 54% had an IGA of 4 (severe atopic dermatitis), mean EASI score was 36, and weekly averaged Peak Pruritus NRS was 8 on a scale of 0 to 10.1 In adolescent patients, 92% had at least one comorbid allergic condition such as allergic rhinitis, asthma, or food allergy1. The safety and efficacy of DUPIXENT have not been established in the treatment of allergic rhinitis or food allergy.

The primary endpoint was the change from baseline in the proportion of subjects with an IGA 0 (clear) or 1 (almost clear) and ≥2-point improvement at Week 16 (24% of patients treated with DUPIXENT vs 2% with placebo in Trial 6, P<0.0001). Other endpoints included change from baseline in the proportion of subjects with EASI-75 at Week 16 (improvement of ≥75%; 42% of patients treated with DUPIXENT vs 8% with placebo in Trial 6, P<0.0001) and reduction in itch as defined by ≥4-point improvement in the Peak Pruritus NRS at Week 16 (37% of patients treated with DUPIXENT vs 5% with placebo in Trial 6, P<0.0001).1


Itch relief

Significant itch reduction (Peak Pruritus NRS) at Week 16 with DUPIXENT in Trial 6 (secondary endpoint)1,2,a,b

Significant skin clearance

At least 75% improvement in lesion extent and severity (EASI-75) at Week 16 with DUPIXENT in Trial 6 (secondary endpoint)1,2,a

Significant skin clearance was demonstrated in adolescents (primary endpoint)1,2,c

Efficacy Results of DUPIXENT
at Week 16 (FAS)

DUPIXENT
(n=82)
PLACEBO
(n=85)
Achieved clear or almost-clear skin (IGA 0 or 1) 24% 2%

aFAS includes all subjects randomized.

bSubjects who received rescue treatment or with missing data were considered nonresponders (59% and 21% in the placebo and DUPIXENT arms, respectively).

cResponder was defined as a subject with an IGA 0 or 1 (clear or almost clear) and a reduction of ≥2-points on a 0-4 scale at Week 16 (primary efficacy outcome).

Demonstrated safety

The safety profile of DUPIXENT at Week 52 was similar to the safety profile observed at Week 16 in Trial 6 (adolescent trial) and in all 3 adult trials. The long-term safety profile in adolescents was consistent with that seen in adults.1

  • No adolescent patients treated with DUPIXENT discontinued treatment through Week 162

  • There is no requirement for initial lab testing or ongoing lab monitoring according to the Prescribing Information1


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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.