When Topical Rx Therapies Are Not Enough, Long-Lasting Skin Clearance

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. The primary endpoint was the change from baseline to Week 16 in the proportion of subjects with an Investigator's Global Assessment (IGA) of 0 (clear) or 1 (almost clear) and ≥2-point improvement. The IGA, performed by a healthcare professional, is a visual evaluation of the overall assessment of atopic dermatitis lesions on a severity scale of 0 (clear) to 4 (severe).1,2

Clear or almost-clear skin achieved by more patients at Week 16 (primary endpoint) and sustained at 1 year (secondary endpoint) with DUPIXENT + TCS vs placebo + TCS in Trial 31-3,a,b,c,d

Trial 3: Concomitant Therapy With TCS

  • 39% of DUPIXENT + TCS patients achieved clear or almost-clear skin at 16 weeks vs 12% with placebo + TCS (P<0.001)1,3

Significant skin clearance was also achieved in monotherapy trials (primary endpoint)1

  • 38% and 36% of patients achieved clear or almost-clear skin with DUPIXENT vs 10% and 9% with placebo at Week 16, in Trials 1 and 2 respectively (P<0.001)1,4
  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. Full Analysis Set (FAS) includes all subjects randomized.
  4. Week 52 data were limited to patients completing 52 weeks as of the cut-off date.

Visible Results in Moderate-to-Severe Atopic Dermatitis Patients Uncontrolled on Topical Therapies

Actual patients treated with DUPIXENT. Not clinical trial patients. Note that Patients 1, 2, and 3 were on concomitant therapies, such as TCS, phototherapy, etc, at their prescribing physician's discretion. Because these were real-world patients, there may be other factors influencing their treatment results, and individual results may vary.

Patient 1 achieved a 1-point improvement in IGA

Patient 1

Baseline (IGA 3)

Week 16 (IGA 2)

Patient 2 achieved a 3-point improvement in IGA

Patient 2

Baseline (IGA 3)

Week 16 (IGA 0)


Patient 3 achieved a 4-point improvement in IGA

Patient 3

before legs

Baseline (IGA 4)

after desktop

Week 1 (IGA 0)

Measuring the Severity of the Signs of Atopic Dermatitis

IGA assesses the overall severity of the clinical signs of atopic dermatitis2

A 0- to 4-point scoring system of the overall severity of atopic dermatitis skin lesions2

4

Severe
Disease

Severe erythema and severe
papulation/infiltration

3

Moderate
Disease

Moderate erythema and moderate
papulation/infiltration

2

Mild
Disease

Mild erythema and mild
papulation/infiltration

1

Almost
Clear

Just perceptible erythema, and
just perceptible papulation/infiltration

0

Clear

No inflammatory signs of dermatitis

A clinical responder was defined as a patient achieving an IGA 0 or 1 and at least a 2-point improvement from baseline1

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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.