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 prescription 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.1,2

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

Actual patients treated with DUPIXENT. Not clinical trial patients. Patients 2 and 3 were on concomitant therapies, such as TCS, phototherapy, etc, at their prescribing physician’s discretion. Scoring was designated by the treating physician. Because all 3 patients were real-world patients, there may be other factors influencing their treatment results, and individual results may vary.

Patient 1 achieved a 3-point improvement in IGA

Patient 1

BASELINE: IGA 3 (moderate)

WEEK 16: IGA 0 (clear)

Patient 2 achieved a 3-point improvement in IGA

Patient 2

BASELINE: IGA 3 (moderate)

WEEK 16: IGA 0 (clear)

Patient 3 achieved a 4-point improvement in IGA

Patient 3

BASELINE: IGA 4 (severe)

WEEK 16: IGA 0 (clear)

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

Significantly Clearer Skin

18+ years

Skin clearance at Week 16 (primary endpoint) and Week 52 (secondary endpoint) with DUPIXENT + TCS in Trial 31-3,a-c

Trial 3: Concomitant Therapy With TCS

  • 39% of DUPIXENT + TCS adult patients achieved clear or almost-clear skin at 16 weeks vs 12% with placebo + TCS (primary endpoint; P<0.0001)1-3

Significant skin clearance was also achieved in adult monotherapy trials1,4

  • 38% and 36% of DUPIXENT patients achieved clear or almost-clear skin (primary endpoint) vs 10% and 9% with placebo at Week 16 in Trials 1 and 2, respectively (P<0.001)
  1. Responder was defined as a subject with IGA 0 or 1 (clear or almost clear) with a reduction of ≥2 points from baseline 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 nonresponders.
  3. FAS includes all subjects randomized.
  4. Week 52 data were limited to patients completing 52 weeks as of the cutoff date.

Some Patients Not Achieving the Primary Endpoint (IGA 0 or 1) Still Had Changes in Other Validated Measures5

In a pooled post hoc analysis of Trials 1 and 2, changes were seen among adult patients not achieving the primary endpoint of IGA 0 or 1 (and ≥2-point improvement) at Week 165

Endpoint DUPIXENT Placebo
Mean percent change (LSM) in Peak Pruritus NRS from baseline 35% 9%
Percentage of patients achieving EASI-75 21% 5%
Mean percent change (LSM) in EASI from baseline 49% 11%

Limitations of the pooled post hoc analysis of Trials 1 and 2 include5:

  • The analysis was imbalanced as there were significantly more patients not achieving the primary endpoint in the placebo group than in the DUPIXENT groups
  • No adjustments were made for multiple comparisons, therefore no definite conclusions may be drawn
  • Two imputation methods were implemented:
    • Post-baseline last observation carried forward (LOCF), with consideration of last value prior to rescue medication. Results presented above are LOCF
    • Observed values, disregarding use of rescue medication
  • LSM, least squares mean.

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
atopic dermatitis

Example representation of IGA scoring. Not an actual patient.

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

IGA, Investigator’s Global Assessment.

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References:
  1. DUPIXENT Prescribing Information.
  2. Data on file, Regeneron Pharmaceuticals, Inc.
  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, randomized, double-blinded, placebo-controlled, phase 3 trial. Lancet. 2017;389(10086):2287-2303.
  4. 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.
  5. Silverberg JI, Simpson EL, Ardeleanu M, et al. Dupilumab provides important clinical benefits to patients with atopic dermatitis who do not achieve clear or almost clear skin according to the Investigator’s Global Assessment: a pooled analysis of data from 2 phase III trials. Br J Dermatol. 2019;181(1):80-87.