Adult IGA Efficacy Results

DUPIXENT demonstrated long-lasting skin clearance

See the results from 3 pivotal, 16- and 52-week, randomized, placebo-controlled trials of adults with moderate-to-severe atopic dermatitis

Visible results in moderate-to-severe atopic dermatitis patients uncontrolled on topical Rx therapies

In DUPIXENT clinical trials including adults, 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

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 assessed 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

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to see results

Patient 2 achieved a 3-point improvement in IGA

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to see results

Patient 3 achieved a 4-point improvement in IGA

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to see results

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 Week 16 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)
Skin clearance seen with DUPIXENT in clinical trials was supported by real-world data5

aResponder 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).

bIn the primary analyses of the efficacy endpoints, subjects who received rescue treatment or with missing data were considered nonresponders.

cFull Analysis Set includes all subjects randomized.

dWeek 52 data were limited to patients completing 52 weeks as of the cutoff date.

Some adult patients not achieving the primary endpoint (IGA 0 or 1) still had changes in other validated measures6

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 166

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 include6:

  • 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

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.

Example representation of IGA scoring. Not an actual patient.

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, randomised, 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. Eichenfield LF, Gadkari A, Armstrong AW, et al. Real-world effectiveness of dupilumab based on Investigator Global Assessment (IGA) scores and Peak Pruritus Numerical Rating Scale (PNRS) in an electronic medical records dataset. Poster presented at: 77th Annual Meeting of the Society for Investigative Dermatology (SID); May 8-11, 2019; Chicago, IL.
  6. 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.

Important Safety
Information and Indication

CONTRAINDICATION: DUPIXENT is contraindicated in patients with known hypersensitivity to dupilumab or any of its excipients.

WARNINGS AND PRECAUTIONS

Hypersensitivity: Hypersensitivity reactions, including generalized urticaria, rash, erythema nodosum, anaphylaxis and serum sickness or serum sickness-like reactions, were reported in <1% of subjects who received DUPIXENT in clinical trials. If a clinically significant hypersensitivity reaction occurs, institute appropriate therapy and discontinue DUPIXENT.

Conjunctivitis and Keratitis: Conjunctivitis and keratitis occurred more frequently in atopic dermatitis subjects who received DUPIXENT. Conjunctivitis was the most frequently reported eye disorder. Most subjects with conjunctivitis or keratitis recovered or were recovering during the treatment period. Advise patients to report new onset or worsening eye symptoms to their healthcare provider.

Reduction of Corticosteroid Dosage: Do not discontinue systemic, topical or inhaled corticosteroids abruptly upon initiation with DUPIXENT. Reductions in corticosteroid dose, if appropriate, should be gradual and performed under the direct supervision of a physician. Reduction in corticosteroid dose may be associated with systemic withdrawal symptoms and/or unmask conditions previously suppressed by systemic corticosteroid therapy.

Atopic Dermatitis Patients with Comorbid Asthma: Advise patients not to adjust or stop their asthma treatments without consultation with their physicians.

Parasitic (Helminth) Infections: It is unknown if DUPIXENT will influence the immune response against helminth infections. Treat patients with pre-existing helminth infections before initiating therapy with DUPIXENT. If patients become infected while receiving treatment with DUPIXENT and do not respond to anti-helminth treatment, discontinue treatment with DUPIXENT until the infection resolves.

ADVERSE REACTIONS: The most common adverse reactions (incidence ≥1% at Week 16) in adult patients with atopic dermatitis are injection site reactions, conjunctivitis, blepharitis, oral herpes, keratitis, eye pruritus, other herpes simplex virus infection, and dry eye. The safety profile in children and adolescents through Week 16 was similar to that of adults with atopic dermatitis. In an open-label extension study, the long-term safety profile of DUPIXENT in adolescents and children observed through Week 52 was consistent with that seen in adults with atopic dermatitis.

DRUG INTERACTIONS: Avoid use of live vaccines in patients treated with DUPIXENT.

USE IN SPECIFIC POPULATIONS

  • Pregnancy: There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to DUPIXENT during pregnancy. Healthcare providers and patients may call 1-877-311-8972 or go to https://mothertobaby.org/ongoing-study/dupixent/ to enroll in or obtain information about the registry. Available data from case reports and case series with DUPIXENT use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. Human IgG antibodies are known to cross the placental barrier; therefore, DUPIXENT may be transmitted from the mother to the developing fetus.
  • Lactation: There are no data on the presence of DUPIXENT in human milk, the effects on the breastfed infant, or the effects on milk production. Maternal IgG is known to be present in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for DUPIXENT and any potential adverse effects on the breastfed child from DUPIXENT or from the underlying maternal condition.

Please see accompanying full Prescribing Information.

Indication

DUPIXENT is indicated for the treatment of patients aged 6 years and older with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. DUPIXENT can be used with or without topical corticosteroids.