Child EASI Efficacy Results

Children aged 6-11 years
achieved significant skin
clearance with DUPIXENT

See more from the 16-week, randomized, placebo-controlled trial in children aged
6-11 years with severe atopic dermatitis1

Significant skin clearance

6 -11 YEARS
At least 75% improvement in lesion extent and severity (EASI-75) with DUPIXENT + TCS at Week 16 in Trial 8 (secondary endpoint)1-3,a,b

aFull Analysis Set includes all subjects randomized.

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

cAt Day 1, subjects (baseline weight <30 kg) received 600 mg of DUPIXENT.

dAt Day 1, subjects (baseline weight ≥30 kg) received 400 mg of DUPIXENT.

Measuring disease extent and severity

EASI combines the severity of the signs of eczema and the extent of skin involvement.4

The severity of each of 4 eczema signs is assessed on a scale of 0 to 35

The extent of lesions in each body region is evaluated based on the percentage of involvement and is given a value between 0 and 6. Each body region value is then weighted by a corresponding multiplier; lower extremities are weighted more while head and neck are weighted the least.4,5

Each region gets a total region score:

Severity Score x Area Score x Multiplier = Region Score

The final EASI score is the sum of all 4 region scores. The composite score, on a scale from 0 to 72, determines the severity of the signs of eczema and the extent to which the patient is affected.4,5,a

An improvement of at least 75% in lesion extent and severity (EASI-75) from baseline is a clinically meaningful change.1

aIn patients <8 years of age, the multiplier for the head and neck are 0.2, the trunk is 0.3, the upper extremities are 0.2, and the lower extremities are 0.3.
In patients ≥8 years of age, the multiplier for the head and neck are 0.1, the trunk is 0.3, the upper extremities are 0.2, and the lower extremities are 0.4.

References:

  1. DUPIXENT Prescribing Information.
  2. Data on file, Regeneron Pharmaceuticals, Inc.
  3. Paller AS, Siegfried EC, Thaçi D, et al. Efficacy and safety of dupilumab with concomitant topical corticosteroids in children 6 to 11 years old with severe atopic dermatitis: a randomized, double-blinded, placebo-controlled phase 3 trial. J Am Acad Dermatol. 2020;83(5):1282-1293. doi:10.1016/j.jaad.2020.06.054
  4. EASI User Guide. HOME–Harmonising Outcome Measures for Eczema. Accessed March 11, 2020. www.homeforeczema.org/documents/easi-user-guide-jan-2017-v3.pdf
  5. 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.

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.