CHILD STUDY DESIGN

Expanding the largest clinical development program in atopic dermatitis with a trial in children

Explore the 16-week, randomized,
placebo‑controlled trial in children aged
6 to 11 with uncontrolled severe
atopic dermatitis1

DUPIXENT + TCS was evaluated in 367 children (6-11 years of age) in Trial 8 whose severe atopic dermatitis was inadequately controlled on topical Rx therapies1,a

Disease severity was defined by an IGA score of ≥4 in the overall assessment of atopic dermatitis lesions on a severity scale of 0 to 4, an EASI score ≥21 on a scale of 0 to 72, and a minimum body surface area involvement of ≥15%.1

Primary endpoint in the study subjects with an IGA 0 (clear) or 1 (almost clear) at Week 161

Children (6-11 years of age)1,a
Number of
patients1,a

367

Pivotal
trialsb

1 double-blind
DUPIXENT
vs placebo;
all patients
received
concomitant TCS

Dosingc

For patients 15 kg to <30 kg, a loading dose of 600 mg (2 x 300 mg SC injections) followed by 300 mg (1 SC injection) Q4W or for patients ≥30 kg to <60 kg, a loading dose of 400 mg (2 x 200 mg SC injections) followed by 200 mg (1 SC injection) Q2Wd

Disease severity at baseline
Severe atopic dermatitis
(IGA 4)

100%

Disease extent at baseline
Mean EASI score
Mean body surface
area involvement
38
out of 72

58%

Itch severity at baselinee
Peak Pruritus NRS
7.8
out of 10

Clinical trials in children included 1 trial with concomitant TCS (Trial 8) and 1 open-label extension trial (Trial 7); both trials initiated with 2 DUPIXENT (200 mg or 300 mg) or placebo subcutaneous injections at Week 0 based on the child’s weight.1

aThese baseline characteristics are not meant for comparison.

bAt baseline, mean disease duration was ≈7 years. Mean age was 8.5 years.

cEmollient background regimen was required. The study design tested both weight-tiered and non–weight-tiered dosing. Based on results, the approved dosing was weight-tiered.

dStudied vs placebo.

eWeekly averaged Peak Pruritus NRS score (10 indicates the most severe).

The safety profile in children through Week 16 was similar to that of adults with atopic dermatitis1

Explore the safety profile of
DUPIXENT in children

Reference:

  1. DUPIXENT Prescribing Information.

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.