Children IGA Efficacy Results | DUPIXENT® (dupilumab)

Visible Results

A total of 367 children (6-11 years of age) in Trial 8 (16 weeks) with severe atopic dermatitis inadequately controlled with topical prescription therapies were randomized to DUPIXENT + TCS or placebo + TCS. This study compared both weight-tiered and non-weight-tiered dosing regimens. From these results, the recommended dosing for children aged 6-11 years is as follows: Patients ≥30 kg but <60 kg received 200 mg Q2W after a 400 mg loading dose. Patients <30 kg but >15 kg received 300 mg Q4W after a 600 mg loading dose. 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).^1,2

Full Analysis Set includes all subjects randomized.
In the primary analyses of the efficacy endpoints, subjects who received rescue treatment or with missing data were considered nonresponders.
At Day 1, subjects (baseline weight <30 kg) received 600 mg of DUPIXENT.
At Day 1, subjects (baseline weight ≥30 kg) received 400 mg of DUPIXENT.

Visible Results in Children

Actual patients in a Phase 3 pediatric DUPIXENT trial (Trial 8). All patients were prescribed concomitant TCS based on the clinical trial program. Patients 1, 2, and 3 were considered clinical responders. Individual results may vary.

6-year-old (Patient 1) achieved a 3-point improvement in IGA

Before
TreatmentBASELINE: IGA 4
(severe) Click and drag
to see results After
TreatmentWEEK 16: IGA 1
(almost clear)

10-year-old (Patient 2) achieved a 3-point improvement in IGA

Before
TreatmentBASELINE: IGA 4
(severe) Click and drag
to see results After
TreatmentWEEK 16: IGA 1
(almost clear)

9-year-old (Patient 3) achieved a 3-point improvement in IGA

Before
TreatmentBASELINE: IGA 4
(severe) Click and drag
to see results After
TreatmentWEEK 16: IGA 1
(almost clear)

6-year-old (Patient 4) achieved a 1-point improvement in IGA

Before
TreatmentBASELINE: IGA 4
(severe) Click and drag
to see results After
TreatmentWEEK 16: IGA 3
(moderate)

A clinical responder was defined as a patient achieving IGA 0 or 1

Patient 4 would not have met the primary endpoint in the clinical trial based on their IGA score at Week 16

See Changes in Adults Not Achieving IGA 0 or 1
See Changes in Adolescents (12 to 17 Years) Not Achieving IGA 0 or 1

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: 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.

Child IGA Efficacy Results

Visible Results

Significantly Clearer Skin in Children

Visible Results in Children

6-year-old (Patient 1) achieved a 3-point improvement in IGA

10-year-old (Patient 2) achieved a 3-point improvement in IGA

9-year-old (Patient 3) achieved a 3-point improvement in IGA

6-year-old (Patient 4) achieved a 1-point improvement in IGA

References: