Now approved for patients
aged 6 to 11 years
Not an actual patient.
Real patient treated with DUPIXENT.
Individual results may vary.
Now approved for patients
aged 6 to 11 years
Connect with a DUPIXENT Field Representative to get answers to any product-related questions you might have.
Consider DUPIXENT, dosed once every 4 weeks or every 2 weeks (depending on weight in pediatric patients), for your patients aged 6 years and older with moderate-to-severe atopic dermatitis who are uncontrolled on topical prescription therapies.See Dosing and Administration
When Topical Rx Therapies Are Not Enough…
Itch Relief and Skin Clearance1,3-6
Long-term Safety Profile1
Clinical Trial Outcomes
Supported by Real-world Data1,7,8
A total of 917 adults in Trials 1 and 2, 251 adolescents in Trial 6, 367 children (6-11 years of age) in Trial 8 (16 weeks each), and 421 adults in Trial 3 (52 weeks) with moderate-to-severe atopic dermatitis inadequately controlled with topical prescription therapies were randomized to DUPIXENT or placebo. All patients in Trials 3 and 8 received concomitant TCS. All adults and adolescents ≥60 kg received 300 mg Q2W after a 600 mg loading dose. Adolescents <60 kg and children ≥30 kg but <60 kg received 200 mg Q2W after a 400 mg loading dose. Children 15 kg but <30 kg received 300 mg Q4W after a 600 mg loading dose1
In Trials 1, 2, 3, and 6, patients had moderate-to-severe disease, with an IGA score ≥3 (overall lesion severity scale of 0 to 4), an EASI score ≥16 on a scale of 0 to 72, and BSA involvement ≥10%. In Trial 8, patients had an IGA score of 4 (severe), an EASI score ≥21, and BSA involvement ≥15%. At baseline, 52% of adults and 46% of adolescents had an IGA score of 3 (moderate), 48% of adults and 54% of adolescents had an IGA of 4 (severe); mean EASI score was 33 for adults, 36 for adolescents, and 37.9 for children; weekly averaged Peak Pruritus NRS was 7 for adults, 8 for adolescents, and 7.8 for children, on a scale of 0 to 10.1
The primary endpoint in Trials 1, 2, 3, and 6 was change from baseline in the proportion of subjects with an IGA 0 (clear) or 1 (almost clear) and ≥2-point improvement at Week 16 (38% and 36% of adults treated with DUPIXENT vs 10% and 9% with placebo in Trials 1 and 2, respectively, P<0.001; 39% of adults treated with DUPIXENT + TCS vs 12% with placebo + TCS in Trial 3, P<0.0001; and 24% of adolescents treated with DUPIXENT vs 2% with placebo in Trial 6, P<0.001). In Trial 8, the primary endpoint was change from baseline in the proportion of subjects with an IGA 0 or 1 at Week 16 (39% of children ≥30 kg treated with DUPIXENT + TCS vs 10% with placebo + TCS, and 30% of children <30 kg treated with DUPIXENT + TCS vs 13% with placebo + TCS).1,3-6
Other endpoints included change from baseline in the proportion of subjects with EASI-75 at Week 16 (improvement of ≥75%; 51% and 44% of adults treated with DUPIXENT vs 15% and 12% with placebo in Trials 1 and 2, respectively, P<0.001; 69% of adults treated with DUPIXENT + TCS vs 23% with placebo + TCS in Trial 3, P<0.0001; 42% of adolescents treated with DUPIXENT vs 8% with placebo in Trial 6, P<0.001; 75% of children ≥30 kg treated with DUPIXENT + TCS vs 26% with placebo + TCS, and 75% of children <30 kg treated with DUPIXENT + TCS vs 28% with placebo + TCS in Trial 8); and itch reduction defined by ≥4-point improvement in the Peak Pruritus NRS at Week 16 (41% and 36% of adults treated with DUPIXENT vs 12% and 10% with placebo in Trials 1 and 2, respectively, P<0.001; 59% of adults treated with DUPIXENT + TCS vs 20% with placebo + TCS in Trial 3, P<0.0001; 37% of adolescents treated with DUPIXENT vs 5% with placebo in Trial 6, P<0.001; 61% of children ≥30 kg treated with DUPIXENT + TCS vs 13% with placebo + TCS; and 54% of children <30 kg treated with DUPIXENT + TCS vs 12% with placebo + TCS in Trial 8).1,3-6
BSA, body surface area; EASI, Eczema Area and Severity Index; IGA, Investigator’s Global Assessment; NRS, numerical rating scale; Q2W, once every 2 weeks, Q4W, once every 4 weeks; TCS, topical corticosteroids.
Important Safety Information
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
Please see accompanying full Prescribing Information
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.