for patients aged 12 to 17 years
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A total of 917 adult patients in Trials 1 and 2 (16-week trials), 251 adolescent patients in Trial 6 (16-week trial), and 421 adult patients in Trial 3 (52-week trial) with moderate-to-severe atopic dermatitis not adequately controlled with topical prescription
treatments were randomized to DUPIXENT or placebo. For all patients in Trial 3, lesions were treated with concomitant TCS. All adults received 300 mg Q2W following a 600 mg loading dose. Adolescents ≥60 kg also received this
dose, while adolescents <60 kg received 200 mg Q2W following a 400 mg loading dose. Eligible patients had an IGA score ≥3 (overall atopic dermatitis lesion severity scale of 0 to 4), an EASI score ≥16 on a scale of
0 to 72, and body surface area involvement of ≥10%. At baseline, 52% of adults and 46% of adolescents had an IGA score of 3 (moderate atopic dermatitis), 48% of adults and 54% of adolescents had an IGA of 4 (severe atopic dermatitis),
mean EASI score was 33 for adults and 36 for adolescents, and weekly averaged Peak Pruritus NRS was 7 on a scale of 0 to 10 for adults and 8 for adolescents.1
The primary endpoint was the change from baseline in the proportion of subjects with an IGA 0 (clear) or 1 (almost clear) and a ≥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; 24% of adolescents treated with DUPIXENT vs 2% with placebo in Trial 6, P<0.0001; 39% of adults treated with DUPIXENT + TCS vs 12% with placebo + TCS in Trial 3, P<0.0001). 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; 42% of adolescents treated with DUPIXENT vs 8% with placebo in Trial 6, P<0.0001; 69% of adults treated with DUPIXENT + TCS vs 23% with placebo + TCS in Trial 3, P<0.0001) and reduction in itch as 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; 37% of adolescents treated with DUPIXENT vs 5% with placebo in Trial 6, P<0.0001; 59% of adults treated with DUPIXENT + TCS vs 20% with placebo + TCS in Trial 3, P<0.0001.1-4
Clear or almost-clear skin
Improvement in lesion extent and severity
Demonstrated safety profile
There is no requirement for initial lab testing or ongoing lab monitoring
according to the Prescribing Information1
Consider DUPIXENT for your patients 12 years and older with moderate-to-severe atopic dermatitis who are uncontrolled on topical prescription therapies.See Dosing and Administration
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 in these patients. 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 adolescents through Week 16 was similar to that of adults with atopic dermatitis. In an open-label extension study, the long-term safety profile observed in adolescents 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 12 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.