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DUPIXENT is a biologic with a novel mechanism of action to treat uncontrolled moderate‑to‑severe atopic dermatitis in patients aged 6 years and older1
When topical Rx therapies are not enough, DUPIXENT may be appropriate
Patients aged 6+ years may be appropriate for DUPIXENT if they:
- Have tried a variety of topical prescription therapies for moderate-to-severe atopic dermatitis and are still uncontrolled1
- Suffer from inadequate control of pruritus1
- Have ≥10% of their body covered with lesions and/or may involve problem areas, such as the face, hands, and feet1,2
- Have moderate-to-severe erythema and moderate-to-severe papulation/infiltration (IGA 3 or 4)1,3
Learn more about identifying appropriate patients to refer.
For your appropriate patients trapped in “flare then treat” cycles,
consider referring to a DERMATOLOGIST or ALLERGIST
Partner with an eczema specialist to help your patients. Use the Healthgrades®
tool to easily find nearby eczema specialists with experience in treating
children (aged 6 to 11 years), adolescents (aged 12 to 17 years), and adults
(aged 18+ years) with uncontrolled moderate-to-severe atopic dermatitis.
Sanofi US and Regeneron do not endorse or recommend any particular physician, and search
results do not include a comprehensive list of doctors in your area.
Unlike topical and oral corticosteroids, DUPIXENT specifically targets a
source of underlying inflammation to proactively treat atopic dermatitis1,4
Atopic dermatitis is a chronic, systemic disease driven in part by persistent
underlying type 2 inflammation3,5
- Even when patients are not in a flare, they continue to
experience underlying inflammation2 - Systemic treatment may be needed to help manage
uncontrolled moderate-to-severe atopic dermatitis1,6
Atopic Dermatitis
DUPIXENT has proven itch relief and skin
clearance in patients 6+ years of age with
uncontrolled moderate-to-severe atopic dermatitis1
Itch reduction3,7
Skin clearance1,7
DUPIXENT has a demonstrated
long-term safety profile across
patients aged 6 years and older1
Demonstrated safety profile
through 52 weeks1
Most Common Adverse Reactions
The most common adverse reactions (incidence ≥1% at Week 16) in adult patients with atopic dermatitis were 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.1
Trial Designs and Results
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 dose.1
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).1,3,7-9
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).1,3,7-9
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.
efficacy and safety read more on pediatric
efficacy and safety
Other attributes of DUPIXENT
DUPIXENT is not an
immunosuppressant
or a steroid1
No requirement for initial
lab testing or ongoing lab monitoring
according to the
Prescription Information1
One dose every 2 or 4 weeks (based
on age and weight) after initial loading
dose of two subcutaneous injections1
Extensive real-world experience1,3
≈163,000 new
atopic dermatitis
patients have
filled at least
1 DUPIXENT
prescription9,a,b
4 years on
the marketc
aIQVIA National Source of Business (NSOB) data as of March 2021.
bNew adult and pediatric patients with uncontrolled moderate-to-severe atopic dermatitis.
cFDA approved since 2017 for adults, 2019 for adolescents (aged 12-17 years), and 2020 for children (aged 6-11 years)
with uncontrolled moderate-to-severe atopic dermatitis.
Hear patient stories from other medical professionals who treat
uncontrolled moderate-to-severe atopic dermatitis
Dr Amy Spizuoco, Dermatologist
My patient has been on DUPIXENT for
quite awhile now. She told me she feels
so much more comfortable in her skin.
Hear real stories from real DUPIXENT patients
Britton, avid hiker, moderate disease
With my primary doctor and my dermatologist, I made
the decision to pursue treatment with DUPIXENT.
Actual patient treated
with DUPIXENT. Individual
results may vary.
Questions about DUPIXENT?
Below are the answers to some of the most frequently asked questions about DUPIXENT.
DUPIXENT is a biologic therapy that inhibits IL-4 and IL-13 signaling, two sources of type 2 inflammation. It is not an immunosuppressant or a steroid.1
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. Patients may be appropriate for DUPIXENT is they1:
- Have tried a variety of topical Rx therapies and are still uncontrolled
- Suffer from inadequate control of pruritus
- Have ≥10% of their body covered with lesions and/or may involve problem areas such as the face, hands, and feet
- Have moderate-to-severe erythema and moderate-to-severe papulation/infiltration (Investigator's Global Assessment [IGA] score of 3=moderate or 4=severe)
99% of adult commercial patients are covered for DUPIXENT, with 82% of those lives having to fail only 1 or 2 prescription topical treatments. You'll have to check with your patients' specific insurers to confirm their specific coverage.3,a
aData as of June 2021.
For patients with a valid prescription for DUPIXENT, support is available through the DUPIXENT MyWay® patient support program. Patients who enroll can receive:
- Insightful tips and tools to help them along the way
- Supplemental injection training virtually or over the phone
- Financial assistance for eligible patients
- Assistance with insurance questions
- Assistance locating a specialty pharmacy that can dispense DUPIXENT
DUPIXENT is typically prescribed by a specialist, such as a dermatologist or allergist. If you have a patient aged 6 years or older with uncontrolled moderate-to-severe atopic dermatitis who you think might be appropriate for DUPIXENT, consider referring them to an eczema specialist.
For help finding a specialist, use the Healthgrades tool.
Sanofi US and Regeneron do not endorse or recommend any particular physician, and search results do not include a comprehensive list of doctors in your area.
DUPIXENT MyWay® provides eligible patients with support
We're committed to helping ensure patients have access to DUPIXENT and are provided with assistance in navigating the insurance process.
- 99% of adult commercial patients nationally are covered for DUPIXENT, with
82% of those lives having to fail only 1 or 2 perscription topical treatments3,a
aData as of June 2021.
References:
- DUPIXENT Prescribing Information.
- Boguniewicz M, Alexis AF, Beck LA, et al. Expert perspectives on management of moderate-to-severe atopic dermatitis: a multidisciplinary consensus addressing current and emerging therapies. J Allergy Clin Immunol Pract. 2017;5(6):1519-1531.
- Data on file, Regeneron Pharmaceuticals, Inc.
- Gandhi NA, Bennett BL, Graham NMH, Pirozzi G, Stahl N, Yancopoulos GD. Targeting key proximal drivers of type 2 inflammation in disease. Nat Rev Drug Discov. 2016;15(1):35-50.
- Leung DYM, Boguniewicz M, Howell MD, Nomura I, Hamid QA. New insights into atopic dermatitis. J Clin Invest. 2004;113(5):651-657.
- Boguniewicz M, Fonacier L, Guttman-Yassky E, Ong PY, Silverberg J, Farrar JR. Atopic dermatitis yardstick: practical recommendations for an evolving therapeutic landscape. Ann Allergy Asthma Immunol. 2018;120(1):10-22.e2.
- Simpson EL, Bieber T, Guttman-Yassky E, et al; SOLO 1 and SOLO 2 Investigators. Two phase 3 trials of dupilumab versus placebo in atopic dermatitis. N Engl J Med. 2016;375(24):2335-2348.
- Blauvelt A, de Bruin-Weller M, Gooderham M, et al. Long-term management of moderate-to-severe atopic dermatitis with dupilumab and concomitant topical corticosteroids (LIBERTY AD CHRONOS): a 1-year, randomised, double-blinded, placebo-controlled, phase 3 trial. Lancet. 2017;389(10086):2287-2303.
- Simpson EL, Paller AS, Siegfried EC, et al. Efficacy and safety of dupilumab in adolescents with uncontrolled moderate to severe atopic dermatitis: a phase 3 randomized clinical trial. JAMA Dermatol. 2020;156(1):44-56.
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.
DUPIXENT® and DUPIXENT MyWay® are registered trademarks of Sanofi Biotechnology.
DUP.20.06.0186 Last Update: August 2020
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