Partner in care
Partner in Relief
DUPIXENT is a biologic with a novel mechanism of action to treat uncontrolled moderate‑to‑severe atopic dermatitis in adult and pediatric 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
have 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 SOLO 1 and SOLO 2, 251 adolescents in AD‑1526, 367 children (6‑11 years of age) in AD‑1652 (16 weeks each), and 421 adults in CHRONOS (52 weeks) with moderate-to-severe atopic dermatitis inadequately controlled with topical prescription therapies were randomized to DUPIXENT or placebo. All patients in CHRONOS and AD‑1652 received concomitant TCS. All DUPIXENT-treated 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 SOLO 1, SOLO 2, CHRONOS, and AD‑1526, 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 AD-1652, 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 SOLO 1, SOLO 2, CHRONOS, and AD‑1526 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 SOLO 1 and SOLO 2, respectively, P<0.001; 39% of adults treated with DUPIXENT + TCS vs 12% with placebo + TCS in CHRONOS, P<0.0001; and 24% of adolescents treated with DUPIXENT vs 2% with placebo in AD‑1526, P<0.001). In AD‑1652, 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 SOLO 1 and SOLO 2, respectively, P<0.001; 69% of adults treated with DUPIXENT + TCS vs 23% with placebo + TCS in CHRONOS, P<0.0001; 42% of adolescents treated with DUPIXENT vs 8% with placebo in AD‑1526, 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 AD‑1652) 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 SOLO 1 and SOLO 2, respectively, P<0.001; 59% of adults treated with DUPIXENT + TCS vs 20% with placebo + TCS in CHRONOS, P<0.0001; 37% of adolescents treated with DUPIXENT vs 5% with placebo in AD‑1526, 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 AD‑1652).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
Prescribing 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
≈221,000 new atopic dermatitis patients have filled at least 1 DUPIXENT prescription9,a,b
5 years on the market since initial FDA approval in ADc
aIQVIA National Source of Business Sanofi adjusted by Indication as of December 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
See how Dr Jennifer Soung
partnered with her 8-year
old
patient's pediatrician to help calm
persistent
inflammation.
When is it time for another
approach to treatment?
See
how
these providers assess their
appropriate patients.
INDICATION
DUPIXENT is indicated for the treatment of adult and pediatric
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.
IMPORTANT SAFETY
INFORMATION
CONTRAINDICATION:
DUPIXENT is contraindicated in patients with known
hypersensitivity to dupilumab or any
of
its excipients.
My name is Dr. Jennifer Soung, and I'm a dermatologist in Orange County, California.
An 8-year-old boy who is Southeast Asian was referred to me by his pediatrician because of really stubborn disease. My patient had seen his pediatrician for several months before coming to see me.
In skin of color, it can be harder to distinguish, or make a diagnosis because it may not look so typical. The appearance of the lesions are different, as well, because the redness isn’t always so bright.
Mom described it as his skin was on fire. Even at times, she said it was like an active volcano. It was always brewing; he never had clear skin.
He wanted to hide his eczema. Kids at school started to notice and would ask what was going on. Really, that sense of lack of control over his skin, his itching. What stood out for me in this situation that made me consider DUPIXENT, is really how DUPIXENT works. In this situation, the parents knew that they needed something more.
When I think about my patients who’ve had moderate-to-severe, uncontrolled atopic dermatitis, I think about DUPIXENT. When I prescribe DUPIXENT to my patient, I always share with them the most common adverse events.
The most common adverse reactions with an incidence greater than or equal to 1% at Week 16 in clinical trials were injection site reactions, conjunctivitis, blepharitis, oral herpes, keratitis, eye pruritus, other herpes simplex virus infections, and dry eye. After starting DUPIXENT on his first visit back to the office, I didn’t even need to ask him how he was doing because he just smiled at me. I knew that we were on the right path to healing his skin because he had described a relief in his itch. That was a big accomplishment.
I’ve seen him improve over several weeks, and his skin healed really well. He was wearing short sleeves and shorts when he came to the office. He no longer felt like he had to cover all his skin.
I remember mom and dad telling me it was like a huge weight that had been lifted off of them because they saw that this medicine was actually helping relieve that itch and break that itch-scratch cycle. So the family, as well as the patient, have been thrilled. And even the little boy, my patient, says that the injection now is worth it.
INDICATION
DUPIXENT is indicated for the treatment adult and pediatric 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.
IMPORTANT SAFETY
INFORMATION
CONTRAINDICATION:
DUPIXENT is contraindicated in
patients with known hypersensitivity to dupilumab or any
of its excipients.
The most important thing I want my patients to know is that atopic dermatitis is a systemic condition.
While there can be other triggers from the outside, once the inflammation starts from the inside, it sometimes is so intense that we need a systemic medication.
Many of the patients we’ve had who have come to us have been frustrated with their lack of progress. We’ve turned to DUPIXENT.
DUPIXENT is not an immunosuppressant or a steroid. DUPIXENT has demonstrated long-lasting skin clearance in clinical trials, at 16 weeks and at 1 year.
DUPIXENT has demonstrated rapid and sustained itch reduction in clinical trials with approximately 18% of adults treated with DUPIXENT and topical corticosteroids achieving significant reduction in peak pruritus NRS versus 8% with placebo and topical corticosteroids, as early as Week 2. At one year, 51% of adults treated with DUPIXENT and topical corticosteroids achieved significant itch reduction versus 13% with placebo and topical corticosteroids.
When I prescribe DUPIXENT to my patient, I always share with them the most common adverse events. The most common adverse reactions incidence greater than or equal to 1% at Week 16 in clinical trials were injection site reactions, conjunctivitis, blepharitis, oral herpes, keratitis, eye pruritus, other herpes simplex virus infections, and dry eye.
When I think about all my patients with moderate-to-severe, uncontrolled atopic dermatitis, I think about DUPIXENT.
INDICATION
DUPIXENT is indicated for the treatment adult and pediatric 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.
IMPORTANT SAFETY
INFORMATION
CONTRAINDICATION:
DUPIXENT is contraindicated in
patients with known hypersensitivity to dupilumab or any
of its excipients.
When I introduce DUPIXENT as a treatment option, we had a discussion of why we use DUPIXENT, and then possible side effects. When I think about my patients who’ve had moderate-to-severe, uncontrolled atopic dermatitis, I know that this patient needs a systemic treatment for their skin condition.
So with any therapy, discussing safety and side effects is very important. The most common adverse reactions with an incidence greater than or equal to 1% at Week 16 in clinical trials were injection site reactions, conjunctivitis, blepharitis, oral herpes, keratitis, eye pruritus, other herpes simplex virus infections, and dry eye.
When you’re introducing DUPIXENT to a patient that you think would be a good candidate to start this therapy, they often want to talk about efficacy. When I think of a patient, I think about this young man, and he came back to see me about 4 weeks later. He became less itchy, more comfortable. And he wasn’t constantly thinking about his skin. His skin had healed in ways that he had never experienced.
When we saw the patient back, his description of itching and the urge to scratch was much more encouraging. He felt like he had more control of his disease, more control of his itching as he was the one giving himself the shots. He felt like he was actually more involved in his treatment. And that gave him a sense of encouragement in terms of how he was going to break the itch-scratch cycle himself.
In order to get my patient and her mother more comfortable with using a medication that’s an injection, I explained to them that injection therapy is not a new treatment to our armamentarium or to any of our patients.
DUPIXENT has really revolutionized the way we treat atopic dermatitis.
Hear real stories from real DUPIXENT patients
Annie
High school student athlete
Severe disease
Watch how Annie found a
treatment with a demonstrated
safety and efficacy profile.
Growing up, my skin was flaking, my skin was itching. My skin was red. I would just scratch constantly, and the itching was something that I could never satisfy.
Over time, my itching got less and less. After starting treatment, I started noticing some changes with my skin. I noticed that the redness and irritation was reduced, and I noticed that the overall texture of my skin was smoother.
Today, I feel like I can manage my atopic dermatitis symptoms, and that is a huge relief! Of course, this is just my experience, and everyone’s experience with DUPIXENT will be different.
INDICATION AND IMPORTANT SAFETY INFORMATION
INDICATION
DUPIXENT is indicated for the treatment of adult and pediatric 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.
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 anaphylaxis, serum sickness or serum sickness-like reactions, angioedema, generalized urticaria, rash, erythema nodosum, and erythema multiforme have been reported. 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 compared to those who received placebo. Conjunctivitis was the most frequently reported eye disorder. Most subjects with conjunctivitis or keratitis recovered or were recovering during the treatment period. Conjunctivitis and keratitis have been reported with DUPIXENT in postmarketing settings, predominantly in atopic dermatitis patients. Some patients reported visual disturbances (e.g. blurred vision) associated with conjunctivitis or keratitis. Advise patients to report new onset or worsening eye symptoms to their healthcare provider. Consider ophthalmological examination for patients who develop conjunctivitis that does not resolve following standard treatment or signs and symptoms suggestive of keratitis, as appropriate.
Risk Associated with Abrupt Reduction of Corticosteroid Dosage: Do not discontinue systemic, topical or inhaled corticosteroids abruptly upon initiation of DUPIXENT. Reductions in corticosteroid dose, if appropriate, should be gradual and performed under the direct supervision of a healthcare provider. 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 Co-morbid Asthma: Advise patients not to adjust or stop their asthma treatments without consultation with their physicians.
Arthralgia: Arthralgia has been reported with the use of DUPIXENT with some patients reporting gait disturbances or decreased mobility associated with joint symptoms; some cases resulted in hospitalization. Advise patients to report new onset or worsening joint symptoms. If symptoms persist or worsen, consider rheumatological evaluation and/or discontinuation of DUPIXENT.
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.
Vaccinations: Consider completing all age-appropriate vaccinations as recommended by current immunization guidelines prior to initiating DUPIXENT. Avoid use of live vaccines in patients treated with DUPIXENT.
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.
USE IN SPECIFIC POPULATIONS
- Pregnancy: A pregnancy exposure registry monitors pregnancy outcomes in women exposed to DUPIXENT during pregnancy. To enroll or obtain information 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
ANNIE:
It was hard to not have a solution that worked for me. There was always something that I needed to do, always like a medicine I needed to take or a topical that I had to put on my skin.
SUE:
As a mom, I felt helpless, and we really felt out of control, and we needed to find something different that would work for her. Annie’s eczema specialist knew about DUPIXENT and thought that Annie was appropriate for it.
ANNIE:
Since starting DUPIXENT, my skin is a lot more clear. It’s a lot calmer.
SUE:
We did notice a difference within the first few weeks, and it has continually improved.
ANNIE:
My life doesn’t revolve around my skin anymore.
SUE:
Now, when she goes out and plays volleyball or hangs out with her friends, she can just be a kid, and that is a huge relief as a parent.
INDICATION AND IMPORTANT SAFETY INFORMATION
INDICATION
DUPIXENT is indicated for the treatment of adult and pediatric 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.
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 anaphylaxis, serum sickness or serum sickness-like reactions, angioedema, generalized urticaria, rash, erythema nodosum, and erythema multiforme have been reported. 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 compared to those who received placebo. Conjunctivitis was the most frequently reported eye disorder. Most subjects with conjunctivitis or keratitis recovered or were recovering during the treatment period. Conjunctivitis and keratitis have been reported with DUPIXENT in postmarketing settings, predominantly in atopic dermatitis patients. Some patients reported visual disturbances (e.g. blurred vision) associated with conjunctivitis or keratitis. Advise patients to report new onset or worsening eye symptoms to their healthcare provider. Consider ophthalmological examination for patients who develop conjunctivitis that does not resolve following standard treatment or signs and symptoms suggestive of keratitis, as appropriate.
Risk Associated with Abrupt Reduction of Corticosteroid Dosage: Do not discontinue systemic, topical or inhaled corticosteroids abruptly upon initiation of DUPIXENT. Reductions in corticosteroid dose, if appropriate, should be gradual and performed under the direct supervision of a healthcare provider. 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 Co-morbid Asthma: Advise patients not to adjust or stop their asthma treatments without consultation with their physicians.
Arthralgia: Arthralgia has been reported with the use of DUPIXENT with some patients reporting gait disturbances or decreased mobility associated with joint symptoms; some cases resulted in hospitalization. Advise patients to report new onset or worsening joint symptoms. If symptoms persist or worsen, consider rheumatological evaluation and/or discontinuation of DUPIXENT.
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.
Vaccinations: Consider completing all age-appropriate vaccinations as recommended by current immunization guidelines prior to initiating DUPIXENT. Avoid use of live vaccines in patients treated with DUPIXENT.
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.
USE IN SPECIFIC POPULATIONS
- Pregnancy: A pregnancy exposure registry monitors pregnancy outcomes in women exposed to DUPIXENT during pregnancy. To enroll or obtain information 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
Dear DUPIXENT,
My teenage daughter, Ore, has been dealing with severe atopic dermatitis for a few years now. What started off as patches of dry skin here and there turned into constant itching. We tried many different treatments. They’d work for a short time, but then her symptoms would come back again. It was hard for her and our family to manage. We saw a few different doctors. Eventually we were referred to Ore’s current specialist. He was committed to helping Ore find relief and manage her symptoms. And that is how we started treatment with DUPIXENT.
We were a little skeptical at first. Then we noticed her skin clearing and improving over time. It was such a relief to find something that works for her. Today, Ore is able to manage her symptoms and we are all very relieved. Thank you, DUPIXENT, for what you’ve done for my daughter. Thank you for helping her manage her eczema.
Sincerely,
Yetunde
INDICATION AND IMPORTANT SAFETY INFORMATION
INDICATION
DUPIXENT is indicated for the treatment of adult and pediatric 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.
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 anaphylaxis, serum sickness or serum sickness-like reactions, angioedema, generalized urticaria, rash, erythema nodosum, and erythema multiforme have been reported. 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 compared to those who received placebo. Conjunctivitis was the most frequently reported eye disorder. Most subjects with conjunctivitis or keratitis recovered or were recovering during the treatment period. Conjunctivitis and keratitis have been reported with DUPIXENT in postmarketing settings, predominantly in atopic dermatitis patients. Some patients reported visual disturbances (e.g. blurred vision) associated with conjunctivitis or keratitis. Advise patients to report new onset or worsening eye symptoms to their healthcare provider. Consider ophthalmological examination for patients who develop conjunctivitis that does not resolve following standard treatment or signs and symptoms suggestive of keratitis, as appropriate.
Risk Associated with Abrupt Reduction of Corticosteroid Dosage: Do not discontinue systemic, topical or inhaled corticosteroids abruptly upon initiation of DUPIXENT. Reductions in corticosteroid dose, if appropriate, should be gradual and performed under the direct supervision of a healthcare provider. 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 Co-morbid Asthma: Advise patients not to adjust or stop their asthma treatments without consultation with their physicians.
Arthralgia: Arthralgia has been reported with the use of DUPIXENT with some patients reporting gait disturbances or decreased mobility associated with joint symptoms; some cases resulted in hospitalization. Advise patients to report new onset or worsening joint symptoms. If symptoms persist or worsen, consider rheumatological evaluation and/or discontinuation of DUPIXENT.
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.
Vaccinations: Consider completing all age-appropriate vaccinations as recommended by current immunization guidelines prior to initiating DUPIXENT. Avoid use of live vaccines in patients treated with DUPIXENT.
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.
USE IN SPECIFIC POPULATIONS
- Pregnancy: A pregnancy exposure registry monitors pregnancy outcomes in women exposed to DUPIXENT during pregnancy. To enroll or obtain information 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
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 adult and pediatric 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 commercial patients nationally are covered for DUPIXENT, with 82% of adult and adolescent patients having to fail only 1 or 2 prescription topical treatments, and 76% of children ages 6 to 11 years having to fail only 1 or 2 topical treatments.3,a
aMMIT Analysis, August 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 commercial patients nationally are covered for DUPIXENT, with 82% of adult and adolescent patients having to fail only 1 or 2 prescription topical treatments, and 76% of children ages 6 to 11 years having to fail only 1 or 2 topical treatments.3,a
aMMIT Analysis, August 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 anaphylaxis, serum sickness or serum sickness-like reactions, angioedema, generalized urticaria, rash, erythema nodosum, and erythema multiforme have been reported. 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 compared to those who received placebo. Conjunctivitis was the most frequently reported eye disorder. Most subjects with conjunctivitis or keratitis recovered or were recovering during the treatment period. Conjunctivitis and keratitis have been reported with DUPIXENT in postmarketing settings, predominantly in atopic dermatitis patients. Some patients reported visual disturbances (e.g. blurred vision) associated with conjunctivitis or keratitis. Advise patients to report new onset or worsening eye symptoms to their healthcare provider. Consider ophthalmological examination for patients who develop conjunctivitis that does not resolve following standard treatment or signs and symptoms suggestive of keratitis, as appropriate.
Risk Associated with Abrupt Reduction of Corticosteroid Dosage: Do not discontinue systemic, topical or inhaled corticosteroids abruptly upon initiation of DUPIXENT. Reductions in corticosteroid dose, if appropriate, should be gradual and performed under the direct supervision of a healthcare provider. 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 Co-morbid Asthma: Advise patients not to adjust or stop their asthma treatments without consultation with their physicians.
Arthralgia: Arthralgia has been reported with the use of DUPIXENT with some patients reporting gait disturbances or decreased mobility associated with joint symptoms; some cases resulted in hospitalization. Advise patients to report new onset or worsening joint symptoms. If symptoms persist or worsen, consider rheumatological evaluation and/or discontinuation of DUPIXENT.
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.
Vaccinations: Consider completing all age-appropriate vaccinations as recommended by current immunization guidelines prior to initiating DUPIXENT. Avoid use of live vaccines in patients treated with DUPIXENT.
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.
USE IN SPECIFIC POPULATIONS
- Pregnancy: A pregnancy exposure registry monitors pregnancy outcomes in women exposed to DUPIXENT during pregnancy. To enroll or obtain information call 1-877-311-8972 or go to https://mothertobaby.org/ongoing-study/dupixent/. 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 adult and pediatric 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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