Dupilumab, an injectable biologic that inhibits IL-4 and IL-13, received FDA approval in 2017 for the treatment of moderate to severe AD in adults whose disease is not adequately controlled with local prescriptions or when treatments are contraindicated.1In 2019, the indication of dupilumab was expanded to include patients with AD aged 12 to 17 years,2and recently the therapy was approved for the treatment of AD in patients as young as 6 years old.3The advanced therapy, the first available on the market to treat AD, offers an effective option for pediatric patients with severe disease.
As an immune-mediated inflammatory disease, atopic dermatitis (AD) often requires an intensive approach to care. While diligent basic skin care practices and topical therapies can be effective for mild to moderate disease, worsening disease severity requires more advanced therapies to relieve signs and symptoms such as dry skin and itching.
Amy Paller, MD, MS, is president of the International Society of Pediatric Dermatology, past president of the International Eczema Council and the Pediatric Dermatology Research Alliance (PeDRA), and past president of the scientific advisory board of the National Eczema Association. In addition, she is the Walter J. Hamlin Professor and Chair of Dermatology, Professor of Pediatrics, and Principal Investigator of the National Institutes of Health-funded Skin Biology and Disease Resource-based Center at Northwestern University's Feinberg School of Medicine. She joinedThe dermatologistto share her insights and perspectives on dupilumab in pediatric AD.
What impact could dupilumab and other emerging advanced therapies for Alzheimer's have on the quality of life of caregivers?
There is no doubt that AD is a disease that affects not only the affected child, but the entire family. It changes family dynamics; it affects the siblings and their relationship with the child, their time with the parent, and how children are treated within the family.
It is a condition that not only increases anxiety and depression in parents, but is also a financial drain. AD can also be a huge time constraint due to the local care required, along with all the extra attention the child needs to help avoid triggers. AD has several comorbidities, which can also affect the family, even when the AD is better controlled. Reducing the burden of AD is a benefit not only for the child, but for the entire family.
Children are often afraid of needles. What advice can you give to help patients and their caregivers overcome this fear of receiving dupilumab?
We are fortunate that the need for injection is usually the only problem with dupilumab. I remind the child and the family that we don't need to do lab tests. Sure, we were checking lab tests monthly with the immunosuppressants - and having a lab sign every 4 weeks can be more inconvenient than getting a lab test every 4 weeks.-week injection of dupilumab, often requiring multiple sticks.
Of course, that conversation doesn't help with the fear. In practice, we can use local anesthetics to ease the discomfort of sticking the needle into the skin and reduce anxiety. I will sometimes do that for the first few injections. Once kids get past these first few doses, they seem to feel like the injection just becomes another thing to do in their care plan, and the anesthetic cream is often left out. It helps to ensure that the dupilumab is not too cold for the injection - take it out of the refrigerator for 5 to 10 minutes.
We will often administer the former-time injection at the office and distracting the child. If we give a loading dose (split into two injections), the parent or caregiver will do the second. This makes the parent feel more comfortable and shows the child that a trusted person is capable of doing this and then continuing it.
I will say there are some families where the child really needs dupilumab, but the child is still so wild and scared that it can't be administered at home. We do have a few families that come over once a month to get that shot at the office; these are the hardest for everyone and distraction techniques are the best we can do with limited relief.
Two recent abstracts presented at AAAAI 2021 highlighted the efficacy of dupilumab in children with AD and allergic rhinitis or asthma, respectively.4,5Can you describe the overall efficacy of dupilumab in relieving symptoms of other atopic conditions?
We know that dupilumab has already been approved and has proven to be highly effective and commercially available for adolescents with asthma. Studies are ongoing on the use of dupilumab as an adjunct to subcutaneous immunotherapy for adults with allergic rhinitis. Anecdotally, we've heard of patients taking dupilumab finding they need less medication to treat their other allergic conditions. Unfortunately, the studies for AD have not well captured the effects of asthma and studies for asthma have not well captured the effects on AD in those subpopulations.
It is also important to realize that the severity of these comorbidities is not necessarily the same as the severity of the AD. Many of our children with AD who have other atopic comorbidities do not necessarily have severe asthma or allergic rhinitis.
That said, it's important to recognize that about 90% of children - whether they had severe AD and were 6 to 12 years old, or had moderate to severe disease and were 12 or 12 years old older - had another form of atopy. So dupilumab could be a win-win beyond AD for those children suffering from more than one atopic disorder.
What we do know is that it works equally well for AD in children with and without these various other atopic conditions.
Is there anything else you would like to share with your colleagues?
We are at such an exciting time regarding the treatment of atopic dermatitis in children, based on our growing understanding of the basis for the disease, including the differences based on age. Dupilumab was the first targeted agent, but we now look forward to the availability of other injectables that will provide choices for families with children with atopic dermatitis.
The other major new approach is the Janus kinase (JAK) inhibitors, which appear to be as promising as dupilumab in terms of efficacy and provide an oral option that can be easily stopped and restarted. With pediatric patients, however, it's all about safety. Despite their many benefits, many dermatologists will use JAK inhibitors selectively until more experience is gained.
References
1. Sanofi and Regeneron announce FDA approval of Dupixent® (dupilumab), the first targeted biologic therapy for adults with moderate to severe atopic dermatitis. Press release. Sanofi Regeneron; March 28, 2017. Accessed May 27, 2021.https://www.globenewswire.com/news-release/2017/03/28/946002/0/en/Sanofi-and-Regeneron-Announce-FDA-Approval-of-Dupixent-dupilumab-the-First-Targeted- Biological-therapy-for-adults-with-moderate-to-severe-atopic-dermatitis.html
2. FDA clears Dupixent® (dupilumab) for moderate to severe atopic dermatitis in adolescents. Press release. Sanofi Regeneron; March 11, 2019. Accessed May 27, 2021.https://www.prnewswire.com/news-releases/fda-approves-dupixent-dupilumab-for-moderate-to-severe-atopic-dermatitis-in-adolescents-300810264.html
3. Sanofi: FDA approves Dupixent® (dupilumab) as first biologic for children 6 to 11 years old with moderate to severe atopic dermatitis. Press release. Sanofi Regeneron; May 26, 2020. Accessed May 27, 2021.https://www.globenewswire.com/news-release/2020/05/26/2038798/0/en/Sanofi-FDA-approves-Dupixent-dupilumab-as-first-biological-medicine-for-children-aged- 6-to-11-years-with-moderate-to-severe-atopic-dermatitis.html
4. Beck L, Wollenberg A, Paller A, et al. Dupilumab improves signs and symptoms of severe atopic dermatitis in children aged 6-11 years with and without comorbid allergic rhinitis. J Allergy Clin Immunol. 2021;147(2):AB144. doi:10.1016/j.jaci.2020.12.523
5. Boguniewicz M, Sher L, Paller A, et al. Dupilumab improves signs and symptoms of severe atopic dermatitis in children 6-11 years of age with and without comorbid asthma.J Allergy Clin Immunol. 2021;147(2):AB32. doi:10.1016/j.jaci.2020.12.151
FAQs
Can kids take dupilumab for atopic dermatitis? ›
DUPIXENT is a prescription medicine used to treat adults and children 6 months of age and older with moderate-to-severe eczema (atopic dermatitis or AD) that is not well controlled with prescription therapies used on the skin (topical), or who cannot use topical therapies.
Is dupilumab FDA approved for atopic dermatitis pediatric? ›June 7, 2022. The U.S. Food and Drug Administration (FDA) has approved Dupixent® (dupilumab) for children aged 6 months to 5 years with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.
Is dupilumab safe for children? ›Improvements in atopic dermatitis symptoms were seen in children taking dupilumab, with minimal adverse events.
What is the downside of DUPIXENT? ›The most common side effects of DUPIXENT include:
eye and eyelid Inflammation, including redness, swelling, and itching, sometimes with blurred vision. cold sores in your mouth or on your lips. high count of a certain white blood cell (eosinophilia)
What are the disadvantages of dupilumab? The study suggests that dupilumab has a disadvantage in terms of eye problems. These occurred in 30 out of 100 people who used dupilumab, compared to only about 15 out of 100 people who had individually optimized treatment.
What are the side effects of dupilumab in children? ›- Allergic reactions. DUPIXENT can cause allergic reactions that can sometimes be severe. ...
- Eye problems. ...
- Inflammation of your blood vessels. ...
- Joint aches and pain.
Long-term side effects
These include eye-related side effects, such as changes in vision and new or worsening eye conditions. Long lasting side effects may also include eosinophilic conditions such as vasculitis (swelling and inflammation of blood vessels).
DUPIXENT is indicated for the treatment of adult and pediatric patients aged 6 months and older with moderate-to-severe atopic dermatitis (AD) whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.
How long does it take for DUPIXENT to start working? ›Key Points. For eczema in adults and adolescents, Dupixent (generic name: dupilumab) can start to work as quickly as 2 to 4 weeks to relieve itching and in 16 weeks for a clear or almost clear skin improvement.
Is DUPIXENT worth the risk? ›“Dupixent doesn't totally clear the risk of future eczema outbreaks, but it succeeds in managing symptoms,” he said. “Most of my patients experience less itching, a reduction in the rash, better sleep and a better quality of life overall.” But Dupixent isn't a cure, and it's not perfect.
Do you have to use DUPIXENT forever? ›
How long do I have to take Dupixent? Because of the chronic (recurring) nature of atopic dermatitis, you must remain on Dupixent to continue the clinical benefits of the drug.
Is DUPIXENT a high risk medication? ›Studies haven't found any increased risk of cancer in people who receive Dupixent. There is an increased risk of cancer with certain immunosuppressant medications used to treat severe eczema or asthma.
Is Dupixent toxic to the liver? ›Does Dupixent cause liver damage? Many studies have reported that Dupixent does not cause any serious effects on the liver. No study has reported clinically apparent acute liver injury attributed to dupilumab therapy. Dupilumab is a human monoclonal antibody and is unlikely to damage the liver.
Is Dupixent bad for kidneys? ›Discussion. Dupilumab proved to be safe and effective in these three patients with severe AD and concomitant kidney disease, without any adverse events or worsening of renal function during treatment.
How long can you stay on Dupixent? ›Dupixent Safe, Effective Up to Four Years in Adults With Moderate-to-Severe Atopic Dermatitis.
Does Dupixent have a black box warning? ›Dupixent does not have a black box warning, but there is a general warning noting hypersensitivity, conjunctivitis, and comorbid asthma.
What happens when you stop using Dupixent? ›Some flare quickly after stopping, while others can be off the drug for months and continue to do well. We have no way to predict this, and since most patients on Dupixent have a long history of more severe eczema, we largely encourage people who are responding to Dupixent to stay on the medication.
Does Dupixent cause a weakened immune system? ›Dupixent isn't known to weaken your immune system in a way that makes it easier for you to get infections. Instead, the drug reduces inflammation signals in your immune system that can cause eczema, asthma, and chronic sinusitis. (These are conditions Dupixent is used to treat.)
What is the latest treatment for eczema in children? ›Dupixent (dupilumab) is the first biologic medication approved by the U.S. Food and Drug Administration (FDA) for children aged 6 years and up with moderate to severe atopic dermatitis for whom topical treatments have not worked or are not advised.
Can dupilumab cause hair loss? ›Although hair loss is not reported in the product information as a side effect of Dupixent, there have been rare reports of hair loss published since the drug was approved. It is possible that Dupixent can cause hair loss in a very small number of people (also called drug-induced alopecia).
What is the new treatment for eczema in children? ›
INDICATIONEUCRISA is a prescription ointment used on the skin (topical) to treat mild-to-moderate eczema (atopic dermatitis) in adults and children 3 months of age and older.
How long can you stay on Dupixent for eczema? ›Dupilumab is an ongoing treatment rather than a treatment that is used for a fixed amount of time. Patients are reviewed after 16 weeks to see how effectively the treatment is working for them. If a patient's eczema has not responded adequately to dupilumab after 16 weeks, the treatment may be stopped.
Can Dupixent cause lymphoma? ›Abstract. In recent years, studies have associated dupilumab with unmasking or progression of cutaneous T-cell lymphoma (CTCL).
Is weight gain a side effect of Dupixent? ›Although weight gain is not listed as a side effect of Dupixent (dupilumab) in the product information, a published case series comparing 12 people prescribed Dupixent to 8 people prescribed methotrexate reported significant weight gain in those people prescribed Dupixent (an average of 6.1kg over one year; the amount ...
What is the best treatment for atopic dermatitis in kids? ›Topical corticosteroids are the first-choice therapy for eczema, and in most children, this treatment maintains good control of the dermatitis, with benefits that greatly exceed the uncommon adverse effects. When used as directed the safety profile of new topical corticosteroids is good.
What children are approved for dupilumab? ›DUPIXENT is a prescription medicine used: to treat adults and children 6 months of age and older with moderate-to-severe eczema (atopic dermatitis or AD) that is not well controlled with prescription therapies used on the skin (topical), or who cannot use topical therapies.
What is the peak age for atopic dermatitis? ›Because the peak age of onset of atopic dermatitis is during infancy, many patients may experience prolonged symptoms from infancy to adulthood.
What medications should not be taken with Dupixent? ›...
Here are some corticosteroid drugs that may interact with Dupixent:
- dexamethasone (Hemady)
- prednisone (Rayos)
- methylprednisolone (Medrol)
| ADOLESCENTS 12-17+ years of age DUPIXENT monotherapy | |
|---|---|
| 24% (P<0.001) | 2% |
| Secondary endpoint EASI-75: ≥75% improvement in lesion extent and severity (% of patients) | |
| 42% (P<0.001) | 8% |
| Secondary endpoint ≥4-point improvement in: Peak Pruritus NRS (in adultsh and adolescents) (% of patients) | |
Dupixent's cost may also be higher because it's an injectable medication and may only be available through specialty pharmacies. And in some cases, you need to visit your doctor to receive a dose. To learn more about ways to save on the cost of Dupixent, see the “Can I get help paying for Dupixent?” section below.
Is there a cheaper alternative to DUPIXENT? ›
Dupixent (dupilumab) is used to treat certain patients with eczema, asthma, and nasal polyps. There is currently no generic alternative to Dupixent. It may be covered by your Medicare or insurance plan, but some pharmacy coupons or cash prices could help offset the cost.
Does DUPIXENT make eczema worse? ›DUPIXENT can help reduce the signs and symptoms of eczema. Patients' individual results with DUPIXENT may vary.
Why can't you get live vaccines while on Dupixent? ›The prescribing information for dupixent does not recommend live virus vaccines during treatment but provides no references as to why. There is a theoretical concern that inhibition of IL-4 and IL-13 may impair immune response, probably more likely humoral response but also may affect T cell responses.
Can Dupixent cause depression? ›It's unlikely that taking Dupixent will make you feel depressed. Depression was not a side effect in clinical trials of Dupixent.
Does Dupixent cause eye problems? ›Advice for healthcare professionals: dupilumab is commonly associated with cases of conjunctivitis and allergic conjunctivitis, eye pruritus, blepharitis, and dry eye and with infrequent cases of keratitis and ulcerative keratitis, especially in patients with atopic dermatitis.
What age does FDA recommend DUPIXENT? ›DUPIXENT is indicated for the treatment of adult and pediatric patients aged 6 months 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.
What are the positive effects of DUPIXENT? ›DUPIXENT helps prevent severe asthma attacks (exacerbations) and can improve your breathing. DUPIXENT may also help reduce the amount of oral corticosteroids you need while preventing severe asthma attacks and improving your breathing.
Can Dupixent give you parasites? ›RCTs on anti-IL-4/IL-13 therapy such as dupilumab have also shown no occurrences of parasites or anaphylaxis; however, another rare adverse event, hypereosinophilia, occurred between 0.14% and 4.1% of the cases.
Can Dupixent cause TB? ›No study has reported so far that Dupixent reactivates latent infections, such as tuberculosis or hepatitis B, increases the risk of invasive fungal infections or unusual opportunistic infections, nor increases the progression of cancer.
Does Dupixent have a lower age limit? ›DUPIXENT is a prescription medicine used to treat adults and children 6 months of age and older with moderate-to-severe eczema (atopic dermatitis or AD) that is not well controlled with prescription therapies used on the skin (topical), or who cannot use topical therapies.
Can you get vaccines while on Dupixent? ›
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.
How do you travel with Dupixent? ›Follow these tips to take DUPIXENT while traveling. Store the syringes in the original carton to protect them from light. Refrigerate them at 36 °F to 46 °F. Do not store above 77 °F (25 °C).
Can you take prednisone while on Dupixent? ›No interactions were found between Dupixent and prednisone.
What age is dupilumab approved for atopic dermatitis? ›Press Release: Dupixent ® (dupilumab) recommended for expanded EU approval by the CHMP to treat children as young as six months old with severe atopic dermatitis.
When was DUPIXENT approved for atopic dermatitis in children? ›In June 2022 the U.S. Food and Drug Administration (FDA) approved Dupixent to treat moderate-to-severe atopic dermatitis in children 6 months to 5 years old who haven't achieved enough symptom relief with prescription corticosteroid creams or ointments, according to a statement from the drug's developers, Sanofi and ...
Do you have to use Dupixent forever? ›How long do I have to take Dupixent? Because of the chronic (recurring) nature of atopic dermatitis, you must remain on Dupixent to continue the clinical benefits of the drug.
Is Dupixent safe to take long-term? ›Dupixent Safe, Effective Up to Four Years in Adults With Moderate-to-Severe Atopic Dermatitis. Safe and effective long-term treatment is important for stable disease control in atopic dermatitis.
How long can you take dupilumab for? ›For eczema in adults and adolescents, Dupixent (generic name: dupilumab) can start to work as quickly as 2 to 4 weeks to relieve itching and in 16 weeks for a clear or almost clear skin improvement.
How I cured my child's eczema? ›Moisturize your baby's skin twice a day or as often as necessary to achieve relief. Consider topical corticosteroids. Commonly used to treat eczema, these medications help reduce inflammation and symptoms, such as itching. Topical corticosteroids come in many forms, including ointments, creams, sprays and lotions.
Can kids grow out of atopic dermatitis? ›Atopic dermatitis has no cure. But it will usually get better or go away as your child gets older. There may be times when your child has few or no symptoms. And he or she may have times when symptoms get worse.
Will my child outgrow atopic dermatitis? ›
Do children outgrow eczema? For some children, eczema starts to go away by age 4. However, some children may continue to have dry, sensitive skin as they grow up. It is hard to predict which children will outgrow the condition and which ones will have eczema as adults.
What is the first line treatment for atopic dermatitis in children? ›Topical corticosteroids should be first-line treatments for patients with atopic dermatitis flare-ups. Sedating antihistamines are indicated for the treatment of atopic dermatitis when patients have sleep disturbances and concomitant allergic conditions.