What Is It, and Why Does It Matter?
Dupixent (dupilumab) is a prescription biologic medicine given as an under‑the‑skin (subcutaneous) shot that helps reduce inflammation caused by certain immune system conditions, such as eczema, asthma, and chronic hives. The FDA has approved it as the first biologic treatment in the U.S. for children ages 2-11 years with chronic spontaneous urticaria (CSU) who continue to have symptoms despite taking histamine‑1 (H1) antihistamines (H1AHs).
CSU is a long-term inflammatory skin condition where type 2 inflammation plays a pivotal role. It causes sudden, unpredictable, and severe hives that come with frequent itching. Usually, medicines that target H1 receptors on cells (H1AHs) are used to relieve symptoms. However, more than 14,000 children in the U.S. ages 2-11 years do not get enough relief from these medicines. This leaves them with limited treatment options while they continue to have symptoms that seriously affect their daily lives.
Dupixent is a lab-made human monoclonal immunoglobulin (Ig) G4 antibody – a type of medication that uses the body's immune system to fight disease. This targeted biologic works by blocking signals from interleukin‑4 (IL‑4) and interleukin‑13 (IL‑13) – two major contributors to type 2 inflammation that are closely linked to the symptoms of CSU. By targeting this pathway, Dupixent may help reduce hives and itching when standard treatments fall short.
The approval matters because children ages 2-11 years with uncontrolled CSU now have a new treatment option that targets the causes of immune-activated inflammation rather than only relieving symptoms.
First approved in 2017, Dupixent has since been approved for several other conditions driven by type 2 inflammation, including atopic dermatitis (eczema), certain types of asthma, chronic rhinosinusitis with nasal polyps, eosinophilic esophagitis, prurigo nodularis, bullous pemphigoid, and allergic fungal rhinosinusitis across populations of different ages. CSU is the fifth such condition for which Dupixent is approved for children younger than 12 years of age.
Why Was It Approved?
The FDA's approval of Dupixent relied mainly on data from clinical studies involving adults and adolescents (ages 12 years or older) with CSU, supported by data about how Dupixent is processed in the body (pharmacokinetics) in children ages 2-11 years to determine its dosing and safety.
In two studies involving children with CSU who continued to have symptoms despite the use of H1AHs and without any prior treatment with anti-IgE therapy, adding Dupixent to standard H1AH therapy significantly reduced itching and overall hive severity, compared with a placebo, at 24 weeks. Similar results were seen in harder‑to‑treat cases where patients had not responded to both H1AHs and anti‑IgE therapy or could not tolerate anti-IgE therapy. Across these studies, Dupixent's safety profile was generally similar to what is already known for other dermatologic uses of dupilumab.
Reactions such as pain, swelling, and redness where the needle went in were the most common side effects, and no new adverse reactions were identified in children ages 2-11 years with CSU.
What Do I Need to Know?
Dupixent is available as single‑dose syringes or pens that are prefilled for subcutaneous use. Dupixent should be used under the guidance of a health care provider. It may be given in a clinic or at home after you or a caregiver has been trained to give it. If used at home for children ages 2-11 years, a caregiver should give the shot.
Children ages 2-5 years with CSU should receive the dose every four weeks, based on their weight, without any initial loading dose. Children ages 6-17 years should receive weight‑based dosing every two or four weeks after a one‑time loading dose. Dupixent is for treating CSU that remains active despite the use of H1AHs and is not for other types of hives.
If you miss a Dupixent dose, take it within seven days and then continue your regular schedule; if more than seven days have passed, restart a new dosing schedule from the day you take the shot, according to whether your doses are scheduled every two weeks or every four weeks.
Tell your health care provider about all of the medicines that your child takes, including prescription medicines such as oral, topical, or inhaled steroids; medicines for asthma; any over-the-counter medicines; vitamins; supplements; and herbal remedies. Do not change or stop other medicines that your child takes, including steroids, unless your health care provider tells you to.
Let your health care provider know about all the vaccines your child has taken, and avoid giving live vaccines right before and during treatment. Consider completing all age-appropriate vaccinations before starting Dupixent. Tell your health care provider if your child is allergic to dupilumab or any of its ingredients and has any eye problems or a worm (helminth) infection, as these need to be treated before starting Dupixent. But if your child gets them during treatment, and they do not clear with care, your health care provider may pause Dupixent until the issue is resolved.
Contact your health care provider right away if your child has signs of a serious allergic reaction, such as swelling of the face, lips, mouth, tongue, or throat; hives; a hard time breathing; and dizziness or lightheadedness, or if you notice new or worsening eye symptoms such as eye pain or changes in vision. These could be signs of serious side effects.