Hives (urticaria) are raised, itchy bumps on your skin. If you get itchy hives that come and go mostly every day for over six weeks, you might have a skin condition known as chronic spontaneous urticaria (CSU). In most cases, there isn’t a clear cause.
Sometimes, taking an over-the-counter (OTC) antihistamine medicine can help. But if OTC medicines aren’t helping enough, your health care provider may suggest trying a new medicine called Dupixent (dupilumab).
In April 2025, the FDA approved Dupixent for the treatment of CSU in certain adults and children. It is usually given as a shot under your skin (subcutaneous injection) every other week.
Dupixent is also commonly used to treat other conditions, such as asthma and eczema. This article addresses frequently asked questions about Dupixent for chronic spontaneous urticaria.
Is Dupixent Right for My Chronic Hives?
Dupixent is FDA-approved to treat chronic spontaneous urticaria (CSU) in adults and children ages 12 and older who still get hives despite taking antihistamine medicines.
Note that the FDA has not approved Dupixent for treating other types of hives. If you have CSU, talk with a health care provider if you are interested in trying Dupixent. Together, you can decide if Dupixent may be a good treatment option for you.
How Does Dupixent Work for Chronic Spontaneous Urticaria?
Dupixent helps treat chronic spontaneous urticaria (CSU) by calming a type of inflammation that leads to itching, redness, and welts. In CSU, certain immune cells can become overactive and release substances (such as histamine and cytokines) that trigger symptoms.
Dupixent works by blocking two proteins in the immune system called interleukin-4 (IL-4) and interleukin-13 (IL-13). These proteins play a key role in the inflammatory response that contributes to CSU. Dupixent attaches to a receptor, known as IL-4R alpha, which helps stop the inflammatory signals from spreading. By interrupting these pathways, Dupixent is thought to help reduce the immune system’s overactivity, leading to fewer flare-ups and improved symptoms.
People taking Dupixent for CSU may also have a gradual decline in blood levels of immunoglobulin E (IgE). (IgE is a type of antibody your immune system makes when it overreacts to an allergen.) This suggests that Dupixent may have a calming effect on allergy-related inflammation.
How Do I Use Dupixent for Chronic Spontaneous Urticaria?
Dupixent comes as a liquid in a single-dose, prefilled pen or a single-dose prefilled syringe. With proper training, you or a caregiver may be able to inject Dupixent at home. It is given as an injection under the skin (subcutaneous). It can be given under the skin of your thigh, stomach (not within 2 inches of your belly button), or the outer area of your upper arm (with a caregiver’s help).
Your health care provider will show you how to give Dupixent injections. To review the details, you can refer to the Instructions for Use that comes with your prescription.
To treat chronic spontaneous urticaria (CSU), most people use Dupixent once every two weeks. You will likely receive your first dose at your health care provider’s office or clinic.
For adults, the first dose is usually 600 milligrams, which requires two injections (300 milligrams each). After that, the typical adult dosage of Dupixent for CSU is one injection (300 milligrams) given every two weeks.
For children 12 years and older, the recommended dosage depends on body weight.
- Children who weigh between 66 and 132 pounds (30 to < 60 kilograms) will likely start with two injections (200 kilograms each) as the first dose. After that, the typical dosage is one injection (200 kilograms) given every two weeks.
- Children who weigh 132 pounds or more (60 kilograms or more) usually receive the same dosage as adults. They will likely start with two injections (300 kilograms each). After that, the typical dosage is one injection (300 kilograms) given every two weeks.
How Was Dupixent Studied for Chronic Spontaneous Urticaria?
Two clinical trials called CUPID Study A and CUPID Study C were done to test Dupixent’s effectiveness for treating chronic spontaneous urticaria in adults and children 12 and older. These studies included people with CSU whose symptoms did not get better with antihistamine medicines (such as loratadine) and had not tried certain treatments that target immunoglobulin E (IgE).
The clinical trials included a total of 287 people. Across both studies, the average participant age was 44 years old. About 68% of participants were female. Most were White (45%-68%), some were Asian (26%-42%), and a small percentage were Black (1%-2%). About 17% of the people identified as Hispanic or Latino.
To join the trials, people were required to have the following CSU symptoms:
- Itching, rated as 8 or higher on a scale of 0 to 21, based on a symptom rating scale called Itch Severity Score over 7 days (ISS7).
- Hives, with a total score of 16 or higher on a scale of 0 to 42, based on a symptom assessment tool called Urticaria Activity Score over 7 days (UAS7).
Most participants had severe symptoms at the start of the studies:
- In CUPID Study A, people reported an average itch score of 16 (ISS7) and a hives score of 31.4 (UAS7) at baseline.
- In CUPID Study C, the average itch score was 15.1 and the hives score was 28.2 at baseline.
In both trials, people were randomly assigned to receive either Dupixent or a placebo (a treatment with no medicine). No one in the study knew if the injection they were getting was Dupixent or placebo. Injections were given every two weeks for 24 weeks.
The main goal of both studies was to see how much Dupixent reduced itching. A key secondary goal was to see how much hives improved overall.
What Are the Benefits of Dupixent for Chronic Spontaneous Urticaria Based on Studies?
The main goal of the studies was to see how much Dupixent improved itching after 24 weeks of treatment. Researchers tracked this by asking people to rate their itch symptoms at the same time each day for a week. These daily scores were added together to get a weekly itch severity score (ISS7), with higher scores meaning more severe itching.
Another key goal of the studies was to see how much hives improved (overall urticaria symptoms). This involved tracking both itch scores and the number of hives people had each week. Together, these made up the Urticaria Activity Score over 7 days (UAS7).
Some of the main results are described below.
Itch severity (ISS7) at Week 24:
- In CUPID Study A, the Dupixent group had a 10.44-point reduction in itch score, while the placebo group had only a 6.02-point reduction.
- In CUPID Study C, the Dupixent group had an 8.5-point reduction in itch score, while the placebo group had a 6.13-point reduction.
Overall urticaria symptoms (UAS7) at Week 24:
- In CUPID Study A, people using Dupixent had nearly a 21-point reduction in overall hives symptoms, compared to a 12-point reduction in the placebo group.
- In CUPID Study C, the Dupixent group had a 15.6-point reduction in overall hives symptoms, while the placebo group had about an 11-point reduction.
Together, these results show that Dupixent is more effective than a placebo to relieve symptoms of chronic spontaneous urticaria (CSU) in people 12 and older who did not get enough symptom relief with antihistamines. Your results may be different from what was seen in studies.
How Fast Does Dupixent Start to Work for Chronic Spontaneous Urticaria? How Long Until I See the Full Effects of the Medicine?
In studies, some people started to feel less itchy and had fewer hives within the first few weeks of Dupixent treatment. It may take up to 12 to 24 weeks to see the full benefits of the medicine, based on study results.
Keep in mind that individual results may differ from what was seen in studies. Talk with a health care provider if you have questions about what to expect or if you do not notice improvement.
What Do We Know About the Effect of Dupixent in People Who Have Tried Anti-IgE Treatment?
As explained above, the results of CUPID Study A and Study C found that Dupixent was an effective treatment for people with CSU whose symptoms did not get better with antihistamine medicines (such as loratadine) and had not tried certain treatments that target immunoglobulin E (IgE).
Another study called CUPID Study B was done to see how well Dupixent worked in people with CSU who continued to have symptoms despite trying standard treatments, including antihistamines and anti-IgE treatments, such as omalizumab (Xolair).
The results of Study B showed that Dupixent led to some improvements in overall symptoms. While some improvement in itch severity was also seen, the results did not reach statistical significance. This means the results could have been due to chance and were not strong enough to confirm a clear benefit.
If you have already tried antihistamines and anti-IgE treatments without enough relief, talk to your health care provider about whether Dupixent could be an option for managing your CSU symptoms.
Is There Any Cost Assistance Available?
A cost assistance program is available from Sanofi-Aventis, the manufacturer of Dupixent. It may reduce the amount you pay. Whether you qualify to enroll may depend on what type of insurance you have or if you are uninsured. Visit this website from the drugmaker for more information about Dupixent costs and copay savings.
You can also contact the drugmaker at 844-387-4936 to connect with a representative for financial support information and other resources.
