Prurigo nodularis (PN) is a long-lasting skin condition that causes very itchy, hard bumps, often all over the body. The itch can be so intense that people scratch until the skin breaks, leading to pain, burning, and even infections. This constant itch-scratch cycle can make it hard to sleep and affect your mental and emotional well-being.
The symptoms of PN can be hard to control. Health care providers may prescribe steroid creams, light therapy, or medicines that calm the immune system or nerves. But these treatments do not always work well and can have side effects. Research has led to new treatments that help reduce itching and shrink the bumps on the skin.
In 2022, Dupixent (dupilumab) became the first medicine specifically approved to treat PN in adults. It is given as a shot and works throughout the body to help reduce inflammation and itch. It works by blocking certain pathways in your immune system.
Dupixent is also commonly used to treat other conditions, such as asthma and eczema. This article covers frequently asked questions about Dupixent for prurigo nodularis.
Is Dupixent Right for Me?
Dupixent is FDA-approved to treat prurigo nodularis (PN) in adults. It is not approved for this use in children.
If you have PN and are interested in trying Dupixent, talk with your health care provider. They can review your medical history to see if this medicine is right for you.
How Does Dupixent Work for Prurigo Nodularis?
Dupixent works by blocking certain signals in the body that lead to inflammation and itching in conditions like prurigo nodularis (PN). It targets two key proteins, called IL-4 and IL-13, that play a major role in the immune pathways involved in causing the symptoms of PN. By calming this type of inflammation, Dupixent can help relieve the intense itchiness and reduce the number of bumps on the skin. While the exact way it works is not fully understood, studies show that Dupixent helps interrupt the cycle of itch and inflammation that can make PN so hard to treat.
How Do I Use Dupixent for Prurigo Nodularis?
Dupixent comes as a liquid solution in a single-dose, prefilled pen or a single-dose prefilled syringe. With proper training, you or a caregiver can 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, with a caregiver’s help, the outer area of your upper arm.
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 PN, most people use Dupixent once every two weeks. The first dose is usually 600 milligrams, which requires two injections (300 milligrams each). You will likely receive your first dose at your health care provider’s office or clinic. After that, the typical dosage for PN is one injection (300 milligrams) given every two weeks.
How Was Dupixent Studied for Prurigo Nodularis? (Study Population, Exclusion Criteria)
Two clinical trials called PRIME and PRIME2 were done to test Dupixent’s effectiveness for treating prurigo nodularis (PN) in adults. These studies included adults with PN who had moderate to severe symptoms, even after using prescription skin treatments (such as topical corticosteroids or calcineurin inhibitors). To enter the study, all participants had to have the following symptoms:
- Severe itch (rated as a 7 or higher on a scale of 0 to 10)
- At least 20 skin bumps, also called nodules (people with 20 to 100 nodules were rated as having moderate symptoms, while those with more than 100 were rated as having severe symptoms)
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. Everyone received injections every two weeks. Each study lasted 24 weeks.
The clinical trials included a total of 311 people. Across both studies, the average participant age was about 50 years old. About 65% of participants were female and the rest were male. Around 57% were White, 34% were Asian, and 6% were Black. Many participants (43%) also had other conditions often seen in people with allergic or inflammatory disorders, such as eczema (atopic dermatitis), asthma, hay fever (allergic rhinitis), or food allergies.
To see how well Dupixent worked, researchers looked at how many people had a noticeable improvement in itchiness and how many had clear or almost clear skin.
What Are the Main Benefits of Dupixent Based on Studies?
To measure the effect of Dupixent for PN, a main goal of the studies was to see how many people had at least a 4-point improvement on a symptom rating scale for itchiness. Throughout the study, people were asked to rate how bad their itchiness felt in the last 24 hours on a scale of 0 to 10. This symptom rating scale is called the Worst Itch Numeric Rating Scale (WI-NRS) and ranges from 0 (“no itch”) to 10 (“worst imaginable itch”). A 4-point drop is considered a meaningful improvement.
The other main goal of the studies was to see how many people had clearer skin based on the number of skin bumps (nodules), using a scale called the Investigator's Global Assessment for Prurigo Nodularis-Stage (IGA PN-S). On this scale, a score of 0 means clear skin and a score of 1 means almost clear (5 or fewer nodules).
Across both studies, the results showed that Dupixent was more effective than a placebo for making skin clear or almost clear in people with PN. The scores on the symptom ratings scales for itchiness also decreased in these studies. This shows that Dupixent worked better than a placebo to treat itchiness, according to what people reported throughout the studies.
Some of the main clinical trial results are shown in the tables below. Your results may be different from what was seen in studies.
Table 1: Percentage of people with a score of 0 (“clear”) or 1 (“almost clear”) at week 24
| Dupixent (dupilumab) | Placebo |
PRIME Study | 48% | 18% |
PRIME2 Study | 45% | 16% |
Table 2: Percentage of people with at least a 4-point reduction in itch (on a rating scale of 0 to 10) at week 24
| Dupixent (dupilumab) | Placebo |
PRIME Study | 60% | 18% |
PRIME2 Study | 58% | 20% |
Does Dupixent Help With Other Symptoms of PN, Based on Studies?
In addition to relieving itch and clearing skin, Dupixent also helped improve other symptoms that affect daily life. By week 24, people taking Dupixent reported greater improvements than those on placebo in several areas:
- Skin pain, including burning and stinging sensations
- Sleep, with fewer disruptions due to itching
- Mental health, including symptoms of anxiety and depression
- Quality of life, measured by how much symptoms interfered with everyday activities using a rating scale
These results suggest that, for some people, Dupixent may help reduce the physical discomfort and emotional stress caused by symptoms of prurigo nodularis.
How Fast Does Dupixent Start to Work? How Long Until I See the Full Effects of the Medicine?
In clinical trials, some people started to feel less itchy and had fewer skin bumps within the first few weeks of Dupixent treatment. It may take 12 to 24 weeks to see the full benefits of the medicine.
While the main goal of Dupixent’s clinical trials for PN was to look for improvement by week 24, many people reported feeling less itchy earlier:
- About 37% to 44% of people using Dupixent had a drop of 4 points or more on a 0 to 10 itch scale by week 12.
- In comparison, only 16% to 22% of people using a placebo had the same level of itch relief by week 12.
Your results may be different 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 Long-Term Safety of Dupixent for Prurigo Nodularis?
The safety of Dupixent for PN was studied in two clinical trials, PRIME and PRIME2. Each study lasted 24 weeks, and researchers kept checking in with participants for 12 more weeks afterward to look for any safety concerns. Overall, Dupixent was well tolerated and most people did not have bad side effects.
Dupixent has been FDA-approved since 2017 and has been used long-term to treat other conditions such as eczema and asthma. In some asthma studies, people have used Dupixent for up to three years with no new safety concerns.
Overall, in the studies for PN, most people were able to stay on treatment. Some people (about 3% to 5%) had side effects that were mild, including:
- Cold symptoms, such as sore throat or runny nose
- Red or itchy eyes
- Dizziness
- Muscle aches
- Diarrhea
Injection site reactions are possible and may include pain, swelling, or irritation where Dupixent is given. These reactions are usually mild and temporary, but your health care provider may recommend a cool compress to ease discomfort.
This is not a full list of Dupixent side effects. Serious side effects are possible. Talk with your health care provider if you are having symptoms that bother you. If you experience anything that you think may be caused by Dupixent, you can also report side effects to the FDA at 800-FDA-1088 (800-332-1088).
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.