People with atopic dermatitis often need to use many medicines every day to help with their itchiness and rashes. There are treatment options that can be applied directly to the skin (also known as topical medicines), such as lotions and creams. Some people may use pills or shots to help prevent the symptoms. The goal is to reduce inflammation, keep your skin hydrated, stop the itching, reduce the rashes, and block your overactive immune system.
Nemluvio is a medicine designed to help reduce itching, which can lead to reduced inflammation and skin healing.
How Does Nemluvio Work?
Atopic dermatitis, also called eczema, is a long-term (chronic) skin condition that is caused by an overactive immune system. This weakens the skin barrier, which can cause the skin to be irritated and inflamed. It mostly affects the face, hands, arms, feet, wrists, and legs. People with atopic dermatitis commonly have very itchy (pruritus), dry, or sensitive skin, and red rashes.
In people with atopic dermatitis, a specific protein (IL-13) is overactive, which tells your nerves to produce more signals for itching. These signals go to your brain, causing an intense urge to scratch. The scratching causes inflammation, which can lead to dry, flaky, red skin and patches. The more you scratch, the more IL-13 signals are produced, which leads to more itching and rashes. This is called the "itch-scratch cycle."
If you have atopic dermatitis, you may have a flare-up (or exacerbation), when your symptoms are worse and may be more noticeable. The flare-ups can last for days or weeks and may involve more itching and rashes, or lead to skin infections. Although atopic dermatitis flare-ups have many causes, some of these flare-ups are caused by some of the following triggers.
- Things that irritate the skin, like soaps, detergents, cleaning products, perfumes, fabrics, or metals (like nickel)
- Common allergens, like dust mites, pet dander, pollen, and mold
- The weather, or sudden changes in the weather
- Stress
- Hormonal changes, like menstrual cycles or pregnancy
- Excessive sweating
- Very hot water with showers or baths
- Certain foods, like dairy, eggs, nuts, soy, and wheat
- Infections
- Some medicines
For mild to moderate atopic dermatitis, over-the-counter (OTC) moisturizers and topical prescription medicines can be applied directly to the affected areas to keep the skin hydrated and to help reduce redness, inflammation, and itching. But this may not always work for people with moderate to severe atopic dermatitis.
Nemluvio is the first and only self-injectable medicine designed to block the IL-13 protein to reduce the itch-scratch cycle. The reduction in itching and scratching helps to heal your skin.
How Should I Use This Medicine?
Nemluvio is a medicine that is injected under the skin every month. When starting Nemluvio, you will receive two doses for the first time. After this, you will inject Nemluvio every month.
Your health care provider may tell you to continue to use topical corticosteroids or other medicine while using Nemluvio.
The shot may be given by a health care provider or can be self-injected. Your health care provider will review with you or your caregiver the proper way to mix and give your shot.
If your symptoms improve, your health care provider will let you know how to continue treatment and when to stop other treatments.
If you store Nemluvio in the refrigerator, let the pen come to room temperature by letting it sit out of the refrigerator for 30 to 45 minutes. Injecting the medicine when it is cold may cause pain where the needle goes in. If you store the pen at room temperature, use the pen within 90 days.
If you are self-injecting Nemluvio, rotate where you give yourself the shot in your belly area or front upper thighs. Avoid your waistline or 2 inches around your belly button. Do not inject into skin that is tender, inflamed, swollen, damaged, or has bruises, scars, or open wounds
How Was It Studied?
Two studies (ARCADIA 1 and ARCADIA 2) have been done to look at the safety and efficacy of Nemluvio for the treatment of atopic dermatitis when used along with topical (applied to the skin) medicines, compared with a placebo. Placebo-controlled studies help researchers see differences in benefit or harm of a medicine when compared with no treatment. People in the studies had moderate to severe atopic dermatitis for at least two years and had affected areas on at least 10% of their body.
- Both studies included people who were at least 12 years old, with more than 80% older than 18.The average age in both studies was 33-35 years.
- Most of the people were White (73%-88%), with other people identifying as Black or African American (6%-8%), Asian (7%-19%), Native American or Alaska Native (0%-1%), Native Hawaiian or Other Pacific Islander (0%-1%), Other (0%-1%), and Multiple (0%-2%).
- Both studies included both males (48%-55%) and females (48%-52%).
Treatment with Nemluvio 30 mg or a placebo also included topical corticosteroids with or without topical calcineurin inhibitors (TCS-TCI). Efficacy was measured by a health care provider rating a person’s rash and itching using different scales (see table).
| Scale | Score Range | Meaning |
| Investigators Global Assessment (IGA) | 0-4 | 0 = Clear – rashes are gone 4 = Severe rashes |
| Eczema Area and Severity Index (EASI) | 0-72 | 0 = Clear – rashes are gone 72 = Severe rashes |
| Peak Pruritus Numerical rating scale (PP-NRS) for itching | 0-10 | 0 = No itching 10 = Worst imaginable itch |
People in the study had to have an IGA score 3 or 4, which is considered moderate to severe atopic dermatitis; an EASI score of at least 16; and a PP-NRS score of at least 4. Most people included in the studies had moderate atopic dermatitis, with severe itching noted by an IGA of 3 (67%-74%), average EASI of 27, and PP- NRS of at least 7.
Treatment success was defined with either of the following measures at week 16.
- IGA score of 0 or 1, with a change of at least 2 points on the IGA scale
- EASI-75, where at least 75% response in EASI score from the initial measurement
Other success measures included percentage of people with a PP-NRS improvement of at least 4 points; PP-NRS score below 2, which means a person was likely itch-free; or a combination of the IGA, EASI, and/or PP-NRS improvements.
What Benefits Were Seen in the Studies?
Both studies saw greater improvements in response for people receiving Nemluvio compared with a placebo. People in the Nemluvio saw fewer rashes and less itching by week 16. See the table below for responses in each study.
| Clinical Response – ARCADIA 1 | ARCADIA 1 | Placebo |
| IGA Success = score of 0 or 1 | 36% | 25% |
| EASI-75 = at least 75% improvement | 44% | 29% |
| PP-NRS score reduction by at least 4 | 43% | 18% |
| PP-NRS score < 2 | 31% | 11% |
| Clinical Response – ARCADIA 2 | ARCADIA 2 | Placebo |
| IGA Success = score of 0 or 1 | 38% | 26% |
| EASI-75 = at least 75% improvement | 42% | 30% |
| PP-NRS score reduction by at least 4 | 41% | 18% |
| PP-NRS score < 2 | 28% | 11% |
Your results may differ from what was seen in clinical studies. You and your health care provider should determine if the benefits outweigh any potential risks.
When Will Your Medicine Start Working?
Itching and rashes may get less frequent and less frequent within a few days. Track your symptoms and talk with your health care provider if the symptoms do not improve or get worse.
Who Should Not Receive Nemluvio?
You should not take Nemluvio if you are allergic to Nemluvio or any other ingredients in the pen. Your pharmacist can tell you about the ingredients in the pen.
How to Prevent and Manage Side Effects
The most common side effects of Nemluvio include headaches, muscle or joint pain, and hives. Talk to your health care provider if these side effects worsen or are not tolerable.
These are not all of the possible side effects. Talk with your health care provider if you are having symptoms that bother you. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088. In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.
What Types of Interactions Can Happen?
Nemluvio may interact with the following medicines. When starting or stopping Nemluvio, your health care provider may monitor the effects or amount of medicine you have in your blood.
- Warfarin, which is a blood thinner
- Cyclosporine, which is a medicine used to suppress your immune system
Talk to your health care provider about any vaccines you have recently received or have scheduled. You should not get certain vaccines right before or while using Nemluvio.
Tell your pharmacist or other health care provider about all the prescription or OTC medicines, vitamins/minerals, herbal products, or other supplements you take or have recently taken. Contact your health care provider if you believe you are having side effects due to a potential interaction.
Getting Your Medicine: What to Expect
Nemluvio is considered a specialty medicine, which is a high-cost medication that is taken for rare, complex, or long-term (chronic) diseases. It requires a different process than picking up your prescription at a local pharmacy. This process helps you stay on track with your treatment. Your health care provider will work with you, your insurance company, and/or the drugmaker to start the process.
Here are some differences that you may expect.
Insurance approval. Your insurance may require approval for using this medicine, also called a prior authorization. The insurance company reviews the prescription from your health care provider to make sure it is covered and determines the process that needs to be followed.
Pharmacy access. You may be required to use a specific pharmacy to get your medicine. Your health care provider will work with you and your insurance company on which pharmacy to use and the information that will be provided.
Copay assistance. There are programs from the drugmaker that may help with certain financial restrictions. Whether you are eligible depends on whether you have prescription insurance and what type of insurance you have. If you do not have insurance, there may be assistance based on specific financial criteria. You can find out more at www.nemluvio.com/eczema/galderma-patient-services or by calling 855-NEMLUVIO (855-636-5884).
