People with moderate to severe atopic dermatitis (a type of eczema) may not be able to control their symptoms with topical treatments that are applied to the skin. In these cases, oral or injectable medicines that work directly on the immune system may be needed. For people who still have symptoms even after using some of these other medicines, an oral medicine called Cibinqo may help to relieve symptoms.
How does Cibinqo work for atopic dermatitis?
Atopic dermatitis, a type of eczema, is a long-term (chronic) condition of the skin that is caused by an overactive immune system. The overactive immune system weakens the skin barrier, causing the skin to become inflamed (swollen), irritated, and dry. This causes itchiness and a rash that can appear on many parts of the body. The most common parts of the body are the face, hands, feet, wrists, and the backs of the knees. The rash can be very different for different people, and may be red, dry, cracked, swollen, or bumpy. In some people, it also oozes and crusts over.
People with atopic dermatitis sometimes have “flare-ups,” or times when their symptoms are most noticeable. These flare-ups can last days or even weeks. In some cases, atopic dermatitis may get worse when the skin dries out. This can be due to cold or dry air, or from taking multiple baths or showers without moisturizing the skin afterward.
Many “triggers” can also make atopic dermatitis worse or cause a flare-up. For people who have allergies, exposure to an allergen (such as certain pollens, molds, animals, or foods) can trigger a flare-up. An infection, such as a cold or the flu, can also be a trigger. Certain substances can act as a trigger when they touch the skin, such as:
- Fragrances or dyes found in skin care products
- Irritating chemicals
- Rough materials (such as wool)
For most people, the key to treating atopic dermatitis is to avoid triggers, moisturize the skin, and apply topical treatments as prescribed. But this does not always work for people with moderate to severe atopic dermatitis, who may need treatments that target the body’s overactive immune system.
The active ingredient in Cibinqo is a medicine called abrocitinib, which works by blocking an enzyme called Janus kinase 1 (JAK1). JAK1 plays a role in sending immune system signals within the body. By blocking this enzyme, Cibinqo can help reduce the swelling and irritation that happen in people with atopic dermatitis.
Can anyone with atopic dermatitis use Cibinqo?
Cibinqo is approved for use in people with moderate to severe atopic dermatitis who have not been able to manage their symptoms by using other oral or injectable medicines. It may also be an option for people who are not able to use other oral or injectable medicines due to certain health risks or side effects.
For some people, Cibinqo may not be a safe option. It is important to speak with your health care provider about any past or current medical conditions, especially specific conditions such as blood clots, cancer, heart or lung problems, and kidney or liver problems. It is important for your health care provider to know if you have recently traveled to certain parts of the U.S. or to other countries, or if you have been around someone who has had a serious infection such as tuberculosis (TB). You should also let them know if you have ever smoked.
How was it studied for treating atopic dermatitis?
Four clinical studies were done to see if Cibinqo was safe and effective for the treatment of atopic dermatitis. Everyone in these studies had moderate to severe atopic dermatitis that still caused difficult symptoms even though they were using topical prescription medicines. About two-fifths (41%) still had symptoms even after trying an oral or injectable medicine.
Three of the studies only included adults (18 years and older), with an average age of 32-37. One study only included adolescents ages of 12-17, with an average age of 15. About half (53%) of the people in these studies were male and half (47%) were female. Most (67%) of the people were White, about 24% were Asian, and about 6% were Black. The race of the other people was not reported.
All of these studies measured efficacy by having a doctor rate a person’s rash before and during the study. Two scales were used to rate the rash:
- The Investigator’s Global Assessment (IGA), which runs from 0 to 4. A score of 4 means that the rash is very severe; a score of 0-1 means that the rash is either completely or almost gone.
- The Eczema Area and Severity Index (EASI), which uses different information about the rash to track changes in its size and severity over time
In three of the studies, including the study in adolescents, two different doses of Cibinqo (100 milligrams [mg] daily and 200 mg daily) were compared with a placebo. In one of the studies in adults, these two doses of Cibinqo were compared with a placebo and an injected medicine called dupilumab (Dupixent). Dupilumab is approved for the treatment of moderate to severe atopic dermatitis and works by blocking certain proteins that send immune system signals in the body (interleukin-4 and 13). No one in these studies knew whether they were receiving Cibinqo, dupilumab, or a placebo.
What benefits were seen in clinical studies in adults?
In two of the studies in adults, no one was allowed to use topical prescription treatments. In the study that compared Cibinqo with a placebo or dupilumab, everyone was allowed to use topical prescription treatments, and most people did.
- Improvement in symptoms. After 3 months, the adults who used Cibinqo or dupilumab were more likely to have their symptoms improve by at least 75% than the adults who used a placebo. The number of people who had their symptoms improve by at least 75% was different, depending on whether they were using topical prescription treatments:
| Cibinqo 200 mg daily | Cibinqo 100 mg daily | Dupilumab | Placebo | |
| Adults (NOT using topical treatments) | 61%-63% | 40%-45% | N/A | 10%-12% |
| Adults (allowed to use topical treatments) | 70% | 59% | 58% | 27% |
- Clear or almost clear skin. After 3 months, the people who used Cibinqo or dupilumab were more likely to have clear or almost-clear skin (a score of 0 or 1 on the IGA) than the people who used a placebo. The number of people who had clear or almost-clear skin was different, depending on whether they were using topical prescription treatments:
| Cibinqo 200 mg daily | Cibinqo 100 mg daily | Dupilumab | Placebo | |
| Adults (NOT using topical treatments) | 38%-44% | 24%-29% | N/A | 8%-9% |
| Adults (allowed to use topical treatments) | 48% | 37% | 37% | 14% |
This means that Cibinqo and dupilumab worked similarly well for improving symptoms and clearing the skin, and both medicines worked better than a placebo. For some people, symptoms may improve even more if they also use topical prescription medicines while taking Cibinqo.
What benefits were seen in the clinical study in adolescents?
In the study of people 12-17 years of age, everyone used topical prescription treatments.
- Improvement in symptoms. After 3 months, the people who used Cibinqo along with topical treatments were more likely to have their symptoms improve by at least 75% than the people who used a placebo:
Cibinqo 200 mg daily | Cibinqo 100 mg daily | Placebo |
| 72% | 69% | 42% |
- Clear or almost clear skin. After 3 months, the people who used Cibinqo along with topical treatments were more likely to have clear or almost-clear skin (a score of 0 or 1 on the IGA) than the people who used a placebo:
Cibinqo 200 mg daily | Cibinqo 100 mg daily | Placebo |
| 46% | 42% | 25% |
This means that Cibinqo worked better than a placebo for improving symptoms and clearing the skin.
How do I use it?
Cibinqo is a tablet that is taken by mouth once every day, with or without food. The tablet should be swallowed whole with a glass of water and should not be cut, crushed, or chewed. When you first start taking this medicine, you will start at the lower dose of 100 mg daily. Your health care provider will monitor your blood to see if Cibinqo is causing specific side effects. If you are not having side effects from the medicine, they may have you increase your dose to 200 mg daily. If you do get side effects, you may need to decrease your dose, stop taking the medicine for a few days, or stop taking the medicine completely.
If you miss a dose of Cibinqo, take it as soon as you remember. If your next dose is due in the next 12 hours, do not take the missed dose. Instead, take your next dose at the regularly scheduled time. Taking double or extra doses of this medicine can increase your risk of side effects.
How quickly will Cibinqo work for atopic dermatitis?
If Cibinqo is working, you should have fewer symptoms within the first 2-4 weeks of taking the medicine. Your symptoms may continue to improve over the first 2-3 months. Over time, this should mean that the rash will take up less space on your body and will not be as severe.
Do not stop using Cibinqo or any other medicines for atopic dermatitis without talking to your health care provider first, even if your rash has gotten better. Your rash and symptoms may get worse again if you stop or change any of your medicines.
Let your health care provider know if your symptoms have not improved after 1-2 months of taking the medicine. They may increase your dose, if you are not already at the highest dose, or may discuss your other treatment options.
How can I prevent or manage side effects?
People who use Cibinqo are more likely to have infections, especially an infection of the airways. These include infections in the nose or throat, a sore throat, or common cold symptoms. The best way to prevent infection is to reduce your exposure to germs by washing your hands and avoiding people who are sick. You should also stay current on vaccinations, such as getting an annual flu vaccine. Before you start Cibinqo, speak with your health care provider about whether you are due for any vaccines.
Some types of microbes that cause infections (such as viruses and bacteria) can stay in the body even after you have recovered from an infection. When this happens, the microbes are “latent,” which means they are not active and do not cause infection. In some cases, Cibinqo may cause these microbes to reactivate and cause a new infection. Before starting treatment with Cibinqo, it is important to let your health care provider know if you have had any serious infections in the past, such as tuberculosis (TB), hepatitis B, or chickenpox. You and your health care provider can discuss a plan to use the medicine safely or to consider other treatment options.
In rare cases, people who take Cibinqo may get a blood clot in their legs or lungs. These clots are more likely to happen in people who stay in the same position for long stretches of time. To help reduce your risk of a blood clot, it is helpful to change your position often, especially when you are traveling, sitting, or standing for long periods. Get medical help right away if you notice swelling, pain, or tenderness in your leg, or if you have sudden pain in your chest or trouble breathing.
Cibinqo may also cause other side effects, such as changes in certain blood levels. Your health care provider will monitor your blood after you start using Cibinqo. Make sure that you keep all of your appointments for bloodwork.
Are there any interactions with other medicines?
Let your health care provider know if you are taking an antiplatelet medicine, such as aspirin/dipyridamole, cilostazol, clopidogrel (Plavix), or ticagrelor (Brilinta). These medicines are used to prevent blood clots. Taking Cibinqo along with one of these medicines may increase your risk of bleeding.
There are many medicines that can alter the blood levels of Cibinqo. Some of these medicines may increase the side effects from Cibinqo, and others may reduce the effects of Cibinqo. Cibinqo may also alter the blood levels of other medicines. In certain cases, these effects are so significant that these medicines should not be taken together. Make sure your pharmacist or other health care provider is aware of all the prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, or other supplements you take or have recently taken.
Are there any interactions with vaccines?
It is important to discuss any recent or upcoming vaccines (immunizations) with your health care provider. There are certain vaccines (“live” vaccines) that you should not receive either right before starting Cibinqo or once you have already started using it. Your health care provider will confirm whether any recent or upcoming vaccines are safe.
Is there a coupon card available?
There is a savings coupon available from the drugmaker that may allow you to pay $0 for your prescription. Whether you are eligible depends on whether you have prescription insurance, and what type of insurance you have. You can find out more at www.cibinqo.com/savings-and-support-sign-up.
