Many people with plaque psoriasis can control their symptoms by using topical treatments that are applied to the skin. But some people with moderate or severe plaque psoriasis have symptoms that do not respond to these treatments. In recent years, new medicines have been approved that work directly on the body’s immune system to help reduce symptoms.
Some medicines that work directly on the immune system are called Janus kinase (JAK) inhibitors. Sotyktu, which is taken by mouth, is the only JAK inhibitor that is approved for use in plaque psoriasis. This medicine may be an option for some people with more serious forms of this condition.
How Does Sotyktu Work for Plaque Psoriasis?
Plaque psoriasis, the most common form of psoriasis, is an autoimmune condition, which means that the body’s immune cells attack its own healthy cells. In people with plaque psoriasis, the immune system attacks healthy skin cells, which causes swelling (inflammation). This can lead to the formation of too many skin cells, causing discolored patches on the skin. These patches, which are known as “plaques,” are sections of thick, raised skin that may be covered with a thin silvery-white scale.
For many people, psoriasis plaques are itchy and uncomfortable. But it is important not to scratch the itchy areas, since this can cause the plaques to get bigger and thicker. Plaques most often appear on the scalp, elbows, knees, and lower back, although some people may get plaques on other parts of the body as well.
People with plaque psoriasis have “flare-ups,” or times when their symptoms are most noticeable. These flare-ups can last weeks or even months. Many different “triggers” can make psoriasis worse or cause a flare-up, including certain medicines. An infection, such as a cold or the flu, can also trigger a flare-up. Some other common triggers include:
- Dry and/or cold weather
- Stress
- Skin injuries, such as cuts or severe sunburns
- Smoking
- Drinking large amounts of alcohol
For most people, the key to treating plaque psoriasis is to avoid triggers, moisturize the skin, and apply topical treatments as prescribed. But this does not always work for people with very bad symptoms. People with more severe plaque psoriasis may need treatments that target the body’s overactive immune system.
The active ingredient in Sotyktu is a medicine called deucravacitinib, which blocks an enzyme in the body called tyrosine kinase 2 (TYK2) from working. TYK2 plays an important role in the process that ultimately leads to swelling. By blocking TYK2, Sotyktu can reduce the swelling in the skin in people with plaque psoriasis, reducing symptoms.
How Do I Use It?
Sotyktu is a tablet that is taken by mouth, one time each day. It can be taken with or without food, but it must be taken whole. The tablet should not be cut, crushed, or chewed.
Can Anyone With Plaque Psoriasis Use Sotyktu?
Most people with plaque psoriasis will be able to manage their symptoms with topical prescription medicines. But some people with moderate or severe plaque psoriasis may need to consider other options, such as oral or injected medicines, or a type of treatment called light therapy. If you are not able to manage your symptoms with topical treatments, Sotyktu may be an option to discuss with your health care provider.
How Was It Studied?
Two studies were done to see if Sotyktu is safe and effective for the treatment of plaque psoriasis. Everyone in these studies had moderate or severe plaque psoriasis and was at least 18 years old, with an average age of about 47. The people in the studies had already had plaque psoriasis for 18 years, on average, before the study started. Most (66%-68%) of the people in the studies were male. Most (87%) were White, about 10% were Asian, and about 2% were Black. The races of the other people were not provided.
In both of these studies, Sotyktu was compared with a placebo and another medicine, called apremilast (Otezla). Apremilast, which is taken by mouth and approved for use in plaque psoriasis, is a different type of medicine called a phosphodiesterase inhibitor. No one in the studies knew whether they were receiving Sotyktu, apremilast, or a placebo.
These studies measured efficacy in two ways:
- The number of people who had their symptoms improve by 75% or more during the study
- The number of people whose symptoms improved on a scale called the Static Physician’s Global Assessment (sPGA). A health care provider rates a person’s plaque psoriasis symptoms on this scale from 0 to 5. A score of 0 or 1 means that the skin is completely or almost completely clear of plaques. A score of 5 means that symptoms are severe.
What Benefits Were Seen in These Studies?
Improvement in symptoms. After four months in the study, the people who took Sotyktu were more likely to have their symptoms improve by at least 75% from where they were before the study started. About half (53%-58%) of the people who took Sotyktu had their symptoms improve by this much, compared with about one-third (35%-40%) of people who took apremilast and about 9%-12% of the people who took a placebo. This means that Sotyktu worked better than either apremilast or a placebo for improving symptoms.
The number of people with clear or almost clear skin. After four months in the study, the people who took Sotyktu were more likely to have clear or almost-clear skin (a score of 0 or 1 on the sPGA). About half (50%-54%) of the people who took Sotyktu had this score, compared with about one-third (32%-34%) of people who took apremilast and 7%-9% of people who took a placebo. This means that this medicine worked better than either apremilast or a placebo for clearing the skin. Almost all of the people taking Sotyktu who had a score of 0 or 1 after four months continued to have this score after a full year.
How Quickly Will Sotyktu Work for Plaque Psoriasis?
If Sotyktu is working, your symptoms will start to improve over the first few months, with most people seeing the greatest improvements during the second and third months of taking the medicine. Some people may continue to see some improvement during the fourth and fifth months as well.
Do not stop using Sotyktu or any other medicines for plaque psoriasis without talking to your health care provider first, even if your symptoms have gotten better. Your symptoms may get worse again if you stop or change any of your medicines.
Tell your health care provider if your symptoms do not seem to be improving after about three or four months of using Sotyktu. Your health care provider may discuss other options for treating this condition.
How Can I Prevent or Manage Side Effects?
People who use Sotyktu 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 Sotyktu, 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, Sotyktu may cause these microbes to reactivate and cause a new infection. Before starting treatment with Sotyktu, it is important to let your health care provider know if you have had any serious infections in the past, such as tuberculosis (TB) or hepatitis. You and your health care provider can discuss a plan to use Sotyktu safely or to consider other treatment options.
Sotyktu may cause muscle problems in some people, including muscle pain, weakness, and tenderness. In rare cases, the muscle may break down (rhabdomyolysis), which can lead to more serious health complications. Let your health care provider know if you have a history of any of these issues before you start using Sotyktu. Once you’ve started using the medicine, let your health care provider know right away if you have any unexplained symptoms of muscle pain, weakness, tenderness, or cramps.
These are not all of the possible side effects. 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 Sotyktu, you can also report side effects to the FDA at 800-FDA-1088 (800-332-1088).
Are There Any Interactions With Other Medicines?
It is important for your health care provider to be aware of all the prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, or other supplements you take or have recently taken. It is especially important to let your health care provider know if you are using any other medicines that may affect the function of your immune system.
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 Sotyktu or once you have already started using it. Your health care provider will confirm whether any recent or upcoming vaccines are safe.
Are There Any Special Steps Required to Get This Medicine?
Sotyktu is a type of medicine called a “specialty” medicine. This means that you can only get it from a specialty pharmacy and that it may require prior authorization from your insurance company.
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 https://www.sotyktu.com/savings-and-resources/sotyktu-360-support/co-pay-sign-up.
