Although many people with plaque psoriasis can control their symptoms by using topical treatments that are applied to the skin, some people with moderate or severe plaque psoriasis do not get enough benefit from these treatments. In these cases, medicines that are taken by mouth or injected into the body may be needed. These medicines act directly on the body’s immune system to help reduce symptoms.
One of these medicines, Skyrizi, was approved for the treatment of moderate or severe plaque psoriasis in 2019. Clinical research shows that this injectable medicine may work better than some of the other injectable medicines that have been approved for this same purpose in the past.
How Does Skyrizi Work for Plaque Psoriasis?
Plaque psoriasis, the most common form of psoriasis, is a type of autoimmune condition where 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, these plaques are itchy and uncomfortable. Plaques most often appear on the scalp, elbows, knees, and lower back, although some people may develop 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 flu, can also trigger a flare-up. Some other common triggers include:
- Dry 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 is not always enough for people with very bad symptoms. People with more severe plaque psoriasis may need additional treatments that target the body’s overactive immune system.
The active ingredient in Skyrizi is a medicine called risankizumab. This medicine, which is injected into the body, blocks a substance called interleukin-23 (IL-23) from working. People with plaque psoriasis have too much IL-23, which increases swelling. By blocking IL-23, Skyrizi can reduce the symptoms of plaque psoriasis.
Can Anyone With Plaque Psoriasis Use Skyrizi?
Most people with plaque psoriasis will be able to manage their symptoms with topical prescription medicines. However, 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, Skyrizi may be an option to discuss with your health care provider.
How Was It Studied?
Four studies were done to see if Skyrizi was safe and effective for the treatment of plaque psoriasis. All of the people in these studies had moderate to severe plaque psoriasis and were at least 18 years old. The average age was about 48, and most of the people (70%) were male. Most people (80%) were White, 16% were Asian, and 2.5% were Black. The race of the other people in the studies was not provided.
Many of the people in these studies had already tried non-topical treatments for their plaque psoriasis. More than two-thirds (38%) had tried light therapy, about half (48%) had tried oral medicines, and about two-fifths (42%) had tried an injectable medicine.
Here is some other important information about these studies:
- One study compared Skyrizi with a placebo. No one in the study knew whether they were receiving the medicine or the placebo.
- One study compared Skyrizi with another medicine called adalimumab (Humira). Adalimumab, which is injected into the body, is approved for the treatment of plaque psoriasis and works by blocking a substance called tumor necrosis factor (TNF). No one in the study knew which medicine they were receiving.
- Two studies compared Skyrizi with a placebo or another medicine called ustekinumab (Stelara). Ustekinumab, which is injected into the body, is approved for the treatment of plaque psoriasis and works by blocking multiple substances in the body. No one in these studies knew if they were receiving Skyrizi, ustekinumab, or a placebo.
All of these studies measured effectiveness in two ways:
- The number of people whose symptoms improved by at least 90% 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 4 months in the study, the people who used Skyrizi were more likely to have their symptoms improve by at least 90% from where they were before the study started. About three-quarters (72%-75%) of the people who used Skyrizi had their symptoms improve by this much. Here are the number of people who had their symptoms improve by 90% or more while receiving the other treatments used in these studies:
- Adalimumab: 47%
- Ustekinumab: 42%
- Placebo: 2%-5%
This means that Skyrizi worked better than any of these other options for improving symptoms.
In the study that compared Skyrizi with adalimumab, some of the people who were using adalimumab whose symptoms didn’t improve by 90% were switched to Skyrizi. After 4 months of using Skyrizi, about two-thirds (66%) of these people had their symptoms improve by at least 90%. This means that Skyrizi may be helpful for some people who still have symptoms after using adalimumab.
The number of people with clear or almost clear skin. After 4 months in the study, the people who used Skyrizi were more likely to have clear or almost-clear skin (a score of 0 or 1 on the sPGA). Most (84%-88%) of the people who used Skyrizi had this score. Here are the number of people who had clear or almost-clear skin while receiving the other treatments used in these studies:
- Adalimumab: 60%
- Ustekinumab: 63%
- Placebo: 7%-8%
This means that Skyrizi worked better than any of these other options for clearing the skin.
How Do I Use It?
Skyrizi is a liquid injected under the skin. When you start using this medicine, you will have an injection every 4 weeks for the first two doses. After that, you will have an injection every 12 weeks. Skyrizi can be injected into the thigh, stomach, or outer area of the upper arm.
Skyrizi comes in two forms. The most common form is a prefilled device that is ready to be injected under the skin, so you do not need to learn how to use a syringe and needle. The medicine also comes in a prefilled syringe with a needle. In either case, your health care provider will show you how to inject the medicine before you use it the first time. The medicine is stored in the refrigerator. To make the injection more pleasant, it is helpful to let it warm up to room temperature before using it.
It is important to inject the medicine properly so that you get the right dose. Your prescription should come with “Instructions for Use,” which explains how to prepare and give a dose. Ask your pharmacist or other health care provider if you are unsure how to use Skyrizi.
How Quickly Will Skyrizi Work for Plaque Psoriasis?
If Skyrizi is working, your symptoms will start to improve over the first 2-3 months. Most people see the greatest improvements during the second and third months of using the medicine. Some people may continue to see some improvement during the fourth month as well.
Do not stop using this 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 2-3 months of using Skyrizi. Your health care provider may discuss other options for treating this condition.
How Can I Prevent or Manage Side Effects?
Skyrizi can cause a skin reaction at the injection site, which may involve redness, pain, itching, and swelling. To help reduce the risk of this happening, don’t inject the medicine into a psoriasis plaque or any skin that is already tender, damaged, bruised, or scarred.
People who use Skyrizi 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 Skyrizi, speak with your health care professional about whether you are due for any vaccines.
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 Skyrizi, you can also report side effects to the FDA at 800-FDA-1088.
Are There Any Interactions With Other Medicines?
There are no known interactions between Skyrizi and other medicines. But it is still 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.
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 Skyrizi 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 Skyrizi?
Skyrizi 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 manufacturer that may allow you to pay as little as $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.skyrizi.com/psoriasis-psoriatic-arthritis/cost-and-savings.
