People with Crohn’s disease often take medicines to help manage their condition and improve their symptoms. Some of these medicines are taken by mouth and stay inside of the digestive tract. But people with moderate or severe Crohn’s disease may not get enough benefit from these medicines. They may need to take an oral or injected medicine that works directly on the body’s immune system to reduce symptoms and stop the damage to the intestines.
One of these medicines, called Skyrizi, may help to improve symptoms in people who do not get enough benefit from other medicines that work on the body’s immune system.
How Does Skyrizi Work for Crohn’s Disease?
Crohn’s disease is a type of inflammatory bowel disease (IBD), which causes irritation and swelling (inflammation) in the intestines. IBD is an autoimmune disorder, meaning that the swelling is caused by the body’s immune system attacking healthy cells in the intestines. Over time, the swelling can cause significant damage to the digestive tract, leading to serious long-term complications.
Swelling in the intestines can cause diarrhea and urgency, constipation, blood in the stools, and stomach pain and cramps. Many people with Crohn’s disease also have a reduced appetite, weight loss, and feel very tired and low in energy.
Some people with this condition will have periods of “remission,” when the swelling, pain, and other symptoms go away for some length of time. Many people will also have “flare-ups,” where symptoms become much worse. These flare-ups can last for weeks or months and may be due to stress or changes in treatment. If a person is having Crohn’s symptoms, their disease is considered “active.”
The key to treating Crohn’s disease is to reduce the swelling in the intestines. This can help to reduce symptoms and also prevent ongoing damage to the digestive tract. It is important to start treatment as soon as possible after receiving a diagnosis, so that the damage does not become severe. There are multiple methods for treating Crohn’s disease, including diet changes, medicines, and surgery.
Many of the medicines used to treat Crohn’s disease are taken by mouth and stay inside of the digestive tract. But there are many other medicines that can also be used to help treat symptoms. Some of these other medicines, which can be taken by mouth or injected into the body, work on 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 Crohn’s disease have too much IL-23, which can increase swelling and irritation in the digestive tract. By blocking IL-23, Skyrizi can reduce the symptoms and damage that happen with Crohn’s disease.
How Was It Studied?
Two studies were done to see if Skyrizi is safe and effective for the treatment of active Crohn’s disease. A third study was done to see if Skyrizi can help people who are already in remission to stay in remission. All of the people in these studies had moderate to severe Crohn’s disease and had been diagnosed about 10 years before the study started, on average.
In all three of these studies, everyone was at least 18 years old, with an average age of 39. About half (47%) of the people were female and about half (53%) were male. Most (80%) were White, about 15% were Asian, about 4% were Black, and less than 1% were Native Hawaiian or other Pacific Islander. About 6% of the people in these studies identified as Hispanic or Latino.
In the studies that evaluated Skyrizi in people with active Crohn’s disease:
- Everyone had already tried at least one other medicine that works directly on the body’s immune system. About one-quarter (23%) had tried and failed at least one oral medicine and about three-quarters (75%) had tried and failed at least one injectable medicine.
- About one-third (31%) of the people were using oral corticosteroids when the study started.
- Anyone who was using an oral corticosteroid or other oral medicine before the study started was told to keep using these medicines during the study. Anyone who was using an injectable medicine to treat their condition had to stop that medicine during the study.
- Skyrizi was compared with a placebo, and no one knew whether they were receiving the medicine or the placebo.
In the study that evaluated Skyrizi in people who were in remission:
- Everyone was already using Skyrizi when the study started.
- During the study, some people kept using Skyrizi and others were switched to the placebo. No one knew whether they were receiving the medicine or the placebo.
All of these studies evaluated efficacy by counting the number of people who were in remission, which means that they no longer had any noticeable symptoms. The studies also counted the number of people who had something called an “endoscopic response,” which meant that the swelling in their intestines improved by at least 50% from when the study started.
What Benefits Were Seen in These Studies?
Treating active disease. In two of the studies, everyone had an active disease when the study started. After 3 months, the people who used Skyrizi were more likely to be in remission than the people who used the placebo. Just under half (42%-45%) of the people who used Skyrizi went into remission, compared with about one-quarter (20%-25%) of people who used the placebo.
The people who used Skyrizi were also more likely to have an endoscopic response, which means they had at least 50% less swelling in their intestines. About 29%-40% of people who used Skyrizi had this response, compared to about 12% of people who used the placebo. People who used Skyrizi also reported more improvement in their symptoms, such as stool frequency and stomach pain, than the people who used the placebo.
Keeping people in remission. In one study, everyone was already in remission and already using Skyrizi when the study started. During the study, some people were switched to the placebo and others kept using Skyrizi. The people who kept using Skyrizi were more likely to stay in remission and maintain their endoscopic response after a full year in the study. This happened for about 36%-38% of people who used Skyrizi, compared to about 16% of people who used the placebo.
How Quickly Will Skyrizi Work for Crohn’s Disease?
If Skyrizi is working, your symptoms will start to improve over the first 3 months. Do not stop using this or any other medicines for Crohn’s disease 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 3 months of using Skyrizi. They may discuss other options for treating this condition.
How Do I Use It?
Skyrizi is a liquid that is injected into the body. When you first start using this medicine, you will receive an IV for the first three doses, which will be given every 4 weeks. These first three doses will be given by a health care provider in a health care facility.
After the third dose, you will get shots under the skin. Once you have been trained by your health care provider, you or a caregiver will be able to give these injections at home. The first shot under the skin will be given 4 weeks after the last IV dose. Then, you will use a dose every 8 weeks.
Skyrizi comes in a prefilled cartridge that must be placed into a special device called an on-body injector. This device is intended to be used only one time. This means that a new on-body injector will need to be used for each dose.
The prefilled cartridge is stored in the refrigerator. To make the injection more pleasant, you should take the medicine out of the refrigerator for 45-90 minutes before use. If the liquid inside of the cartridge is cloudy or contains flakes or large particles, it should not be used. Once the cartridge has warmed to room temperature, it is placed into the on-body injector. It is important to start the injection within 5 minutes of placing the cartridge into the device.
Once you have inserted the cartridge and activated the device, it should be placed on the stomach or the front of the thigh using the sticky strips found on the device. Once the injector has been firmly placed on the body, the injection is started by pressing the start button until it clicks. At this point, you may feel a pinch as the needle enters the skin. It will take about 5 minutes for the entire dose to be delivered by the injector.
Your prescription will come with detailed “Instructions for Use,” which provide step-by-step guidance on how to use the on-body injector. It is important to follow each of these steps very closely to ensure that you get the full dose of your medicine each time. Ask your pharmacist or other health care provider if you are unsure how to use the Skyrizi cartridge and on-body injector.
How Can I Prevent or Manage Side Effects?
Skyrizi can cause a skin reaction where you get the shot, which may involve redness, pain, itching, and swelling. To help reduce the risk of this happening, don’t use the on-body injector over any skin that is already tender, damaged, bruised, or scarred.
People who use Skyrizi are more likely to have infections, especially in 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 (800-332-1088).
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 “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 as little as $5 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.skyrizi.com/skyrizi-complete/gastro/rebate.
