Skyrizi (risankizumab-rzaa)

Reviewed by: HU Medical Review Board | Last Reviewed: July 2022 | Last updated: July 2022

Skyrizi® is a biologic drug that was approved in June 2022 to treat Crohn's disease (CD) in adults. Biologic drugs turn down (suppress) the immune system.1

Skyrizi was originally approved for people living with moderate to severe plaque psoriasis and those with active psoriatic arthritis. Researchers then found that it is also effective for those living with moderately to severely active CD.1

CD is an autoimmune disorder that affects the lining of the gastrointestinal (GI) tract. It can affect any part of the GI tract, from the mouth to the anus. In autoimmune diseases, an overactive immune system fights healthy cells as though they are foreign and harmful. One way of treating autoimmune diseases is to suppress the immune system so that it does not fight these healthy cells.2

What are the ingredients in Skyrizi?

The active ingredient of Skyrizi is risankizumab-rzaa.3

How does Skyrizi work?

Skyrizi works on a specific immune system molecule called interleukin 23 (IL-23). There are dozens of interleukins in the body. They work as the immune system’s messengers and regulators. Each sends a different message to different types of cells.4

Interleukins can work to turn down or turn up inflammation. IL-23 is involved in increasing inflammation in autoimmune diseases like psoriasis, psoriatic arthritis, and CD. Skyrizi binds to IL-23 to block it from sending the inflammatory messages that cause Crohn’s symptoms.4

Skyrizi improves the symptoms of CD and heals irritation in the GI tract that can be seen only with a camera inserted into the GI tract (endoscopy). Studies have shown that Skyrizi can improve symptoms in as little as 4 weeks. With consistent dosing, Skyrizi could put Crohn’s symptoms into remission for a year or longer in some people.4

What are the possible side effects?

The most common side effects in the first 12 weeks of taking Skyrizi include:3

  • Upper respiratory infection
  • Headache
  • Joint pain or stiffness (arthralgia)

The most common side effects beyond the first 12 weeks include:3

  • Joint pain or stiffness
  • Injection site reactions such as rash, swelling, itching, and pain
  • Abdominal pain
  • Low red blood cell count (anemia)
  • Fever
  • Back pain
  • Urinary tract infection

The most serious possible side effects of Skyrizi are allergic reaction (anaphylaxis) and infection.3

In some people, biologic drugs such as Skyrizi may have an unintended effect called immunogenicity. This is when the drug causes the immune system to fight the drug, making the drug ineffective. Doctors are not sure exactly why this happens.5

These are not all the possible side effects of Skyrizi. Talk to your doctor about what to expect when taking Skyrizi. You also should call your doctor if you have any changes that concern you when taking Skyrizi.3

Other things to know

The first few doses of Skyrizi are typically given through an IV (intravenously). This occurs at a hospital, infusion center, or doctor's office. After these starting doses, Skyrizi is given with an injection using a small needle under the skin. After training on how to give the drug, you may be able to give it to yourself. Talk to your doctor about your dosing options.3

Skyrizi may not be right for you if you are allergic to the medication, if you are currently sick, or if you have tuberculosis.3

Because biologic drugs turn down your immune system, it is important to be extra cautious about infections. Before taking Skyrizi, your doctor should check you for tuberculosis and any other infections. If you develop a serious infection while on Skyrizi, your doctor may recommend that you stop the drug until the infection is cleared.3

Because of this risk of infection, certain vaccines should not be given when taking Skyrizi. Your doctor may recommend catching up on vaccines before starting Skyrizi.3

Skyrizi was shown to affect liver function in one person during clinical trials. Before starting Skyrizi, your doctor should order blood work that looks at your liver function. If these tests come back abnormal, or if you have cirrhosis, Skyrizi may not be right for you. Your doctor may also check your liver again while you are taking the drug if they have any concerns.3

The safety of Skyrizi in people who are pregnant or breastfeeding has not been established. If you are pregnant, plan to become pregnant, or are breastfeeding, speak to your doctor. It is also important to talk to your doctor if you become pregnant while on Skyrizi.3

Before beginning treatment for CD, tell your doctor about all your health conditions and any other drugs, vitamins, or supplements you are taking. This includes over-the-counter drugs. For more information, read the full prescribing information of Skyrizi.

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