Stelara (ustekinumab) is a prescription brand-name medication. It’s approved by the Food and Drug Administration (FDA) to treat moderate to severe Crohn’s disease in adults in certain circumstances.
Crohn’s disease is an inflammatory bowel disease. This means that it causes inflammation (damage and swelling) in your gastrointestinal tract.
Here are the basics about Stelara:
- Active ingredient: ustekinumab
- Drug class: monoclonal antibody
- Drug forms: liquid solution for subcutaneous injection or intravenous infusion
- Available as a generic: no
Read on for more information about Stelara and its use in Crohn’s disease treatment. You can also refer to this article for a comprehensive look at Stelara, including its other uses.
Stelara is approved to treat moderate to severe Crohn’s disease in adults in certain circumstances. If your doctor has prescribed Stelara, you may be wondering how it treats this health issue.
The way a drug works is called its mechanism of action. Stelara’s mechanism of action involves stopping certain proteins from causing inflammation (damage and swelling). These proteins are called interleukin-12 (IL-12) and interleukin-23 (IL-23).
They cause inflammation that can lead to symptoms of Crohn’s disease. These proteins also activate other cells in the immune system, which can make Crohn’s disease symptoms worse.
By blocking the action of IL-12 and IL-23, Stelara can reduce inflammation and symptoms of Crohn’s disease.
How long it takes Stelara to work
Stelara begins working to treat Crohn’s disease very soon after your first dose. However, it may take a few weeks before you begin noticing an improvement in your symptoms.
In clinical studies of adults with Crohn’s disease, some people reported an improvement in their symptoms during their third week of Stelara treatment. And in a few cases, people experienced remission within 3 weeks. (Remission means having very few or no symptoms.) However, it can take up to 8 weeks for Stelara to reduce your symptoms.
Stelara is approved to treat moderate to severe Crohn’s disease in adults in certain circumstances. Below, find detailed information about this use of Stelara.
Dosage
To treat Crohn’s disease, Stelara is given as an initial induction dose, then administered again every 8 weeks.
An induction dose is used to get enough medication in your body for the treatment to start working quickly. This is also called a “loading dose.” This first dose of Stelara is given by intravenous (IV) infusion.
Your induction dose is based on your body weight in kilograms (kg). The table below also shows weight approximations in pounds (lb) and the corresponding doses in milligrams (mg).
| Body weight | Induction dose |
| 55 kg (about 121 lb) or less | 260 mg |
| 56 kg to 85 kg (about 121 lb to 187 lb) | 390 mg |
| 86 kg (about 187 lb) or more | 520 mg |
After your induction dose, you’ll have 90 mg of Stelara as a subcutaneous injection every 8 weeks. This is called your maintenance dosage.
Note: In addition to treating moderate to severe Crohn’s disease, Stelara has several other uses. Keep in mind that the drug’s dosages for other uses may differ. To learn more, talk with your doctor.
How to use
Your Stelara induction dose will be given by a healthcare professional as an IV infusion. This may be done at an office or infusion clinic. These infusions usually last at least an hour.
For your maintenance doses, you’ll receive Stelara as subcutaneous injections. These may be given in various areas, including your belly, buttocks, thighs, or upper arms.
A healthcare professional can give you these injections. They may also show you how to give yourself the injections at home.
How often to use
After receiving your induction dose, you’ll have a maintenance dose of Stelara once every 8 weeks.
Stelara may cause side effects that are mild or serious. The lists below include some of the main side effects that have been reported while using Stelara to treat Crohn’s disease.
Side effects of Stelara may vary depending on the condition it’s being used to treat. For information about other potential side effects of the drug, talk with your doctor or pharmacist. You can also see our article about Stelara’s side effects or refer to Stelara’s medication guide.
Note: The Food and Drug Administration (FDA) tracks and reviews the side effects of drugs it has approved. If you would like to notify the FDA about a side effect you’ve had with Stelara, you can do so through MedWatch.
Mild side effects
Like other medications, Stelara can cause mild side effects. When the drug is used to treat Crohn’s disease, mild side effects may include:
- itchy skin
- nausea and vomiting
- diarrhea
- redness at the injection site
- upper respiratory infections, such as the common cold, bronchitis, or sinus infection
- urinary tract infection
- vaginal yeast infection
These side effects of Stelara may be temporary, lasting a few days or weeks. But if they last longer, or if they bother you or become severe, it’s important to talk with your doctor or pharmacist.
Serious side effects
Serious side effects were rare in clinical studies of Stelara, but they can occur.
Talk with your doctor right away if you develop serious side effects while using this drug. If any side effect seems life threatening, or if you think you’re having a medical emergency, call 911 (or your local emergency number) immediately.
Serious side effects of Stelara can include:
- reversible posterior leukoencephalopathy syndrome (swelling in your brain), which is also known as posterior reversible encephalopathy syndrome
- cancer, such as prostate cancer, breast cancer, or colorectal cancer
- serious infections, such as pneumonia
- allergic reaction
You can also refer to this article for a comprehensive look at serious side effects of Stelara.
Below are some frequently asked questions about using Stelara to treat Crohn’s disease.
Stelara vs. Remicade for Crohn’s disease: How do they compare?
Both Stelara and Remicade (infliximab) are approved to treat moderate to severe Crohn’s disease. However, there are some differences in their uses for this condition.
Both Stelara and Remicade can be used in adults who have tried other treatments that weren’t effective. Remicade is also approved for use in children ages 6 years and older.
Stelara requires one initial induction dose,* followed by maintenance doses every 8 weeks. Remicade requires three induction doses* at weeks 0, 2, and 6, followed by maintenance doses every 8 weeks.
Stelara and Remicade may cause some of the same side effects. These may include abdominal (belly) pain and redness at the injection site. The drugs can cause some different side effects, as well.
If you’d like more information about how Stelara and Remicade are alike and different for treating Crohn’s disease, talk with your doctor or pharmacist.
* An induction dose is used to get enough medication in your body for your treatment to start working quickly.
Will Stelara cure my Crohn’s disease?
No, Stelara isn’t a cure for Crohn’s disease. Currently, there isn’t a cure for this condition.
In clinical studies, Stelara was effective at relieving Crohn’s disease symptoms. In fact, some study participants experienced remission, which means that after starting the treatment, they had very few or no symptoms. In these studies, nearly half of the people who received Stelara experienced remission by week 44 of the treatment.
If you have questions about what to expect from Crohn’s disease treatment, talk with your doctor or pharmacist.
In clinical studies of adults with moderate to severe Crohn’s disease, Stelara was effective at relieving Crohn’s disease symptoms. In fact, some people in the studies experienced remission, which means that after starting the treatment, they had very few or no symptoms.
A scoring scale called the Crohn’s Disease Activity Index was used in studies of Stelara. A lower score indicated that Crohn’s disease symptoms are well-managed. Having a score below 150 indicated remission.
At week 8 of the treatment, people who received Stelara had improved scores. And by week 44, nearly half of the people who received Stelara experienced remission.
Crohn’s disease is a type of inflammatory bowel disease. It causes inflammation (damage and swelling) in your digestive tract. Inflammation from Crohn’s disease can affect any part of the tract, but it most commonly affects a part of the small intestine called the ileum.
The exact cause of Crohn’s disease isn’t known. It may be partly caused by your immune system mistakenly attacking your body’s own cells, which leads to inflammation. Usually, the immune system only attacks cells that it considers “foreign,” to protect you from infection.
Symptoms of Crohn’s disease
Crohn’s disease symptoms can vary, depending on the affected part of the digestive tract. Some common symptoms include:
- changes in appetite
- diarrhea
- peptic ulcers
- mouth ulcers
- pain, most commonly in the lower-right side of your abdomen (belly)
- rectal bleeding
- unintended weight loss
Who can use Stelara for Crohn’s disease?
Stelara can be used to treat moderate to severe Crohn’s disease in either of the following groups of people:
- Adults who have tried one or more tumor necrosis factor (TNF) blocker drugs that weren’t effective or caused side effects that couldn’t be managed.
- Adults who have tried immunomodulator drugs or corticosteroids that weren’t effective or caused side effects that couldn’t be managed. These adults must not have had unsuccessful treatment with a TNF blocker.
Before you use Stelara, there’s some important information to keep in mind. The drug may not be safe for you if you have certain medical conditions or other factors that affect your health. Some of these are mentioned below.
If any of the following medical conditions or other health factors are relevant to you, talk with your doctor before using Stelara:
- if you’ve recently received certain vaccinations
- if you have or have had cancer
- if you currently have an infection
- if you have a history of tuberculosis
- if you’re pregnant or breastfeeding
- if you’ve had an allergic reaction to Stelara or any of its ingredients
How much Stelara costs depends on several factors. These can include your prescribed treatment regimen, insurance plan, pharmacy, and location. The overall price also depends on the cost of the appointments to receive Stelara doses from your healthcare provider.
You may still have some questions about using Stelara for Crohn’s disease. Talk with your doctor or pharmacist, who can advise you about whether Stelara might be right for you.
Here are some other helpful references:
- More details. For details about other aspects of Stelara, refer to this article.
- Side effects. To learn more about side effects of Stelara, see this article.
- Drug comparison. To find out how Stelara compares with Cosentyx (secukinumab), read this article. To learn how Stelara compares with Humira (adalimumab), see this article.
- Information about Crohn’s disease. For more information about this and other digestive conditions, see our list of Crohn’s/IBD articles.
Disclaimer: Medical News Today has made every effort to make certain that all information is factually correct, comprehensive, and up to date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or another healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.