Stelara is a biologic medicine used to treat moderate to severe Crohn’s disease and ulcerative colitis. Crohn’s disease and ulcerative colitis are inflammatory bowel diseases that cause inflammation in parts of the digestive tract. They commonly cause diarrhea, belly pain, blood in the stool, and weight loss.
Stelara was approved in 2016 to treat Crohn’s disease and in 2019 for ulcerative colitis. It was the first biologic medicine that targets interleukin (IL)-12 and IL-23. Stelara contains the active ingredient ustekinumab.
According to studies, some people who take Stelara can achieve remission (free from noticeable symptoms) after one dose. Some people are also able to stop using oral steroid medicines.
How Does It Work?
Stelara is a monoclonal antibody that reduces inflammation. It targets specific proteins that cause gut inflammation in people with Crohn’s disease and ulcerative colitis.
How Do I Take It?
Stelara is a liquid that is injected into the skin. After the initial infusion, which is done at your health care provider's office, you will receive a shot every eight weeks.
If you are injecting Stelara yourself, your health care provider will show you how to use it. Be sure to read the instructions carefully. Stelara can be injected into the upper arm, stomach, thigh, or buttocks. Only a caregiver or health care provider can give Stelara in the upper arms. An instructional video is available on the drugmaker’s website at https://www.stelarainfo.com/crohns-disease/patient-resources/. Your health care provider or pharmacist can answer any questions you have.
How Was It Studied for Crohn’s Disease?
Three trials were done that looked at the safety and efficacy of Stelara for Crohn’s disease. People in these studies were over the age of 18, with an average age between 37 and 39. Forty-four percent of the people were male. No racial breakdowns of people in the studies were provided.
In the first study, people had received one or more TNF antagonist medicines and either did not respond, the response was not maintained, or they had unacceptable side effects. In the second study, people had received glucocorticoids or immunosuppressants and had either treatment failure or unacceptable side effects.
In both studies, people received either a single infusion of Stelara, a weight-based dose, or a placebo. They could then go on to take part in the maintenance study. In this study, they received either a shot every eight weeks, one every 12 weeks, or a placebo for 40 weeks. They were allowed to continue taking immunosuppressants, mesalamine, antibiotics, and oral glucocorticoids throughout the study.
All three studies measured the response to treatment based on the Crohn’s Disease Activity Index (CDAI) score. The CDAI score is a tool used to measure how severe Crohn’s disease is, with higher scores meaning the disease is more severe. The CDAI score is as follows:
- 0 to 149: Remission
- 150 to 220: Active but mild disease
- 221 to 450: Moderate to severe disease
- 451 to 600: Severe disease
Clinical response was measured as a decrease in the CDAI score by at least 100 points or a total score of less than 150 (remission). Average scores at the beginning of the study ranged from 302 to 327.
What Are the Benefits Based on Studies for Crohn’s Disease?
Quick results. Some people noticed an improvement within three weeks of starting treatment with Stelara.
Remission. More people taking Stelara were able to achieve remission than those taking the placebo. At the end of the yearlong study, 53% of people taking Stelara reached remission, vs. 36% who took the placebo.
Steroid-free remission. More people using Stelara were able to achieve remission without the use of oral glucocorticoid medicines.
Lasting remission. A five-year extension study showed that 34% of people using Stelara were able to maintain remission for five years.
How Was It Studied for Ulcerative Colitis?
Two studies were done to look at the safety and efficacy of Stelara on people with ulcerative colitis. People in these studies were over the age of 18, with an average age of about 42. Sixty-one percent of people were male.
People in these studies had tried previous therapies and had an unacceptable response or had side effects that were bothersome. They were allowed to continue taking aminosalicylate and immunomodulating medicines. Corticosteroids were discontinued after eight weeks.
People received either a single infusion of Stelara, a weight-based dose, or a placebo. If they responded to the first treatment, they were permitted to go to the maintenance phase of the trial, where they received Stelara every eight or 12 weeks or a placebo for 40 more weeks.
The response to the treatment was measured by the Inflammatory Bowel Disease Questionnaire (IBDQ) and the Mayo Score. The IBDQ is a 32-item questionnaire about the impact of ulcerative colitis on their life. The Mayo Score is a scale ranging from zero to 12, with a higher score meaning a more severe disease. The Mayo Score assesses:
- Rectal bleeding
- Frequency of bowel movements
- Health care provider assessment
- Endoscopy findings
Clinical remission was defined as a Mayo Score of less than two and subscores less than one. The average Mayo Score at the beginning of the study was about nine.
What Are the Benefits Based on Studies for Ulcerative Colitis?
Quick results. Some people had symptom relief starting at eight weeks of treatment.
Clinical remission. At one year of treatment, 44% of people taking Stelara were in remission, compared to 24% who were on a placebo.
Steroid-free remission. People taking Stelara were able to discontinue steroids sooner than those taking a placebo. At 44 weeks, 97% of people in remission were steroid-free.
Improvement in quality of life (QOL). People taking Stelara had their QOL scores improve, while those taking a placebo had their QOL scores worsen.
How Long Does It Take to Work?
In studies for Crohn’s disease, some people saw an improvement in symptoms at three weeks. In ulcerative colitis studies, some people showed improvement in symptoms at eight weeks. Some people are able to achieve remission with one treatment of Stelara, while it may take longer for others. Talk to your health care provider if you don’t notice an improvement by week 16.
How Can I Prevent and Manage Side Effects?
The most common side effects seen in studies were infections, headache, belly pain, and reactions where the needle went in.
Infections were commonly seen in studies, including the common cold, yeast infections, bronchitis, urinary tract infections, and sinusitis. Before you start treatment, your health care provider should check you for tuberculosis. Tell your health care provider if you currently have tuberculosis or have a history of tuberculosis. They should also review your vaccine history to make sure you are up to date on vaccines.
Be sure to eat a healthy diet, get proper rest, and exercise regularly. Clean frequently touched areas, wash your hands often, and avoid touching your face. Avoid sharing personal items, food, and drinks. Tell your health care provider right away if you have signs of an infection.
Headaches frequently occur with Stelara. Talk with your pharmacist or other health care provider for tips on how to manage them, including advice on over-the-counter (OTC) pain relievers that may help.
Mild injection site reactions commonly occur with Stelara. Symptoms include redness, itching, and swelling. Reactions usually go away within a few days. Allowing the medicine to come to room temperature before injecting may help reduce reactions. Make sure you are using a different injection site each time. You can apply a cold compress after the injection to help lessen discolored skin. Tell your health care provider if the symptoms don’t go away within a few days, the injection site looks infected, or if you think you are having an allergic reaction.
Although rare, Stelara increases your risk of cancer, including certain types of skin cancer. It is important to protect your skin when outdoors by wearing sunscreen and protective clothing. Tell your health care provider right away if you have:
- Fever or night sweats
- Swollen glands (lymph nodes)
- Coughing
- Sudden weight loss
- New skin growths
- Moles that change color, size, or shape
- A wound that will not heal
This is not a complete list of side effects. Talk to your health care provider if side effects don’t go away or become bothersome. You can report side effects to the FDA at 800-FDA-1088 (800-332-1088).
What Type of Drug Interactions Can Happen?
Stelara can increase your risk of infections, so you should avoid other medications that increase this risk. Tell your health care provider about all medicines you take, including immunosuppressants like tacrolimus.
Chronic inflammation, seen in Crohn’s disease and ulcerative colitis, can suppress a group of enzymes called CYP450. Some medicines are metabolized by these enzymes. If you take a CYP450 substrate medicine, your dosage may need to be adjusted when starting or stopping Stelara. Ask your pharmacist or other health care provider if any of your medicines are CYP3A4 substrates.
Live vaccines should be avoided while taking Stelara. Stelara can decrease the effect of live vaccines, and you may be at risk of infection. Your health care provider will review your vaccination history and make sure you are up to date on vaccines before starting Stelara.
Stelara can decrease the effect of allergy shots and make you more likely to have an allergic reaction, including anaphylaxis. Tell your health care provider if you get allergy shots.
This is not a complete list of interactions. Tell your health care provider about all the prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, or other supplements you take or have recently taken. This will help them know if there are any interactions or if you need your dose changed.
What Do I Need to Do to Get It?
Stelara is a specialty medicine, which is only available at select pharmacies. These pharmacies will coordinate the delivery of your medicine. Stelara may require a prior authorization from your insurance. Your health care provider will work with your insurance to get Stelara covered for you.
Is There Any Cost Assistance Available?
Eligibility depends on your current prescription and medical coverage.
There is a savings program that can help with out-of-pocket costs for commercially insured people. You may pay as little as $5 per dose. Visit stelarawithme.com or call 844-494-8463 for more information.
If you have questions about cost, insurance coverage, or any other questions about Stelara, you can contact the drugmaker at 800-526-7736.