Stelara (Ustekinumab) for People With Crohn's Disease

Stelara (ustekinumab) is a biologic therapy that targets interleukin (IL)-12 and IL-23 cytokines. More technically, it is a fully human monoclonal immunoglobulin antibody that targets the IL-12 and IL-23 shared P40 subunit. Stelara was first approved in 2008 to treat plaque psoriasis and in September 2016 was approved to treat moderate to severe Crohn's disease.

• Stelara is not a cure for Crohn's disease
• Stelara is given first by infusion and then by injections that can be done at home
• People with a current infection shouldn't receive Stelara
• There is an increased risk of infection and any signs of infection should be discussed with a doctor right away
• Stelara hasn't been extensively studied during pregnancy and breastfeeding and a doctor should be consulted right away in the case of a pregnancy
• Patients should be tested for tuberculosis (TB) before starting Stelara

Stelara is different from most another inflammatory bowel disease (IBD) medications in that it is started with an infusion but then continued with injections that are given at home. The first treatment with Stelara is done with an infusion. The drug is given intravenously in an infusion center or in a doctor's office. The amount of Stelara used is individualized and is calculated based on the patient's weight. After that, Stelara is given by subcutaneous injections (an injection given under the skin) every 8 weeks, which can be done at home.

Patients are trained by a nurse or other healthcare professional on how to give the injections. The drug comes in a special injector, which the patient either gives to themselves or has a friend or family member give to them. Patients can inject Stelara in the thigh, abdomen, buttocks, or upper arm.

Stelara may be prescribed to treat moderate to severe Crohn's disease in people over the age of 18. Janssen Biotech, Inc, the manufacturer of Stelara, states that this medication is approved for patients with Crohn's disease who "were intolerant to treatment with immunomodulators or corticosteroids but never failed treatment with a tumor necrosis factor (TNF) blocker, or who failed or were intolerant to treatment with one or more TNF blockers." This means that it is for use in patients who were treated with another type of medication and didn't improve. This could include the immunomodulatory drugs (that suppress the immune system), steroids like prednisone, or a TNF blocker (sometimes called biologics).

Other immune-mediated diseases for which Stelara is approved in the United States include psoriasis and psoriatic arthritis. Stelara is not currently approved by the FDA to treat ulcerative colitis. Stelara is not approved for use in children or teens under the age of 18.

Stelara has been used to treat immune-mediated conditions, with Crohn's disease being the latest disease for which it has been found effective. Stelara blocks interleukin (IL)-12 and IL-23, which are found in the body naturally but are thought to contribute to the inflammation in Crohn's disease. Stelara is not a cure for Crohn's disease.

Tell your doctor if you have or have had any of the following conditions:

• A previous allergic reaction to Stelara
• A latex allergy, because the pre-filled syringe may contain latex 
• Have a recent vaccination with a live vaccine, or a member of your household had a live vaccine
• Have received the bacille Calmette-Guerin (BCG) vaccine because it should not be given within a year of taking Stelara (either before or after)
• Any skin rashes 
• Are currently getting shots for allergies, especially for serious allergic reactions
• Have ever been treated with phototherapy (light therapy)
• Pregnant or breastfeeding, or may become pregnant or plan to breastfeed while taking Stelara
• Have a history of infections or a current infection

The reason why a doctor will need to know about allergy shots and severe allergies is that Stelara can change the way the body reacts to those shots. Stelara might make an allergy shot less effective or increase the risk of having an allergic reaction after receiving the shot. It is vital to work closely with an allergist and a gastroenterologist to reduce the risk of having allergic reactions. Serious allergic reactions to Stelara are rare.

Stelara may increase the risk of developing an infection, including anal abscess, gastroenteritis, ophthalmic herpes, pneumonia, and listeria meningitis. Patients should be vigilant about monitoring for any signs or symptoms of an infection and report them to a physician right away. This includes:

• Abdominal pain
• Cough
• Coughing up blood
• Diarrhea
• Fatigue
• Fevers
• Muscle pain
• Pain or burning while urinating
• Shortness of breath
• Skin rashes
• Sweats
• Unexplained weight loss

There are a few things you should consider before taking Stelar.

Taking Stelar during pregnancy has not been studied extensively. There have been a few accidental pregnancies in women with psoriasis who were taking Stelara. These have all been case reports, which means that it is a single event that is being studied. There haven't been any large scale studies that look at how Stelara affects unborn babies. At least one resulted in a miscarriage, but there has not been enough research to know for certain whether or not Stelara would harm a fetus.

The FDA pregnancy category for Stelara is type B. This means that the effect Stelara has on an unborn child has not been extensively studied. It's currently recommended that Stelara should only be used during pregnancy if clearly needed. The doctor that prescribes Stelara should be contacted immediately if pregnancy occurs.

Because there is so little information about pregnancy and Stelara, anyone who does become pregnant are asked to participate in the pregnancy registry by calling 1-877-311-8972. This can help scientists learn more about how Stelara affects mothers and babies to improve care for other patients in the future.

It is thought that Stelara can pass into breastmilk and therefore be taken in by baby. Nursing a baby while receiving Stelara should be discussed with members of a healthcare team and should be made on an individual basis.

Stelara has been used since 2008 to treat immune-mediated conditions. The latest condition for which Stelara has been approved is Crohn's disease. While Stelara is not a cure, it has been shown to be effective for treating Crohn's disease in some patients.