Ustekinamub (Stelara)

Ustekinamub (Stelara) is approved as a treatment for psoriasis. But it is used off-label for Crohn’s disease. Stelara works by blocking cytokines that are important to the inflammatory process in Crohn’s disease. One study showed that 70% of Crohn’s disease patients respond to Stelara.
History
Ustekinumab (Stelara) was approved by the FDA as a treatment for psoriasis, another autoimmune condition, in 2009. Numerous studies have shown that  Stelara is an effective treatment for Crohn’s disease.
Gastroenterologists have been using Stelara off-label to treat Crohn’s disease for several years. FDA approval is expected soon.
How does Ustekinumab (Stelara) work?
Ustekinumab (Stelara) works by blocking the activity of interleukins 12 and 23, cytokines that are important in the inflammation. People with IBD usually have an overabundance of interleukins 12 and 23.

How is it administered?

Stelara is administered as a subcutaneous injection. The second injection is given four weeks after the initial injection. After that, the injections are given every eight weeks.

When will I feel better?

One study of Crohn’s disease patients showed that approximately 70% of people experienced clinical response after 22 weeks.

Stelara Side effects

  • Infections (17­%–22% of patients affected). As with all medications that suppress the immune system, there is an increased risk of infection during treatment with Stelara. Symptoms of infection include chills, fever, cough, sore throatand night sweats. Talk to your care team if think you may have any infection. Your Stelara injection may need to be rescheduled.
  • Redness at the injection site (2%).
  • Headache (5%)
  • Dizziness (2%)
  • Increased risk of cancer. Medications that affect the immune system can increase your risk for developing cancer, though this is very rare. Certain types of skin cancer in people with risk factors for skin cancer have been reported.
  • Reversible Posterior Leukoencephalopathy Syndrome (RPLS). RPLS is a rare condition that affects the brain. The cause is not known. If RPLS is found early and treated, most people recover. Tell your care team right away if you have any new or worsening medical problems, including headaches, seizures, confusion, or visual defects of any kind.
  • Patients taking Stelara should avoid getting “live” vaccines

How long do I need to take Stelara

Ustekinumab (Stelara) is designed to be taken as maintenance treatment to treat and prevent flares of your disease. You may need to take the drug for many years, even during the times when you are feeling well. By taking the medication, you increase the chances of the disease not getting worse.

Studies have shown that the rates of adverse events remain stable over time, and no new side effects developed with increased length of exposure to the medication.

Taking Stelara while Pregnant

Women planning to become pregnant should discuss their treatment choices with their care team. It is generally advised that you continue to take your maintenance treatment throughout pregnancy. Flares can be harmful to the fetus, and maintenance treatment can keep flares from happening.

In animal studies, ustekinumab (Stelara) has been associated with miscarriages. We don’t have human data on the miscarriage risk. Stelera should be used during pregnancy only if the potential benefit outweighs the possible risks.