What Is Stelara (Ustekinumab)?

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Stelara (ustekinumab) is a type of systemic treatment for people who have psoriasis that is moderate to severe. It was approved by the US Food and Drug Administration in 2009 and is also approved for treating psoriatic arthritis1.

Ustekinumab, the active ingredient in Stelara, is a type of biologic therapy. It is a powerful treatment that affects the way the immune system works to help control the symptoms of psoriasis. Stelara is usually recommended for people whose psoriasis cannot be controlled by topical treatments and who need to try treatment with phototherapy or a systemic therapy2.

Stelara is a maintenance medicine for treating psoriasis, which needs to be taken over a longer period of time to control symptoms effectively. Patients take Stelara in an injection that is usually administered every three months after initial dosing3.

How does Stelara (ustekinumab) work to treat plaque psoriasis?

Psoriasis is a chronic autoimmune condition with symptoms on the skin that are caused by inflammation inside the body. Proteins called cytokines within the immune system are involved in the process of inflammation by activating the T-cells that cause an over-production of new skin cells in people with psoriasis. These new skin cells are created more quickly than older skin cells can be shed, which leads to a buildup of cells on the surface of the skin in the form of psoriasis plaques.

Two types of cytokines that have been linked to psoriasis are interleukin-12 (IL-12) and interleukin-23 (IL-23). Ustekinumab, the active ingredient in Stelara, is a type of biologic therapy called an interleukin 12/23 inhibitor1. It targets and binds to IL-12 and IL-23 proteins, keeping them from activating the T-cells. This can help to reduce inflammation and control psoriasis symptoms.

The results of clinical studies on Stelara suggest that after 12 weeks of treatment, around 70% of patients had improvement in their symptoms of 75% or more. Around 60% of patients had psoriasis that was classified as cleared or minimal after the 12 weeks2.

Who can take Stelara (ustekinumab)?

Stelara is approved for adults aged 18 years and older with moderate-to-severe psoriasis.

People who currently have an infection, including tuberculosis, must be treated and have the infection completely cleared before being treated with Stelara. Patients are given tuberculosis tests before and during treatment with Stelara3.

Before prescribing the medicine, healthcare providers also need to know if the patient3:

  • is being treated with phototherapy, or has ever been treated with phototherapy
  • has any new or changing psoriasis plaques
  • has or has had any type of cancer
  • is allergic to latex
  • is receiving or has ever received allergy shots
  • is pregnant, planning to become pregnant, or breastfeeding
  • is allergic to Stelara or any of its ingredients
  • has any other medical conditions
  • has recently been vaccinated, or is scheduled to have any vaccines

How is Stelara (ustekinumab) administered?

Patients take Stelara as an injection into the upper arm, buttock, thigh, or abdomen. Some patients may be able to inject themselves at home if they are trained by a healthcare provider. It is best to inject the medicine into a different area of skin than the previous injection. Stelara should be refrigerated when not in use.

Most patients will receive the second injection 4 weeks after the first one, and then a single dose every 12 weeks after that. It will usually take around 28 weeks for Stelara to have its full effect3.

What are the possible side effects and risks of taking Stelara (ustekinumab)?

Stelara can reduce your immune system’s ability to fight off infections caused by viruses, fungus, or bacteria. These can be very serious or even life-threatening. Let your healthcare provider know if you develop any symptoms of infection during treatment with Stelara, such as fever, cough, weight loss, or flu-like symptoms4.

Taking Stelara can cause a slight increase in the risk of developing certain types of cancers, such as skin cancer. It can also increase the risk of a very rare condition called reversible posterior leukoencephalopathy syndrome. Healthcare providers will monitor patients for signs of any serious side effects during treatment4.

The side effects that are most frequently reported by patients who take Stelara are:

  • runny nose
  • upper respiratory infections
  • headache
  • tiredness
  • skin reactions where the injection is delivered (such as pain, swelling, itching)

Can Stelara (ustekinumab) be used with other treatments or drugs?

Many patients are able to combine treatment with Stelara with topical medicines and/or methotrexate, another type of systemic medicine3. Healthcare providers will advise patients about which other combinations may be safe for use with Stelara4. More studies are needed to learn about how Stelara may interact with other types of medicines.