What is the mechanism of action of Stelara and how does it work?

Stelara is a biologic medicine that targets proteins, enzymes and other molecules in your body that cause inflammation, pain and destruction. Stelara works by targeting immune system proteins called interleukin (IL)-12 and IL-23 to help lower inflammation.

Interleukins are made by white blood cells. They help to fight infection in the body and regulate the immune system. These interleukin proteins are thought to contribute to long-lasting inflammation in conditions like Crohn’s disease, plaque psoriasis, psoriatic arthritis and ulcerative colitis. Stelara helps to address this inflammation and relieve symptoms by blocking interleukin.

Stelara is not a steroid, but is classified as a human interleukin-12 and interleukin-23 antagonist (interleukin inhibitor). Like steroids, it can still suppress your immune system and lead to a great risk of infections, so it's important to follow your healthcare provider's directions.

Uses for Stelara

Stelara is approved by the FDA to treat:

• Plaque psoriasis (moderate to severe) in patients 6 years and older who are candidates for phototherapy or systemic therapy.
• Psoriatic arthritis (active) in patients 6 years and older.
• Crohn’s disease (moderately to severely active) in adults.
• Ulcerative colitis (moderately to severely active) in adults.

How are Stelara injections given?

Stelara is given as an initial intravenous (IV) or subcutaneous (under the skin) injections (for induction), depending upon your medical condition. Thereafter, the medicine is given as a subcutaneous maintenance injection.

Your dose is based on your weight, so your doctor will tell you how much to use and how often. Your healthcare provider can teach you or a caregiver how to give the injections at home for added convenience.

Crohn’s disease and ulcerative colitis

• Stelara is given as an intravenous (IV) infusion into a vein with a needle for the first dose for Crohn’s disease and ulcerative colitis. This injection is given by a healthcare provider.
• Then, it is administered as a subcutaneous injection (under the skin with a needle) every 8 weeks thereafter.

Plaque psoriasis and psoriatic arthritis

• Stelara is given initially as a subcutaneous injection for the first dose, and then again 4 weeks later.
• Then it is administered as a subcutaneous injection (under the skin with a needle) every 12 weeks thereafter.

You can learn to give the subcutaneous injections so you may administer them at home. The subcutaneous injections are given in your stomach area (abdomen), buttocks, and upper legs (thighs). Your doctor will determine your dose, which is based on your weight.

Stelara comes as a 45 mg or 90 mg single dose prefilled syringes for subcutaneous injection or as a 45 mg prefilled single dose vial. It is available from specialty pharmacies and can be mailed to your home or delivered to your doctor. Most people receive their first dose at the doctor’s office.

For intravenous use, Stelara also comes in a 130 mg single dose vial, for use by your healthcare provider.

Learn more: Do I qualify for the Stelara copay card and how much can I save?

The most common side effects will vary based on your clinical condition, but may include:

• Nasopharyngitis (common cold)
• Headache
• Stomach pain
• Flu
• Fever
• Diarrhea
• Itching
• Sinusitis
• Lung infections
• Yeast infections
• Urinary tract infections (UTIs)
• Fatigue / Tiredness
• Injection site reactions
• Nausea / Vomiting

These are not all the possible side effects that may occur with Stelara. If you have questions about side effects, contact your healthcare provider right away.

Related: Side effects, warnings and precautions with Stelara

Related questions

• What does psoriasis look like?
• How do you get psoriasis and is it contagious?
• How does Tremfya work?

How fast does Stelara work?

Stelara starts working right away, but how fast it relieves your symptoms depends upon the medical condition being treated, how well you tolerate the medicine, and your individual response.

While most people respond well to Stelara, not everyone will have a positive effect.

Crohn’s disease

8 weeks

Overall, clinical response and remission in people with Crohn’s disease were found to be significant as early as Week 3 in people who received Stelara and continued to improve through Week 8.

In clinical studies, a greater proportion of patients treated with Stelara had significant relief from their Crohn's disease symptoms compared to placebo (an inactive treatment) at 6 and 8 weeks.

About 34% to 56% of people had relief at 6 weeks after receiving the single intravenous (IV) induction dose of Stelara (compared to 21% and 29% in the placebo group).

At 8 weeks, 21% and 40% of people receiving Stelara went on to remission, compared to 7% and 20% in the placebo group. Remission is when your symptoms are either reduced or disappear, but it does not mean you are cured.

44 weeks

At 44 weeks (52 weeks from the first dose), 59% of patients receiving Stelara exhibited a clinical response compared to 44% receiving a placebo. A clinical remission was achieved by 53% using Stelara and 36% on placebo.

In addition, at Week 44, 47% of patients receiving Stelara were corticosteroid-free and in clinical remission, compared to 30% of patients in the placebo group.

Most patients who had reached remission at the start of the maintenance therapy were able to maintain that status: 67% Stelara compared to 46% in the placebo group.

Plaque psoriasis

Adults

In an adult clinical study, 70% (7 out of 10 people) using Stelara for plaque psoriasis saw at least 75% clearer skin at 12 weeks (compared to 3% to 4% receiving a placebo).

In addition, at week 12, 60% (6 out of 10 people) had their plaque psoriasis rated as cleared or minimal at 12 weeks (compared to 4% receiving placebo).

Children

In a 12-week study in children 12 to 17 years of age with plaque psoriasis, 81% saw at least 75% clearer skin at 12 weeks (compared to 11% of children receiving a placebo). The proportion of children seeing 90% clearer skin was 61% of those using Stelara and 5% on the placebo.

At 12 weeks, 69% of children had their plaque psoriasis rated as cleared or minimal (compared to 5% receiving placebo).

Psoriatic arthritis

In studies, about 50% of people (1 out of 2) taking Stelara experienced a 20% improvement in their joint symptoms (like pain, swelling and stiffness) at 24 weeks. In addition, about 60% (6 out of 10 people) saw at least 75% clearer skin.

More people achieved a 20% or 50% improvement in their joint symptoms and more people had at least 75% clearer skin in the Stelara groups than the placebo groups.

Ulcerative colitis

In studies, over half of patients (52% to 64%) saw relief from ulcerative colitis symptoms by 8 weeks, with 20% of patients (1 out of 5) reaching clinical remission compared to 7% in the placebo group.

At one year, 45% of patients (about 4 out of 10) receiving Stelara were in remission, compared to 26% receiving a placebo. About 43% were in steroid-free clinical remission (26% placebo).

At 2 years, 70% of patients (7 out of 10) had no rectal bleeding and fewer daily bowel movements.

This is not all the information you need to know about Stelara (ustekinumab) for safe and effective use and does not take the place of your doctor’s directions. Review the full product information and discuss this information and any questions you have with your doctor or other health care provider.