Stelara for psoriasis: Dosage, efficacy & more

Psoriasis is a skin condition that causes irritation, redness, and silvery scales. Most individuals with psoriasis have plaque psoriasis, which is when the silvery scales appear in patches. Up to 42% of patients with psoriasis also have psoriatic arthritis, a type of arthritis that affects people with psoriasis. Psoriatic arthritis often affects one side of the body, causing joint stiffness and pain. Some people with psoriatic arthritis also have swelling of the eyes or tendons. 

Stelara is an injectable prescription drug containing the active ingredient ustekinumab. It is a biologic medication and monoclonal antibody made by the pharmaceutical company Janssen Biotech. Stelara works by blocking proteins in the immune system that cause inflammation. 

The Food & Drug Administration (FDA) has approved Stelara to treat:

• Adults and children ages 6 and older with moderate to severe plaque psoriasis who may benefit from systemic therapy (in the form of injections or pills that affect the whole body) or phototherapy (UV light treatment)
• Adults and children ages 6 and older with active psoriatic arthritis
• Adults with moderate to severe Crohn’s disease
• Adults with moderate to severe ulcerative colitis

This article focuses on the use of Stelara for psoriasis. 

Stelara as a treatment for psoriasis

People with psoriasis have an overactive immune system. Stelara works by blocking two proteins, interleukin-12 and interleukin-23, which are associated with inflammation. By blocking these proteins, Stelara helps reduce inflammation that causes skin and joint problems.

Let’s look at some of the clinical trials for Stelara. 

A clinical trial called PHOENIX-1 studied the efficacy and safety of Stelara in people with psoriasis. This study found:

• By week 12, 67% of patients who took Stelara 45 milligram (mg) injections had at least a 75% improvement in psoriasis area and severity.
• By week 12, 67% of patients who took Stelara 90 mg had at least a 75% improvement in psoriasis area and severity.
• By week 12, 3% of patients who received a placebo (inactive medicine) had at least a 75% improvement in psoriasis area and severity.

In the PHOENIX-2 clinical trial:

• By week 12, 67% of patients who took Stelara 45 mg had at least a 75% improvement in psoriasis area and severity.
• By week 12, 76% of patients who took Stelara 90 mg had at least a 75% improvement in psoriasis area and severity.
• By week 12, 4% of patients who received a placebo (inactive medicine) had at least a 75% improvement in psoriasis area and severity.

There are multiple treatments for psoriasis and psoriatic arthritis. Consult your healthcare provider for more information and medical advice on an appropriate treatment for you. Your provider will take into account various individual factors like your medical conditions, medical history, and the medications you take.

How to use Stelara for psoriasis

Before you start treatment with Stelara, your healthcare provider will evaluate you for tuberculosis infection and closely monitor you for tuberculosis while being treated with Stelara.  

Also, before using Stelara, your healthcare professional will provide proper training to you or your caregiver on the right way to prepare and inject the medication. You should also read the patient information material and Medication Guide and ask your healthcare professional if you have any questions.

Stelara is administered by subcutaneous (under the skin) injection. It can be self-injected into the buttocks, thigh, or abdomen. If a trained caregiver administers the injection, it can also be injected into the upper arm. 

The subcutaneous dosage of Stelara for psoriasis is as follows:

• For adults with psoriasis who weigh 220 pounds or less: The first dose is 45 mg. The second dose of 45 mg is given four weeks later. Then, a dose of 45 mg is given every 12 weeks.
• For adults with psoriasis who weigh more than 220 pounds: The first dose is 90 mg. The second dose of 90 mg is given four weeks later. Then, a dose of 90 mg is given every 12 weeks.
• For adults with psoriatic arthritis: The first dose is 45 mg. The second dose of 45 mg is given four weeks later. Then, a dose of 45 mg is given every 12 weeks.
• For adults with psoriatic arthritis who also have moderate to severe plaque psoriasis and weigh more than 220 pounds: The first dose is 90 mg. The second dose of 90 mg is given four weeks later. Then, a dose of 90 mg is given every 12 weeks. 
• The dosage for pediatric patients (6 to 17 years of age) is based on weight.

Stelara side effects & warnings

According to the prescribing information, the most common side effects of Stelara in people who use it for psoriasis include:

• Common cold (runny or stuffy nose and sneezing)
• Upper respiratory infections (sore throat, cough, sneezing, and stuffy nose)
• Headache
• Fatigue 

Other side effects include diarrhea, back pain, muscle pain, dizziness, and depression. 

Some people will also have injection site reactions (pain, redness, swelling, irritation, or bruising) where the medication is injected. 

People who have symptoms of a serious allergic reaction should seek emergency medical help. These symptoms may include hives, difficulty swallowing or breathing, or swelling of the face, lips, tongue, or throat. 

Other serious side effects and warnings include:

• Infections: Because Stelara acts on the immune system, it can interfere with the body’s ability to fight infection and increase the risk of infection, including pneumonia and tuberculosis, among other serious infections (which may include bacterial, fungal, or viral infections such as gastroenteritis, or stomach flu). You should contact your healthcare provider immediately if you have symptoms of an infection, such as fever, chills, muscle aches, cough, sores on the body, or fatigue. Also, be alert to symptoms of urinary tract infections, such as urinating more frequently or burning when you urinate. 
• Cancers: Stelara increases the risk of developing certain types of cancer. Some individuals who take Stelara and have risk factors for skin cancer have been diagnosed with certain types of skin cancers. Be alert to any skin changes or growths and notify your healthcare provider right away. 
• Posterior reversible encephalopathy syndrome (PRES): This is a rare condition that affects the brain. Several cases of PRES occurred in clinical studies. If found early and treated, most individuals will recover, but it can cause death if not treated. Tell your healthcare provider right away if you have headaches, seizures, confusion, or any vision changes.
• Avoid live vaccines while taking Stelara. Some examples of live vaccines include the measles, mumps, and rubella (MMR) vaccine, varicella, rotavirus, and nasal flu vaccine. You also should not receive a BCG vaccine (a type of tuberculosis vaccine) while taking Stelara or one year before and after taking Stelara. Check with your healthcare provider before getting any vaccines while taking Stelara. Be aware that non-live vaccines may not elicit an immune response strong enough to prevent disease. 

This is not a full list of side effects, and others may occur. Consult your healthcare provider for more information about potential side effects, which can be found in the full prescribing information. 

Who should not take Stelara for psoriasis?

You should not take Stelara if you are allergic to ustekinumab or any ingredient in the medication. 

Also, you should not start taking Stelara if you have any type of active infection.

How much does Stelara cost?

According to the manufacturer’s website, as of March 2022, the list price (price set by the manufacturer) of Stelara 90 mg is $25,497.12 every eight weeks. This price does not include additional pharmacy charges, so the total depends on the pharmacy.

You will likely need to get this prescription medication from a specialty pharmacy. Insurance can help you save on your Stelara cost. Many eligible commercially insured patients can use the STELARA withMe Savings Program to pay as low as $5 per dose of Stelara. Contact the manufacturer for more details and eligibility requirements.

People with Medicare Part D can visit the manufacturer’s website to view the Medicare Resource Guide for more information. You can also see if you are eligible for the Medicare Extra Help program based on income. Individuals with Medicaid can also visit their state’s Medicaid website to find out more about benefits in their state.

People with VA, DOD, TRICARE, and those who do not have insurance can visit JanssenCarePath.com to learn more about financial assistance for Stelara.

If you have explored all options and the cost of Stelara is too high, you can ask your healthcare provider if another treatment may be as effective as Stelara, but less expensive. Many new psoriasis drugs have been approved recently for psoriasis. Some alternative treatment options for Stelara include: 

• Wezlana is a biosimilar to Stelara, meaning that it is highly similar to Stelara and just as safe and effective. Also, Wezlana is approved as an interchangeable biosimilar, which means that if a healthcare provider prescribes Stelara, the pharmacist may dispense Wezlana if state law allows it. Wezlana is not yet available in pharmacies, but when it is available, the price may be significantly lower than Stelara. The FDA also approved a Stelara biosimilar called Selarsdi in April 2024, but the expected date of availability is not yet known.
• Humira (adalimumab), which also has less expensive biosimilars
• Remicade (infliximab), which also has less expensive biosimilars
• Skyrizi (risankizumab-rzaa)
• Taltz (ixekizumab)