Stelara for Psoriasis and Psoriatic Arthritis

Stelara (ustekinumab) is an injected biologic drug used to treat moderate to severe plaque psoriasis and active psoriatic arthritis.

Stelara helps psoriasis by tempering the autoimmune-induced inflammation underlying the condition. This autoimmune response causes skin cells to multiply rapidly and form psoriatic plaques. It also affects joints, causing pain, stiffness, and a loss of range of motion.

This article discusses Stelara for psoriasis. It explains how Stelara works, potential side effects, and dosing information. It also provides information on the cost of Stelara and assistance programs available from the manufacturer.

How Can Stelara Help Psoriasis?

Stelara helps treat psoriasis by acting on the underlying cause: a misfiring autoimmune system.

Plaque psoriasis and psoriatic arthritis are both autoimmune disorders that affect the skin. Both occur when the immune system inexplicably attacks cells in the upper layer of skin (epidermis).

Antibodies activate the immune response unnecessarily and release inflammatory substances, called cytokines, into the bloodstream. This leads to long-term inflammation that can be damaging to cells.

Stelara is a monoclonal antibody—a type of drug manufactured in the lab to counteract the immune response that causes the disease.

Stelara works by suppressing two specific cytokines—interleukin 12 (IL-12) and interleukin 23 (IL-23). Both play a key role in inflammatory diseases like psoriasis and psoriatic arthritis.

How Quickly Does Stelara Work for Psoriasis?

Stelara starts working on your immune system after the first dose. Individual results vary, but in general, Stelara improves plaque psoriasis after three months and psoriatic arthritis after six months.

In clinical trials, 60% of plaque psoriasis patients achieved clear or nearly clear skin after 12 weeks, and 70% of patients had at least 75% improvement.

For psoriatic arthritis, after 28 weeks, about half saw a 20% improvement in joint pain, tenderness, inflammation, and functioning. Roughly one-quarter of patients achieved a 50% improvement in symptoms, while only about one in 10 had at least a 70% improvement.

Who Can Take Stelara?

Stelara is approved by the Food and Drug Administration (FDA) for people ages 6 years and older with moderate to severe plaque psoriasis who have tried topical or oral medications without success.

Stelara can be used with or without methotrexate in people ages 6 and older with psoriatic arthritis. In severe cases—such as arthritis mutilans, a rare complication—Stelara may be used in first-line combination therapy.

Stelara is also approved for the treatment of Crohn's disease and ulcerative colitis.

Dosage and How Often Stelara Is Given for Psoriasis

Stelara is administered as a subcutaneous (under the skin) injection. It is available in 45-milligrams (mg) and 90-mg single-use, prefilled syringes. It is also offered in 45-mg and 90-mg single-use vials.

The adult dose for treatment of psoriasis and psoriatic arthritis varies based on body weight as follows:

• For adults 220 pounds (100 kilograms) or less: 45 mg initially and four weeks later, followed by a 45-mg injection every 12 weeks
• For adults over 220 pounds: 90 mg initially and four weeks later, followed by a 90-mg injection every 12 weeks

Stelara Side Effects

As with any other drug, there are side effects associated with Stelara use. Many are the result of immune suppression, which may leave you vulnerable to certain infections.

The most common side effects (affecting at least 3% of users) include:

• Colds
• Upper respiratory infections
• Headaches
• Fatigue
• Diarrhea
• Dizziness
• Back pain
• Itchiness
• Muscle aches
• Redness at the injection site
• Stomach pain
• Vomiting

Less commonly, Stelara can cause the reactivation of tuberculosis (TB). Prior to treatment, people should be tested for TB and treated if an infection is detected.

Anaphylaxis (a whole-body allergic reaction) and angioedema (sudden swelling, often due to allergy) were not reported in any of the premarket studies but have since been seen in isolated cases.

If this occurs, stop taking Stelara and call your healthcare provider immediately. If left untreated, anaphylaxis can lead to shock, coma, respiratory or heart failure, and death.

Interactions

Stelara should not be used in people with a known hypersensitivity to ustekinumab or any of the drug's inactive ingredients. Anyone with a previous reaction should not be rechallenged no matter how mild the reaction may have been.

Stelara should be used with caution with other immune-suppressive drugs. The cumulative effect may leave you vulnerable to a wider range of serious infections.

The drugs are not outright contraindicated for use with Stelara. They may, in fact, be beneficial when prescribed correctly). But they should be prescribed and carefully managed by the rheumatologist overseeing your care.

Among the medications of special concern:

• Cyclosporine
• Decadron (dexamethasone)
• Imuran (azathioprine)
• Medrol (methylprednisolone)
• Methotrexate
• Prednisone
• Prograf (tacrolimus)
• Rapamune (sirolimus)

Who Shouldn't Use Stelara

Stelara should not be used if you have an active infection of any sort, as it suppresses the immune response and makes it harder for the body to fight back.

According to premarket research issued by the FDA, serious infections occurred in 0.9% of Stelara users as a result of the drug's immunosuppressive effects.

This is not a complete list of contraindications. Speak with your healthcare provider about whether Stelara is right for you.

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Other Considerations

Because your immune system is actively suppressed by Stelara, you will need to avoid certain live-attenuated vaccines. These are vaccines made with deactivated but still living viruses. If used, the vaccine may actually instigate the disease it was meant to prevent.

The vaccines you need to avoid without exception include:

• Adenovirus types 4 and 7, live (oral)
• Herpes zoster vaccine, live
• Influenza virus vaccine quadrivalent, live
• Influenza virus vaccine trivalent, live
• Measles (rubeola) vaccine
• Measles, mumps, and rubella (MMR) vaccine, live
• Poliovirus vaccine, live (oral)
• Rotavirus vaccine, live (oral)
• Rubella vaccine
• Smallpox vaccine, live
• Varicella-zoster vaccine, live
• Yellow fever vaccine
  

Moreover, people should not receive the Bacille Calmette-Guerin (BCG) vaccine, used to prevent TB, one year prior to treatment or for one year after Stelara has been stopped.

Stelara may also increase the risk of certain cancers, especially squamous cell skin cancer. With that being said, it doesn't appear to "cause" cancer but rather may promote cancer growth in people with pre-existing risk factors. Anyone treated with Stelara should be monitored for non-melanoma skin malignancies.

Stelara Cost and Discounts

Unfortunately, this not an inexpensive treatment. A single 90 mL pre-filled syringe of Stelara can cost in excess of $25,000 without insurance. That equals one dose of Stelara for psoriasis in a person weighing more than 220 pounds or two doses for people under 220 pounds.

Even with insurance, which is likely to require pre-authorization, the copay for Stelara can be around $1,500 per dose.

Most people require up to six doses in the first year of treatment, then four times a year thereafter. The per-dose price must be multiplied appropriately to get the total cost of using Stelara.

Prescription drug discounts are available for Stelara. Manufacturer Janssen Pharmaceuticals offers the Stelar WithMe Savings Program. Eligible participants with private insurance can pay as little as $5 for the medication.

State-sponsored cost-savings programs can help reduce the cost of medication for people on Medicaid.

The Johnson & Johnson Patient Assistance Foundation may be able to help reduce the cost of the drug for people without insurance. Assistance is based on income and household size.

Is Generic Ustekinumab Available?

Stelara, the brand name for ustekinumab, has been on the market in the U.S. since 2009. It is currently not available in a generic formula.

However, Janssen's patent for ustekinumab is due to expire in September 2023. Pharmaceutical companies around the globe are working to bring generic ustekinumab to the market.