Stelara for Psoriasis and Psoriatic Arthritis

Stelara (ustekinumab) is an injected biologic drug approved by the U.S. Food and Drug Administration (FDA) for the treatment of moderate to severe plaque psoriasis or psoriatic arthritis in adults.

Plaque psoriasis and psoriatic arthritis are both autoimmune disorders in which the immune system inexplicably attacks cells in the upper layer of skin (known as the epidermis). The autoimmune assault triggers inflammation, causing the skin cells to rapidly multiply and form plaques. Over time, the inflammation can also affect joints, causing pain, stiffness, and a loss of the range of motion.

Stelara works by tempering the autoimmune-induced inflammation. In September 2016, Stelara was also approved for the treatment of Crohn's disease.

Stelara is a monoclonal antibody. This is a type of drug manufactured in the lab that is identical to immune cells called antibodies. Antibodies work by activating the immune response and releasing inflammatory substances, called cytokines, into the bloodstream. While inflammation is a natural part of treating acute infections, long-term inflammation can be damaging to cells.

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

Stelara is intended for adults 18 and over. It is used to treat moderate to severe psoriasis in people who are unable to achieve control with topical medications. As an injected biologic drug, Stelara is typically used when psoriasis does not respond to oral medications like methotrexate.

Stelara can also be used with or without methotrexate for people with psoriatic arthritis. In severe cases (such as a rare complication known as arthritis mutilans), Stelara may be used in first-line combination therapy.

Stelara is administered as a subcutaneous (under the skin) injection. The dose varies based on body weight, as follows:

• For adults 100 kilograms (220 lbs) or less, the recommended dose is 45 milligrams (mg) initially and four weeks later, followed a 45-mg injection every 12 weeks.
• For adults over 100 kilograms, the recommended dose is 90 mg initially and four weeks later, followed a 90-mg injection every 12 weeks.

Stelara is available in 45-mg and 90-mg single-use, prefilled syringes. It is also offered in 45-mg and 90-mg single-use vials.

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

The most common side effects (affecting at least one percent of users) include:

• Colds
• Upper respiratory infections
• Headaches
• Fatigue
• Diarrhea
• Dizziness
• Back pain
• Itchiness
• Muscle aches

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 identified.

Stelara should not be used in people with a known hypersensitivity to ustekinumab or any of the 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 accumulative effect may leave you vulnerable to a wider range of serious infections. The drugs are not contraindicated for use with (and may, in fact, be beneficial when prescribed correctly). But, they should be prescribed and 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)

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 should not be used during an active infection whether it be bacterial, viral, fungal, or parasitic. According to premarket studies issued by the FDA, serious infections occurred in 0.9 percent of Stelara users.

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

There have yet to be any well-controlled studies investigating the use of Stelara during pregnancy. The drug is currently classified as Pregnancy Category B, meaning that animal studies have not shown any evidence of fetal harm.