Stelara (ustekinumab) - What You Should Know

Injectable Drug for Plaque Psoriasis and Psoriatic Arthritis

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Stelara (ustekinumab), an injectable biologic medication, was approved by the U.S. Food and Drug Administration (FDA) on September 25, 2009 for the treatment of moderate to severe plaque psoriasis in adults. Plaque psoriasis, which affects approximately 6 million people in the U.S., is an immune system condition that causes the rapid overproduction of skin cells. Plaque psoriasis is characterized by thickened patches of inflamed, red skin, typically covered with scales that appear silvery.

  Three studies involving 2,266 patients evaluated the safety and effectiveness of Stelara, ultimately leading to its approval for plaque psoriasis.

Four years later, on September 23, 2013, it was announced that the FDA also approved Stelara, alone or in combination with methotrexate, for the treatment of adults patients with active psoriatic arthritis. More than 2 million people in the U.S. have psoriatic arthritis, an autoimmune disease characterized by joint inflammation and joint damage, as well as skin lesions associated with psoriasis. Two pivotal phase III multicenter, double-blind, randomized, placebo-controlled trials (PSUMMIT I and PSUMMIT II) involving 927 patients with psoriatic arthritis evaluated the safety and effectiveness of Stelara and led to its approval.

Janssen Biotrech, Inc. discovered and developed Stelara. The drugmaker holds exclusive marketing rights to the drug in the U.S. The Janssen Pharmaceutical Companies hold exclusive worldwide marketing rights.

What Is Stelara?

Stelara is a monoclonal antibody. More specifically, Stelara is a human interleukin antagonist targeting IL-12 and IL-23, two proteins which are thought to play a role in certain inflammatory conditions, including psoriasis and psoriatic arthritis.

How Is the Drug Administered?

Stelara is administered as a subcutaneous injection (i.e., under the skin).

For psoriasis patients who weigh 220 lbs. (100 kg.) or less, the recommended initial dose and subsequent dose at 4 weeks is 45 mg., followed by 45 mg. every 12 weeks. For patients who weigh more than 220 lbs. (100 kg.), the recommended initial dose and subsequent dose at 4 weeks is 90 mg., followed by 90 mg. every 12 weeks.

For patients with psoriatic arthritis, the recommended dose of Stelara is 45 mg. initially and at 4 weeks, followed by 45 mg. every 12 weeks. For patients who have both plaque psoriasis and psoriatic arthritis and who weigh more than 220 lbs., the recommended initial dose and dose 4 weeks later is 90 mg., followed by 90 mg. every 12 weeks.

Stelara is available in a 45 mg/0.5mL single use, pre-filled syringe and in a 90 mg/mL single use pre-filled syringe. Stelara is also available in single use vials containing either 45 mg/0.5mL or 90 mg/mL of Stelara.

Who Should Not Use Stelara?

People with a known hypersensitivity to ustekinumab or inactive ingredients in Stelara should not use the product.

The inactive ingredients include: L-histidine, L-histidine monohydrochloride monohydrate, polysorbate 80, and sucrose.

Common Side Effects

Common side effects associated with Stelara include nasopharyngitis, upper respiratory infections, headache, and fatigue. Other side effects are possible. Talk to your doctor if you experience any side effects which may be related to Stelara.

Warnings and Precautions

Stelara may increase the risk of infections and reactivation of latent (inactive or dormant) infections.  In clinical trials, serious bacterial, fungal, and viral infections were observed in some patients treated with Stelara. The drug should not be administered to a patient with an active infection and should be considered carefully in patients with a chronic infection or history of serious or recurring infection. Prior to initiating treatment with Stelara, patients should be tested for tuberculosis (TB). Treatment of latent TB should precede treatment with Stelara.

Based on clinical trials, the risk of malignancy may be increased with the use of Stelara. There have also been postmarketing reports of the rapid appearance of multiple cutaneous squamous cell carcinoma in patients treated with Stelara who had pre-existing risk factors for non-melanoma skin cancer. All patients treated with Stelara should be monitored for non-melanoma skin cancer.

Hypersensitivity reactions (e.g., anaphylaxis and angioedema) have been noted in postmarketing reports. If this occurs, appropriate therapy should be given to resolve the hypersensitivity reaction and Stelara should be discontinued.

One case of Reversible Posterior Leukoencephalopathy Syndrome was reported in a patient who received 12 doses of Stelara over two years. The patient did fully recover with proper treatment and the discontinuation of Stelara.

Patients treated with Stelara should not receive live vaccines, nor should anyone in their household. Patients should not receive a BCG (Bacille Calmette Guerin) vaccine for one year prior to treatment with Stelara or for one year after Stelara has been stopped.

There have not been adequate or well-controlled studies of Stelara use in pregnant or nursing women. For it to be used during pregnancy or while nursing, the benefit must outweigh the potential risk to the fetus.

Sources:

Stelara. Prescribing Information. Revised 03/2014.
http://www.stelarainfo.com/pdf/PrescribingInformation.pdf

FDA Approves Stelara. Drugs.com. September 2009.
http://www.drugs.com/newdrugs/fda-approves-stelara-ustekinumab-psoriasis-1667.html

Stelara (ustekinumab) Receives FDA Approval to Treat Active Psoriatic Arthritis. September 2013.
http://www.drugs.com/newdrugs/stelara-ustekinumab-receives-fda-approval-active-psoriatic-arthritis-3903.html

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