Remicade
What is Remicade? Remicade (also known by its generic name infliximab) is a biologic medication approved by the U.S. Food and Drug Administration (FDA) for the treatment of severe plaque psoriasis and psoriatic arthritis. It is also approved for treating rheumatoid arthritis, ankylosing spondylitis (arthritis affecting the spine), Crohn's disease and ulcerative colitis (inflammatory bowel conditions). For more information about biologics as a class of treatment, please see the biologics section.
Key features
- FDA-approved for severe psoriasis and psoriatic arthritis
- Given by three separate, two- to three-hour infusions in a doctor's office during the first six weeks of treatment
- Subsequent infusions administered every eight weeks
- Patients should be screened for latent (hidden) tuberculosis (TB) before taking Remicade
- Long-term side effects still being monitored
How does it work? Remicade blocks tumor necrosis factor-alpha (TNF-alpha), a chemical "messenger" in the immune system that signals other cells to cause inflammation. There is too much TNF-alpha in the skin of people with psoriasis and the joints of people with certain types of arthritis, such as psoriatic arthritis. TNF-alpha can also lead to increased immune system activity through the activation of T cells. T cells are a type of white blood cell in the body; in psoriasis, once T cells are mistakenly activated, they can trigger inflammation and other immune responses and fuel the development of psoriasis lesions. Remicade helps lower the amount of TNF-alpha to more normal levels, thus interrupting the inflammatory cycle of psoriasis and psoriatic arthritis and leading to improvement in symptoms for many people who take it.
Who is a candidate? Remicade is prescribed for people with severe psoriasis and active psoriatic arthritis.
Who should not take Remicade?
- People with active serious infections or a history of recurrent infections
- People with a history of heart failure
- People with multiple sclerosis or other types of demyelinating neurologic diseases
- Children—the medication has not been approved for children
Caution is advised for people who experience any numbness or tingling, or have ever had a disease that affects the nervous system. Caution is also advised for the elderly, due to the already increased risk of infection for this age group. The impact of Remicade on pregnant women or developing fetuses is not known, nor is it known if the medication passes into breast milk in nursing women. Remicade should only be given to pregnant or nursing women if there is a clear medical need, and if this decision is reached by a patient and doctor together. Pregnant women using Remicade should talk to their doctor about enrolling in a pregnancy registry.
How is it used? Remicade's treatment regimen for severe plaque psoriasis and psoriatic arthritis calls for patients to receive 5 mg per kg in three infusions in a doctor's office during the first six weeks of treatment. During an infusion, the patient sits in a chair and the medication is administered by IV in the course of about two to three hours. After the first three treatments, patients continue to receive Remicade infusions at regular intervals of eight weeks, depending on the individual patient, how well symptoms are being managed and the disease severity.
What are the side effects? Remicade has been on the market since 1998 and has been used by more than one million patients worldwide. Therefore, more is generally known about its safety and its short- and long-term side effects than is known about some of the newer biologic medications. In studies of rheumatoid arthritis and Crohn's disease patients, the most common side effects reported were: - infusion reactions (fever, chills, rash)
- upper respiratory infections
- headache
- coughing
- stomach pain
- sore throat
- itching
These side effects are generally mild and did not cause most patients to stop taking Remicade. These events happened most often after the first Remicade infusion and may decrease after additional infusions. TB, invasive fungal infections and other serious infections have been reported in Remicade patients; some of the infections have been fatal. The infections often occurred in patients who were also using other medications that suppress the immune system. Remicade treatment should not be started in someone with an active infection, and is usually not recommended for someone with a history of recurring infections. People taking Remicade should be monitored for signs of infection, and if a serious infection develops, the medication should be stopped. People should be evaluated for hidden TB infections by getting a TB skin test prior to treatment with Remicade. Doctors may also order a chest X-ray before starting treatment. Hidden TB must be treated first, before people can begin taking Remicade. There have been rare reports of central nervous system disorders in association with the use of Remicade. Doctors are advised to use caution in considering the use of Remicade in patients with preexisting or the recent onset of central nervous system disorders, including multiple sclerosis. It has been shown that Remicade may worsen existing heart failure. Therefore, Remicade should not be taken by patients with moderate to severe congestive heart failure, and the dose should be limited for those with any class of congestive heart failure. The FDA has reviewed the association between TNF-alpha medications like Remicade and an increased risk of developing lymphoma, a type of cancer. The FDA concluded there is not enough data to know if these medications contributed to higher risk. Some patients receiving Remicade developed severe liver damage. Doctors are advised to use caution in considering the use of Remicade in patients with liver disease. Remicade's safety and side effects continue to be monitored by Centocor and the FDA. For detailed information on side effects and safety, talk to your doctor.
How do I get Remicade? Remicade is available by prescription, primarily from rheumatologists and gastroenterologists. Dermatologists prescribe it for psoriasis. Once a person and his or her doctor make the decision that Remicade is an appropriate treatment, a determination of insurance coverage will need to be made, and preauthorization from the insurance company will likely be needed. Centocor has a special program where patients and doctors can get help with insurance questions and other issues. For more information, call 1.888.ACCESS.1 (222-3771) or visit www.remicade.com.
How much does it cost? In general, biologics tend to be expensive; the cost of each drug can vary between $10,000 and $25,000 per year (or more), based on the dosage and treatment regimen prescribed by your doctor. Most insurance companies cover this medication for its approved indications: psoriasis, psoriatic arthritis, rheumatoid arthritis, ulcerative colitis, ankylosing spondylitis and Crohn's disease. If a person's health insurance will cover Remicade, the exact amount will vary. Some patients will be fully covered for Remicade; others may be partially covered or, in some cases, may have to pay a percentage of the total cost out of pocket.
Centocor has a patient assistance program to help provide discounted medications to people who qualify, based on income levels and other factors. More information about this program can be obtained by calling 866.489.5957 or 1.888.ACCESS.1 (222-3771). Updated February 2008
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