. The FDA approved Remicade for the treatment of psoriatic arthritis in May 2005. Remicade is also approved to treat such diseases as rheumatoid arthritis, ankylosing spondylitis, Crohn's disease and ulcerative colitis.
"The approval of Remicade is a much needed addition for patients living with psoriasis," said Gail Zimmerman, president and CEO of the National Psoriasis Foundation. "Its dual indication gives people who have both psoriasis and psoriatic arthritis another treatment option."
How will people use it?
Remicade's treatment regimen for psoriasis calls for patients to receive 5 milligrams (mg) per kilogram (kg) in an infusion in a doctor's office. During an infusion, the patient sits in a chair or lies on an examination table and the medication is administered by IV in the course of about two to three hours.
Patients receive an additional infusion both two and six weeks after the first infusion and then every eight weeks thereafter.
How effective is Remicade?
In two double-blind, placebo-controlled studies of more than 1,200 patients with chronic plaque psoriasis, researchers monitored skin symptoms.
In the first study, eight out of 10 patients receiving Remicade achieved 75 percent improvement in psoriasis by week 10. Similar results were seen in the second study. Six months into the studies, these results were maintained by maintenance infusions given every eight weeks. The majority of patients who continued on this regimen achieved 75 percent improvement at week 50, the last visit in both studies.
How does Remicade work?
The medicine works by blocking a chemical in the immune system that overstimulates inflammation. This chemical is called tumor necrosis factor-alpha (TNF-alpha), an immune-system chemical messenger. 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.
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.
What are the side effects?
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?
For more information, including prescribing information, please visit our 
