NEWS: FDA approves Remicade for psoriatic arthritis treatment

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FDA approves Remicade for psoriatic arthritis treatment

Posted May 19, 2005

Updated May 23, 2005

Centocor, Inc. announced on May 17, 2005, that the U.S. Food and Drug

Administration (FDA) approved a new use for the biologic drug Remicade

(generic name infliximab); it is now approved for helping to reduce the

signs and symptoms of active psoriatic arthritis. The approval marks

the ninth indication for Remicade, which is also approved to treat such

diseases as Crohn's disease, rheumatoid arthritis, ankylosing

spondylitis and ulcerative colitis.

The Psoriasis Foundation welcomes the news as continuing a historic new

era for psoriasis and psoriatic arthritis patients through the

development and approval of appropriate treatments.

" The approval of Remicade is important because of the renewed hope that

this therapy may offer for many people with psoriatic arthritis, " said

Gail Zimmerman, president and CEO of the National Psoriasis Foundation.

How will people use it?

Remicade's treatment regimen for psoriatic arthritis calls for patients

to receive 5 milligrams (mg) per kilogram (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 or lies on an examination table

and the medication is administered by IV in the course of about two

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

being treated.

How effective is Remicade?

In a double-blind, placebo-controlled study of 200 patients with active

psoriatic arthritis, researchers monitored joint symptoms and the skin.

Determining arthritis measurement scores by week 24 in those using 5

mg/kg of Remicade:

* More than half achieved 20 percent improvement

* More than 40 percent achieved 50 percent improvement

* Nearly 30 percent achieved 70 percent improvement

In measurements of psoriasis severity by week 24:

* 75 percent achieved 50 percent improvement

* 60 percent achieved 75 percent improvement

* Nearly 40 percent achieved 90 percent improvement

Remicade was also noted in the study for reducing dactylitis (swollen

finger and toe joints) and enthesopathy (inflammation of a tendon, or

ligament insertion to the bone), two common disease manifestations

causing pain and swelling.

How is Remicade different?

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.

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 happen most often after the first

Remicade infusion and may decrease after additional infusions.

People should be evaluated for latent (hidden) tuberculosis (TB)

infections by getting a tuberculosis skin test prior to treatment with

Remicade. Hidden TB must be treated first, before people can begin

taking Remicade.

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, like methotrexate.

Remicade treatment should not be started in someone with an active

infection, and it may not be 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.

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

pre-existing or the recent onset of central nervous system disorders,

including multiple sclerosis. About 10 percent of patients develop

antibodies to the medication, and these patients are more likely to

have an allergic-type reaction to the infusion.

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. 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 Remicade fact sheet or our section on biologic medications for

psoriasis and psoriatic arthritis.

http://www.psoriasis.org/news/stories/2005/20050519_remicade.php