Remicade

[Guest guest]

I'm not educated when it comes to immune-mediated disorders, but I

ran across this on the web. Anyone know if meds like these may be

helpful if cea is immune mediated?

REMICADE® (infliximab) Results Reported Across Broad Range Of Immune-

Mediated Inflammatory

Preliminary Data Presented at Annual American College of Rheumatology

Meeting

San Francisco, CA (November 13, 2001) -- A number of investigational

studies on the use of REMICADE® (infliximab) in an array of immune-

mediated inflammatory disorders will be presented this week at the

annual meeting of the American College of Rheumatology (ACR) in San

Francisco. REMICADE® is the only biologic drug currently indicated

for the treatment of rheumatoid arthritis (RA) and Crohn's disease

and has recently become the worldwide market share leader among tumor

necrosis factor alpha (TNF-a) therapies.

REMICADE® data presented encompasses studies in spondyloarthropathies

(SpA), including ankylosing spondylitis (AS). REMICADE® is a

monoclonal antibody that specifically targets and irreversibly binds

to TNF-a on the cell membrane and in the blood. Overproduction of TNF-

a is believed to be associated with the conditions comprising

spondyloarthropathies.

" While these new data are preliminary in nature, they help to assess

the extent to which TNF-a may play a role across a broad spectrum of

debilitating inflammatory diseases and certainly sets the stage for

further investigation, " said Yocum, M.D., professor of

medicine, director, Arizona Arthritis Center.

A total of 82 abstracts will be presented involving treatment with

REMICADE® across a wide range of immune-mediated inflammatory

diseases. A major theme of this year's ACR meeting concerns emerging

information regarding SpAs, with more than 25 abstracts associated

with TNF-a therapies and 15 specifically involving REMICADE®. Results

from two investigational studies supported by Centocor/Schering

Plough are highlighted below.

SPONDYLOARTHROPATHY

Spondyloarthropathies are a group of related disorders with common

clinical, biological and genetic characteristics. Representative SpA

diseases include ankylosing spondylitis, psoriatic arthritis and

reactive arthritis and may include severe inflammation in the eye

(uveitis).

Randomized Double-Blind Comparison of Monoclonal Antibody to Tumor

Necrosis Factor a (infliximab) Versus Placebo in Active

Spondyloarthropathy. The objective of this study was to evaluate

infliximab in the short-term treatment of patients with active SpA.

Forty patients with active SpA were randomized to receive either a

loading dose regimen of infliximab five mg/kg at weeks zero, two and

six, or placebo. Evaluations were performed at weeks one, two, six,

eight and 12. The primary endpoint of the trial was defined as

improvement in patient and physician global assessment of disease

activity based on a 100-mm visual analogue scale. The authors report

that at 12 weeks, patient and physician global assessment of disease

activity improved in the infliximab group, while no improvement was

seen in patients treated with placebo.

ANKYLOSING SPONDYLITIS

AS is a chronic, debilitating disease characterized by progressive

spinal fusion (ankylosis), arthritis and physical deformity.

Treatment of Severe Ankylosing Spondylitis with the Anti-TNF-a

Infliximab in a Placebo-Controlled Multicenter Trial. The primary

objective of this placebo-controlled, multicenter study was to

investigate the efficacy of treatment with infliximab in patients

with ankylosing spondylitis. Seventy patients with active disease,

despite treatment with a non-steroidal anti-inflammatory drug

(NSAID), were randomized to either placebo or infliximab five mg/kg

at week zero, two and six. The authors report that at week 12, the

Bath AS disease activity index (BASDAI), along with other functional

and health-related quality of life measurements, was assessed. Based

on the primary endpoint that defines response as a 50 percent BASDAI

improvement, 53 percent of patients who received infliximab responded

versus nine percent of patients receiving placebo.

About REMICADE® (infliximab)

REMICADE® was the first biologic approved by the FDA for short-term

use in patients with Crohn's disease who have had inadequate response

to conventional therapy. REMICADE® is also indicated, in combination

with methotrexate, for reducing the signs and symptoms and inhibiting

progression of joint damage in patients with moderately to severely

active rheumatoid arthritis that have had an inadequate response to

methotrexate alone.

There are reports of serious infections, including tuberculosis (TB)

and sepsis. Some of these infections have been fatal. Tell your

doctor if you have had recent or past exposure to people with TB.

Your doctor will evaluate you for TB and perform a skin test. If you

are at risk, he or she may begin TB treatment before you start

REMICADE®. If you are prone to or have a history of infections,

currently have one or develop one while taking REMICADE®, tell your

doctor right away. Also tell your doctor if you have lived in a

region where histoplasmosis is common or if you have or have had a de-

myelinating disease such as multiple sclerosis.

There are also reports of serious infusion reactions with hives,

difficulty breathing and low blood pressure. In clinical studies,

some people experienced the following common side effects: upper

respiratory infections, headache, nausea, cough, sinusitis or mild

reactions to the infusion such as rash or itchy skin. For important

product information about REMICADE®, please visit www.remicade.com.

About Centocor

Centocor is a leading biopharmaceutical company that creates,

acquires and markets cost-effective therapies that yield long-term

benefits for patients and the health care community. Its products,

developed primarily through monoclonal antibody technology, help

physicians deliver innovative treatments to improve human health and

restore patients' quality of life. Centocor is a wholly owned

subsidiary of & , the worldwide manufacturer of health

care products.

Centocor has exclusive marketing rights to REMICADE® in the United

States. Schering-Plough Corporation has rights to market REMICADE® in

all other countries throughout the world, except in Japan and parts

of the Far East where Tanabe Seiyaku, Ltd., will market the product.