REMICADE

May 21, 2002

I know very little about Remicade. It's a laboratory-created

(monoclonal) antibody to one of the major cytokines, TNF-alpha. Some

immune-mediated disorders are associated with a high level of TNF-

alpha, most commonly rheumatoid arthritis (other disorders, like

lupus, curiously has a low level of TNF-alpha, perhaps related to

genetic rather than immunologic reasons).

Remicade has some wicked side effects, so I wouldn't think it's a

good candidate for even severe rosacea. Also, I associate TNF-alpha

with various forms of arthritis, although that may not be a fair

association. But the spondyloarthropathies describe below include

arthritis-type disorders.

This reads like a press release put out by the drug company. That

doesn't make it inaccurate, but puts it in perspective. If I hear

anything more or different, I'll let you all know.

Marjorie

Marjorie Lazoff, MD

> 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.

May 21, 2002