Remicade® Reduces Pain Associated With Crohn's Disease

REMICADE® (infliximab), the only biologic approved for the treatment of Crohn's disease, was found to reduce pain
associated with the disease. According to a new sub-analysis from the ACCENT I (A Crohn's disease Clinical trial Evaluating
infliximab in a New long-term Treatment regimen) trial patients who received a three-dose induction regimen of REMICADE®
experienced a significantly greater reduction in pain as assessed by four different pain questions after ten weeks, compared
with patients who received a single dose of REMICADE®.


REMICADE® is the only biologic indicated for reducing signs and symptoms and inducing and maintaining clinical remission in
patients with moderately-to-severely active Crohn's disease who have had an inadequate response to conventional therapy.
REMICADE® is also indicated for reducing the number of draining enterocutaneous and rectovaginal fistulas and maintaining
fistula closure in patients with fistulizing Crohn's disease.


"In previous analyses of ACCENT I and ACCENT II, REMICADE® has been shown to have an impact on the reduction or elimination
of steroid usage associated with Crohn's disease, mucosal healing, even a reduction in the need for surgeries and
hospitalizations," said Dr. Gary Lichtenstein, director of the Center for Inflammatory Bowel Disease, University of
Pennsylvania. "This analysis from the ACCENT I trial further examines the benefit of REMICADE® to patients with Crohn's
disease, with respect to pain measures from indices used to assess this debilitating condition."


REMICADE® is a monoclonal antibody that specifically targets and binds to tumor necrosis factor-alpha (TNF-alpha) on the cell
membrane and in the blood. Overproduction of TNF-alpha is believed to play a role in rheumatoid arthritis (RA) and Crohn's
disease (CD) and in a wide range of Immune-Mediated Inflammatory Disorders (I.M.I.D.) in which REMICADE® is currently being
studied.


About the ACCENT I Sub-analysis


The ACCENT I Trial randomized 573 moderately-to-severely active CD patients to receive one of three different treatment
regimens of REMICADE® during the 54-week trial. ACCENT I utilized three composite questionnaires to evaluate disease activity
in CD patients. This analysis explored the impact of REMICADE® treatment on four pain independent questions (one in each of
the CDAI and Inflammatory Bowel Disease Questionnaire (IBDQ), and two in the SF- 36), which were compared between the
single-dose (5mg/kg IV at week zero) and the three-dose (5 mg/kg at weeks zero, two and six) REMICADE® induction regimens.



Among the patients randomized as responders at week two, the median reduction at week ten was significantly greater in the
three-dose regimen (p 0.05) than in the single-dose regimen in abdominal pain and cramps ratings (from the CDAI) over a
seven-day period (70 percent versus 57 percent), in abdominal pain (from the IBDQ) over a one-week period (40 percent versus
25 percent), in bodily pain (from the SF-36) over four weeks (25 percent versus zero percent), and in the extent to which
pain interfered with normal work (from the SF-36) over four weeks (33 percent versus 25 percent). A benefit was also observed
when comparing the two groups based on all randomized patients. There was a reduction compared with baseline in each
treatment group at weeks ten, 30 and 54 in all four pain measures.















In clinical trials, 26 percent of Crohn's disease patients receiving REMICADE® experienced abdominal pain reported as an
adverse event. However, there was an insufficient number of patients not receiving REMICADE® to make a meaningful comparison.



About Crohn's Disease


Crohn's Disease is a chronic inflammatory bowel disorder that commonly affects the lower part of the small intestine and the
large intestine and typically begins in late childhood or early adulthood. The disease causes inflammation of the
gastrointestinal tract, typically resulting in symptoms such as diarrhea, fever, abdominal pain and weight loss. It is
estimated that 500,000 Americans and more than 400,000 people in Europe and Canada suffer from this gastrointestinal
disorder.


About REMICADE®


REMICADE® is the global market leader among anti-tumor necrosis factor alpha (TNF-alpha) therapies and the only agent
approved for the treatment of both RA and Crohn's disease in North America, the European Union and Japan, and was the first
biologic approved for ankylosing spondylitis in the European Union. In the EU, REMICADE® is indicated for the treatment of
ankylosing spondylitis in patients who have severe axial symptoms, elevated serological markers of inflammatory activity and
who have responded inadequately to conventional therapy.


In September, the European Commission gave approval for expanded labeling for REMICADE®, in combination with methotrexate,
for the treatment of active and progressive psoriatic arthritis in patients who have responded inadequately to disease
modifying anti-rheumatic drugs.


REMICADE® is unique among available anti-TNF biologic therapies. Unlike self-administered therapies that require patients to
inject themselves frequently, REMICADE® is the only anti-TNF biologic administered directly by caregivers in the clinic or
office setting. In RA and CD patients, REMICADE® is a two-hour infusion administered every eight weeks, following a standard
induction regimen that requires treatment at weeks zero, two and six. As a result, REMICADE® patients may require as few as
six treatments each year. The safety and efficacy of REMICADE® have been well established in clinical trials over the past 12
years and through commercial experience with more than a half million patients treated worldwide.


Important Information


Many people with heart failure should not take REMICADE®; so prior to treatment you should discuss any heart condition with
your doctor.


Tell your doctor right away if you develop new or worsening symptoms of heart failure (such as shortness of breath or
swelling of your ankles or feet.)


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 have latent (inactive) TB, your doctor should begin TB
treatment before you start REMICADE®. REMICADE® can lower your ability to fight infections, so if you are prone to or have a
history of infections, or develop any signs of an infection such as fever, fatigue, cough or the flu while taking REMICADE®,
tell your doctor right away. Also tell your doctor if you have lived in a region where histoplasmosis or coccidioidomycosis
is common. Blood disorders have been reported, some fatal. Tell your doctor if you develop possible signs of blood disorders
such as persistent fever, bruising, bleeding or paleness while taking REMICADE®. Nervous system disorders have also been
reported. Tell your doctor if you have or have had a disease that affects the nervous system, or if you experience any
numbness, weakness, tingling or visual disturbances while taking REMICADE®.


Reports of lymphoma (a type of cancer) in patients on REMICADE® and other TNF blockers are rare but occur more often than in
the general population. Tell your doctor if you have or have had cancer. Serious infusion reactions have been reported with
REMICADE®, including hives, difficulty breathing and low blood pressure. Reactions have occurred during or after infusions.
In clinical studies, some people experienced the following common side effects: respiratory infections (that may include
sinus infections and sore throat), coughing and stomach pain or mild reactions to infusion such as rash or itchy skin.
(Please read accompanying patient information sheet.)


About Centocor, Inc.


Centocor, Inc., 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. The company is dedicated to the research and development of
treatments for a wide range of diseases including cancer, infectious diseases, cardiovascular and metabolic diseases and
Immune-Mediated Inflammatory Disorders (I.M.I.D.), such as arthritis and inflammatory skin diseases. Centocor's products,
developed primarily through monoclonal antibody technology, help physicians deliver innovative treatments to improve human
health and restore patients' quality of life. Centocor, Inc., is a wholly owned subsidiary of Johnson & Johnson, the
worldwide manufacturer of health care products.


Centocor, Inc., discovered REMICADE® and has exclusive marketing rights to the product in the United States. Schering-Plough
Corporation has rights to market REMICADE® in all countries outside of the United States, except in Japan and parts of the
Far East where Tanabe Seiyaku, Ltd., markets the product.


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