Patients interested in learning more about the new CD indication may contact a special toll-free hotline (1-866-548-1641) or visit www.remicade.com. With more than three million vials sold and 277,000 patients treated worldwide, REMICADE is the market share leader among tumor necrosis factor alpha (TNF-alpha) therapies and the only biologic indicated for the treatment of both CD and rheumatoid arthritis (RA), a painful and potentially disabling condition that affects more than two million Americans.

Study Design
Patients enrolled in the ACCENT I trial were given a single REMICADE 5 mg/kg infusion. Those who responded at week two were randomly assigned to three treatment groups. One group received placebo at weeks two and six followed by repeat infusions of placebo every eight weeks. The second group received infusions of 5 mg/kg of REMICADE at weeks two and six followed by subsequent infusions at the same dose every eight weeks. A third group received infusions of 5 mg/kg of REMICADE at weeks two and six followed by repeat infusions of 10 mg/kg every eight weeks thereafter. Infusions continued for all treatment groups through week 46. The co-primary endpoints were the proportion of patients who responded at week two and were still in remission at week 30, and the time to loss of response through week 54 in patients who responded. Response and remission were assessed using the Crohn’s disease activity index (CDAI). Response was defined as a decrease of =25% and =70 points in CDAI score. Remission was defined as a CDAI score of less than 150.

Remission-Level Control of Symptoms
Researchers found that 57% of patients (311/545) responded to a single infusion of REMICADE at two weeks of treatment. Among responders, significantly more patients receiving maintenance treatment with REMICADE 5mg/kg achieved clinical remission at week 30 (39%) compared to placebo maintenance patients (25%). Additionally, patients in the REMICADE maintenance groups had a longer time to loss of response than patients in the placebo maintenance group.

Ability to Reduce or Eliminate the Need for Steroids
A significantly greater proportion of patients receiving maintenance therapy with REMICADE were in clinical remission and able to reduce or eliminate steroid use compared to those treated with placebo. At week 54, more than twice as many patients in the REMICADE 5 mg/kg maintenance group were in remission and had discontinued steroid use (25%) compared to patients treated with a single infusion of REMICADE 5 mg/kg followed by placebo (11%).

Improvement in Health-Related Quality of Life
In the ACCENT I trial, the Inflammatory Bowel Disease Questionnaire (IBDQ) and the Short-Form 36 (SF-36) were used to assess disease-specific and health-related quality of life, respectively. The IBDQ and the SF-36 are validated patient-reporting tools. The IBDQ provides relevant data on bowel function and abdominal pain, systemic symptoms, social functioning, and emotional health. The SF-36 is a measurement tool used to assess the physical and mental health status of a patient. At weeks 30 and 54, a significant improvement from baseline was seen among patients in the 5 mg/kg and 10 mg/kg REMICADE treated groups compared to the placebo group in the disease-specific IBDQ, particularly in the bowel and systemic components, and in the physical component summary score of the SF-36.

About REMICADE
REMICADE is a monoclonal antibody that specifically targets and irreversibly binds to TNF-alpha. Overproduction of TNF-alpha is believed to play a role in CD and RA, and may also be important in a wide range of other immune-mediated inflammatory disorders.

In addition to reducing pain and stiffness and inhibiting the progression of structural damage, REMICADE, in combination with methotrexate, is the first and only drug approved by the FDA to improve physical function in patients with moderately to severely active RA who have had an inadequate response to methotrexate alone. REMICADE is the only drug that can address all key elements of RA treatment, as defined by the new 2002 American College of Rheumatology treatment guidelines.

When treating patients with Crohn's disease, the recommended dose of REMICADE is 5 mg/kg given as an induction regimen at zero, two, and six weeks followed by a maintenance regimen at the same dose every eight weeks thereafter. REMICADE is also approved for the reduction in the number of draining enterocutaneous fistulas in patients with fistulizing Crohn's disease. The safety and efficacy of therapy for fistulizing Crohn's disease continued beyond three doses have not been established.

About Crohn's Disease
CD 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. Although corticosteriods have been the first-line therapy for patients with moderate to severe disease, prolonged steroid use can result in a number of serious side effects, including mood swings, cataracts, diabetes, osteoporosis, and hypertension.

Important Information
Many people with heart failure should not take REMICADE; so, prior to treatment, patients should discuss any heart condition with their doctor. Patients should tell their doctor right away if they develop new or worsening symptoms of heart failure (such as shortness of breath or swelling of their feet).

There are reports of serious infections, including tuberculosis (TB) and sepsis. Some of these infections have been fatal. Patients should tell their doctor if they have had recent or past exposure to people with TB. Their doctor will evaluate them for TB and perform a skin test. If a patient has latent (inactive) TB, his or her doctor should begin TB treatment before starting REMICADE. If a patient is prone to or has a history of infections, currently has one, or develops one while taking REMICADE, he or she should tell his or her doctor right away. Patients should also tell their doctor if they have lived in a region where histoplasmosis is common, or if they have or have had a disease that affects the nervous system, or if they experience any numbness, tingling, or visual disturbances.

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. Please read important information about REMICADE, including full prescribing information, at 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 healthcare 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 Johnson & Johnson.

Centocor has exclusive marketing rights to REMICADE in the United States. Schering-Plough Corporation (NYSE:SGP) 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.