Crohn's disease is a chronic inflammatory condition that affects the digestive tract. Research has shown that in Crohn's disease, the body overproduces a substance known as tumor necrosis factor alpha (TNF-alpha). REMICADE works by neutralizing the biologic activity of this substance, which is an important cause of the inflammation processes of Crohn's disease. Because REMICADE neutralizes the TNF-alpha, patients may experience a reduction in their signs and symptoms of Crohn's disease.

REMICADE has been shown in medical studies to improve the visual appearance of the lining of the intestine, and a single dose has been shown to provide benefits for 8 to 12 weeks, on average.

What Is TNF-Alpha?

TNF-alpha is a substance that circulates in the bloodstream and plays an important role in the inflammatory process. Overproduction of TNF-alpha may lead to some diseases associated with inflammation, such as Crohn's disease and rheumatoid arthritis. Because REMICADE blocks TNF-alpha in Crohn's disease patients, it is sometimes called an “anti-TNF-alpha antibody.”

So What Does REMICADE Do in the Body?

In Crohn's disease, the body produces more TNF-alpha than the body's natural receptors can lock onto.

REMICADE helps control the symptoms of Crohn's disease by binding to TNF-alpha and neutralizing its action. REMICADE may also work by altering the function of the immune cells involved in Crohn's disease.

Is REMICADE Right for You?

Your doctor may decide that REMICADE is an appropriate treatment option for you. Although results may vary, REMICADE is 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. When given as a three-infusion course of therapy, REMICADE is also indicated for treatment of patients with fistulizing Crohn's disease for the reduction in the number of draining fistulas.

The safety and efficacy of therapy for fistulizing Crohn's disease continued beyond 3 doses have not been established.

REMICADE is not a cure for Crohn's disease. But for many patients, it can lessen the impact of Crohn's disease and help them return to more normal, active lives.

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 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. 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 disease that affects the nervous system, or if you 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.

What Makes REMICADE Different?

The body produces antibodies in response to foreign substances. Each type of antibody targets a specific substance and attempts to destroy it to prevent it from making you sick. Using what is known about the benefits of antibodies, scientists developed REMICADE to work with your body's own defense system.

REMICADE was specifically designed to target TNF-alpha, a key regulator of inflammation in Crohn's disease. That inflammation causes the pain and diarrhea associated with Crohn's disease. When REMICADE comes in contact with a TNF-alpha molecule, the TNF-alpha is neutralized so it can't continue the inflammation process.

So instead of treating existing inflammation, REMICADE limits symptoms by preventing further inflammation. And unlike drugs that suppress the body's overall inflammation response, REMICADE neutralizes a specific protein that has been implicated in Crohn's disease. Crohn's drug may stop working due to antibodies.

Updated July 2003