Remicade (infliximab)

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Approval Status:

Approved February 2002

Specific Treatments:

Rheumatoid arthritis

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General Information

Remicade, administered through intravenous infusion, has been approved for improvement in physical function for individuals suffering from rheumatoid arthritis (RA). This recent approval is in addition to previous approvals for inhibiting the progression of structural damage and for reducing signs and symptoms of RA. The drug indicated for the treatment of Crohn's disease as well and is the only biologic drug approved for these two conditions. Remicade is also the first drug approved for this most recent indication. For RA treatment, Remicade is to be used in combination with methotrexate, a standard treatment for RA. The combination treatment is given six to eight times per year.

RA is a debilitating, chronic disease that affects more than two million Americans. This autoimmune disease causes the body's immune system to attack multiple joints, leading to pain, swelling and eventually to irreversile joint damage.

Clinical Results

The approval of Remicade for improvement in physical function compromised by RA is supported by a two year double-blind, placebo-controlled study that evaluated changes in physical function due to treatment with Remicade and methotrexate, compared to methotrexate alone. The primary endpoint of the trials, which included 428 subjects, was the changes in physical function and disability from baseline to study end.

Those who received Remicade and methotrexate experienced statistically significant improvement compared to those adminstered only methotrexate. Improvements were evident after 54 weeks of treatment and were sustained through out the entire 102 weeks.

Side Effects

Adverse events associated with the use of Remicade may include (but are not limited to) the following:


  • Upper respiratory infection
  • Cough
  • Sinusitis
  • Headache
  • Rash
  • Abdominal pain

Mechanism of Action

Remicade (infliximab) is a chimeric monoclonal antibody that targets and binds to tumor necrosis factor alpha (TNF-a). TNF-a is a key factor in regulating the inflammation in RA. By inactivating TNF-a, the inflammatory process is significantly diminished from the start.

Additional Information

For additional information on Remicade, please visit Remicade.