Company: Centocor
Approval Status: Approved February 2002
Treatment for: Rheumatoid arthritis
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.
