Home » Drug Information » FDA Approved Drugs » 2002
Medical Areas: Musculoskeletal | Rheumatology | Family Medicine
View By:YearCompanyConditionsTherapeutic AreasDrug Names
The following drug information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
Company: Centocor Ortho Biotech
Approval Status: Approved February 2002
Treatment Area: Rheumatoid arthritis
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.
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.
Adverse events associated with the use of Remicade may include
(but are not limited to) the following:
- Upper respiratory infection
- 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
For additional information on Remicade, please visit