Home » Drug Information » FDA Approved Drugs » 2001
Medical Areas: Endocrinology | Rheumatology | Family Medicine
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The following drug information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
Company: Centocor Ortho Biotech
Approval Status: Approved January 2001
Treatment Area: Rheumatoid arthritis
The FDA has approved Remicade, in combination with methotrexate,
for inhibiting the progression of structural damage in patients
with moderately to severely active rheumatoid arthritis who have
had an inadequate response to methotrexate. Remicade was previously
approved in 1999 for the treatment of signs and symptoms of
rheumatoid arthritis in individuals who have not had success with
Remicade works by blocking the activity of human tumor necrosis
factor alpha (TNFa), a protein that mediates inflammation and
cellular immune response. Elevated levels of TNFa have been
detected in the joints of rheumatoid arthritis patients and are
related to disease activity.
Rheumatoid arthritis is a disabling condition that causes pain,
swelling and severe limitations of movement. Joint inflammation can
destroy cartilage, tendons and ligaments, wear away bone and
subsequently cause joint deformity. While rheumatoid arthritis can
affect people at any age, it occurs most commonly in individuals
ages 25 - 50.
Remicade was evaluated in a multicenter phase III trial called
ATTRACT (Anti-TNF Trial in Rheumatoid Arthritis with Concomitant
Therapy), which included 428 subjects at 34 centers in North
America and Europe. The double-blind, placebo-controlled,
randomized trial was designed to compare the effectiveness of
Remicade in combination with methotrexate versus treatment with
methotrexate plus placebo.
Changes in joint-space narrowing and bone erosion were measured
on a five-point scale using the van der Heijde modified Sharp
system. Fifty-four-week data demonstrated an overall median change
from baseline for radiographic scores of 0.0 among subjects treated
with the combination of Remicade plus methotrexate, compared to a
median change of 4.0 for subjects treated with methotrexate alone.
This result was maintained through two years. The methotrexate-only
findings represent a 7-8% deterioration in radiographic scores.
Additionally, after 54 weeks of therapy, approximately 52% of
subjects who received Remicade and methotrexate experienced a
reduction in the signs and symptoms of rheumatoid arthritis as
measured by ACR 20, compared to 17% of subjects receiving
The most common adverse events observed in clinical trials
included (but are not limited to) the following:
- Upper respiratory infection
Mechanism of Action
Remicade (infliximab) is a chimeric IgG1k monoclonal antibody.
Infliximab neutralizes the biological activity of TNFa by binding
with high affinity to the soluble and transmembrane forms of TNFa
and inhibits binding of TNFa with its receptors. Biological
activities attributed to TNFa include: induction of
pro-inflammatory cytokines such as interleukins 1 and 6,
enhancement of leukocyte migration by increasing endothelial layer
permeability and expression of adhesion molecules by endothelial
cells and leukocytes, activation of neutrophil and eosinophil
functional activity, induction of acute phase reactants and other
liver proteins, as well as tissue degrading enzymes produced by
synoviocytes and/or chondrocytes. (from Remicade Prescribing
Please visit Centocor's product web site for additional
information on Remicade.
For additional information on rheumatoid arthritis, please visit
the Arthritis Foundation.