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 methotrexate treatment.
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 methotrexate alone.
The most common adverse events observed in clinical trials included (but are not limited to) the following:
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 Information)
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