REMICADE® (infliximab) is a chimeric monoclonal
antibody that binds to tumor necrosis factor alpha (TNF-a),
which is believed to be a central causative factor in the inflammatory
process in humans.1
On August 24, 1998, the FDA approved REMICADE for the treatment of moderately to severely active Crohn's disease for the reduction of signs and symptoms, in patients who have had an inadequate response to conventional therapy, and for the treatment of patients with fistulizing Crohn's disease for the reduction in the number of draining enterocutaneous fistula(s). It is the first and only FDA-approved product indicated for this serious gastrointestinal disorder.2
On November 10, 1999, FDA approval was granted for the use of REMICADE in combination with methotrexate for the reduction in signs and symptoms of rheumatoid arthritis in patients who have had an inadequate response to methotrexate alone. REMICADE is the first monoclonal antibody to reduce the signs and symptoms of this crippling disease.
On December 29, 2000, the FDA granted Centocor approval to market 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.
The approval of the most recent indication - inhibiting the progression of structural damage - was based on 54-week data from the two-year ATTRACT trial (Anti-TNF Trial in Rheumatoid Arthritis with Concomitant Therapy) involving 428 patients at 34 centers in North America and Europe. Patients treated with REMICADE, in combination with methotrexate, were compared to those patients treated with methotrexate plus a placebo.3
In the ATTRACT trial, progression of joint damage was measured radiographically using the van der Heijde modified Sharp scoring system, which evaluates changes in joint-space narrowing and bone erosions. Among all REMICADE treatment groups, the overall median change from baseline for total radiographic scores (erosions and joint-space narrowing) was 0.0 among patients treated with the combination of REMICADE plus methotrexate (n=285) compared to a median change of 4.0 for patients treated with methotrexate alone (n=64). A total of 53 percent of REMICADE patients demonstrated no deterioration in their total van der Heijde modified Sharp score at 54 weeks. The patients treated with methotrexate plus placebo demonstrated progression comparable to that previously reported for patients with established rheumatoid arthritis treated with methotrexate.
There are reports of serious infections, including sepsis and tuberculosis, that may be life-threatening. So, if you are prone to or have a history of infections, currently have one, or develop one while taking REMICADE, tell your doctor right away. Also tell your doctor before beginning treatment if you have had recent close contact with, or if you have had past exposure to people with tuberculosis, or if you have any other reason to believe you may be at risk. There are also reports of serious infusion reactions with hives, difficulty breathing, and low blood pressure. If you have a de-myelinating disease such as multiple sclerosis, tell your doctor before you are treated. In rare cases, people with de-myelinating disease who were treated with REMICADE have seen their symptoms intensify. Up to one in four people experienced the following side effects in clinical studies: upper respiratory infections, headache, cough, sinusitis, nausea, or mild reactions to the infusion such as rash or itchy skin.