 Remicade
Approved For RA By FDA Previous Page
The Food and Drug Administration (FDA) has approved the use of
Remicade(TM) (infliximab) with methotrexate for the treatment of
rheumatoid arthritis in patients who have had an inadequate response to
methotrexate alone. Methotrexate is considered the current standard of
treatment for rheumatoid arthritis.
Remicade is the first monoclonal antibody used to reduce the signs and
symptoms of rheumatoid arthritis and is administered intravenously at
zero, two, and six weeks initially and every eight weeks subsequently.
After the first year, patients are scheduled to receive six infusions a
year.
The approval of Remicade was based on results from the clinical trial
ATTRACT (Anti-TNF Trial in Rheumatoid Arthritis with Concomitant
Therapy), a double-blind, placebo-controlled, randomized clinical trial
involving 428 patients at 34 clinical sites. At week 30 in the study, 50
percent of patients treated with Remicade and methotrexate, compared to
20 percent of patients receiving only methotrexate, exhibited reduced
signs and symptoms of rheumatoid arthritis as measured by a standard
assessment known as ACR20 (a 20 percent reduction in the number of
tender, swollen joints as well as other criteria including physician and
patient global assessments and a laboratory marker of inflammation and
pain) .
Notably, the patients in the ATTRACT trial had a level of disease
considered very difficult to manage or control. The trial participants
had a median duration of disease of 8.4 years and all were taking
methotrexate. About half of the participants had taken methotrexate for
three years or more. Over a third of the participants had prior joint
surgery and about half were classified as functional class 3 or 4
indicating progressive, advanced disease. The first dose of Remicade
given resulted in significant relief and other significantly positive
trial results were reported.
Remicade was previously approved for the treatment of Crohn's disease in
August 1998. Remicade works to reduce inflammation in Crohn's and in
rheumatoid arthritis by binding to and neutralizing TNF-alpha, a
cytokine involved in the inflammatory process.
Since Remicade is an infused drug it meets the necessary criteria for
Medicare reimbursement.
Full prescribing information and more information regarding warnings and
precautions can be found at http://www.remicade.com Remicade is
generally well tolerated and side effects are usually mild however an
FDA warning exists that anti-TNF drugs may result in increased risk of
infection.
Remicade is marketed by Centocor, Inc. and Ortho-McNeil Pharmaceutical,
Inc. in the United States for use in the treatment of rheumatoid
arthritis. Both are Johnson & Johnson affiliates.
REFERENCE:
FDA Approves Remicade For RA, PRNewswire, November 10,1999
FDA Approves Arthritis Treatment, AP, November 10,1999
Disclaimer: no liability whatsoever is accepted for information given
and all such information, especially with regard to drug usage must be
checked with a person's health care provider. No one in the employ of
Dr. David Mandel inclusive of Dr. Mandel, has any affiliation with the
afore mentioned pharmeceutical companies or their subsidiaries. The
information is provided for educational purposes only.
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