This article is part of the Arthritis Archives.
Dateline: November 15, 1999
Remicade Approved For Rheumatoid Arthritis
The Food and Drug Administration (FDA) has approved the use of Remicade (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 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.
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.
Full prescribing information and more information regarding warnings and precautions can be found at www.remicade.com.
Remicade will be 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.
Remicade is now available to wholesalers with an average price of $611.33 per vial. The average rheumatoid arthritis patient will require 2 or 3 vials per infusion. Since Remicade is an infused drug it meets the necessary criteria for Medicare reimbursement.
Sources: FDA Approves Remicade For RA, PRNewswire, November 10,1999; FDA Approves Arthritis Treatment, AP, November 10,1999
First published: 11/15/1999