Nov. 10, 1999 (Atlanta) -- The FDA today approved Remicade (infliximab) to be used with methotrexate for treatment of rheumatoid arthritis. In clinical trials, Remicade and methotrexate produced significant improvement in rheumatoid arthritis patients compared with those on methotrexate and placebo. Remicade was first approved in August 1998 as a treatment for Crohn's disease, an inflammatory bowel disease.
Remicade works by reducing the level of a chemical in the body called tumor necrosis factor alpha. Tumor necrosis factor alpha is a key factor in the inflammatory process that occurs in rheumatoid arthritis and Crohn's disease.
A study of Remicade in more than 400 patients with rheumatoid arthritis was discontinued early due to the dramatic improvement of the patients receiving the treatment after one year. The study's safety monitoring committee felt that the patients in the placebo group were missing an opportunity for significant symptom relief.
Centocor, the manufacturer of Remicade, issued a warning letter last November on a series of serious side effects experienced by patients taking Remicade. Six patients were hospitalized with muscle aches, rash, and fever. The company said the adverse events were attributable to overstimulation of the immune system. All patients fully recovered.
Remicade is given intravenously every two weeks for a total of three doses over a four-week period. It is then given every eight weeks thereafter. Patients generally receive eight infusions during the first year of treatment. In subsequent years, the number of infusions drops to six.
The Arthritis Foundation issued a statement calling the approval a major advance in the treatment of rheumatoid arthritis for patients who have responded inadequately to methotrexate, the current standard treatment. The Arthritis Foundation says that patients with chronic, active, or recurrent infection should be cautious when considering the use of Remicade, due to its suppression of the immune system.