BioCentury
ARTICLE | Company News

EMEA guidance on TB in Remicade users

January 2, 2001 8:00 AM UTC

The EMEA has issued recommendations for the use of Centocor's Remicade infliximab, in response to 28 worldwide post-marketing reports of tuberculosis (TB) infection in patients receiving the chimeric anti-TNF-alpha monoclonal antibody. Most patients had a prior history of treatment with immunosuppressants and corticosteroids, and the onset of active TB occurred after three or less infusions of Remicade, supporting a possible relationship with the start of Remicade therapy, EMEA reported. The agency said that before starting treatment with Remicade, patients should be evaluated for active and inactive TB. If active TB is suspected, Remicade treatment should be discontinued until the diagnosis is ruled out or the infection has been treated. In addition, patients should be advised to seek medical attention if any signs of TB are noted including chronic cough, low-grade fevers, and weight loss. In December, Johnson & Johnson (JNJ) subsidiary Centocor issued a letter to physicians in Europe advising evaluation of patients for TB risk prior to starting infliximab therapy. Infliximab has been marketed in the U.S. to treat Crohn's disease since August 1998 and to treat rheumatoid arthritis (RA) in patients who have failed DMARDs since November 1999. It has been marketed in Europe to treat Crohn's disease since August 1999 and was approved in June 2000 for RA. About 100,000 patients have been treated worldwide with Remicade, according to the EMEA. ...