TB's links to TNF inhibitors
The European Medicines Evaluation Agency has issued recommendations for the use of Centocor Inc.'s Remicade infliximab in patients with Crohn's disease and rheumatoid arthritis (RA), following 28 worldwide reports of serious tuberculosis (TB) infections in patients treated with infliximab (see BioCentury Extra, Tuesday Jan. 2).Centocor Inc. is a subsidiary of Johnson & Johnson (JNJ, New Brunswick, N.J.).
The EMEA's action late last month followed a November report by the FDA at the American College of Rheumatology meeting that analyzed infection rates for Remicade and Enbrel etanercept, a soluble TNF receptor from Immunex Corp. (IMNX, Seattle, Wash.) that inhibits TNF-alpha and is approved to treat rheumatoid arthritis. The infliximab-related TB cases involved a high percentage of unusual presentations involving extrapulmonary TB and miliary TB, which involves hematogenous spread of the bacterium with seeding of multiple organs. ...