Remicade Gets Expanded Arthritis Indication

Johnson & Johnson subsidiary Centocor, Inc. received extended approval from the FDA for Remicade for inhibiting progression of structural damage and improving physical function in patients with psoriatic arthritis, in addition to reducing signs and symptoms of active arthritis. The approval is based on one-year data from the double-blind, placebo-controlled IMPACT 2 trial and two-year data from the IMPACT trial. Findings showed that at week 24, Remicade-treated patients had less structural damage as assessed radiographically compared with patients receiving placebo. Remicade-treated patients were also more than twice as likely to achieve a clinically meaningful improvement in physical function compared with patients receiving placebo (54% vs. 22%, respectively).

Remicade was first approved in 1998 for Crohn’s disease and has since been used to treat patients with gastroenterologic, rheumatologic and dermatologic inflammatory diseases.