Centocor's Remicade expanded for inhibiting joint damage, improving physical function

By Elaine Rigoli

Tampa, Fla., Aug. 14 - Centocor, Inc. said Monday that the Food and Drug Administration has extended its approval for Remicade (infliximab) 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 trial Impact 2 and two-year data from the double-blind, placebo-controlled trial Impact.

Findings from Impact 2 showed that at week 24, Remicade-treated patients had less structural damage as assessed radiographically compared with patients receiving a placebo, and Remicade-treated patients were more than twice as likely to achieve a clinically meaningful improvement in physical function compared with patients receiving a placebo (54% versus 22%, respectively).

An immune-mediated inflammatory disease, psoriatic arthritis affects about 1 million men and women in the United States and is often characterized by symptoms of joint inflammation and skin lesions, according to a news release.

First approved in 1998 for Crohn's disease, Remicade has been used to treat more than 770,000 patients worldwide living with gastroenterologic, rheumatologic and dermatologic inflammatory diseases.

"The study findings supporting this approval show that treatment with infliximab can slow the progression in joint destruction often associated with this disease. A significant proportion of infliximab-treated patients showed improvement in physical function in addition to improvement in both joint and skin symptoms, an important treatment outcome in a potentially debilitating inflammatory disease like psoriatic arthritis," said Arthur Kavanaugh, a professor of medicine at the University of California at San Diego and lead study investigator, in a statement.

Centocor, a wholly owned subsidiary of Johnson & Johnson, is a biopharmaceutical company located in Horsham, Pa.

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