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news.The FDA has extended its approval for Centocor's Remicade to include inhibiting progression of structural damage and improving physical function in patients with psoriatic arthritis, in addition to reducing signs and symptoms of active arthritis.
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The extended approval is based on one-year data from a double-blind, placebo-controlled trial named IMPACT 2 and two-year data from a double-blind, placebo-controlled trial named IMPACT. Findings from IMPACT 2 showed that, at week 24, Remicade (infliximab)-treated patients had less structural damage as assessed radiographically compared with patients receiving placebo. In addition, Remicade-treated patients were more than twice as likely to achieve a clinically meaningful improvement in physical function compared with patients receiving placebo (54% vs. 22%, respectively).
“The study findings supporting this approval show that treatment with infliximab can slow the progression in joint destruction often associated with this disease,” said Dr Arthur Kavanaugh, professor of medicine at the University of California at San Diego and lead study investigator. “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.”
The approval adds to Remicade’s already impressive regulatory trophy cabinet. The drug was first approved in 1998 for Crohn’s disease, and has since been granted several approvals in psoriatic arthritis indications, including a recent European Commission approval in active and progressive psoriatic arthritis in patients who have responded inadequately to disease-modifying anti-rheumatic drugs.