Remicade OK'd for severe plaque psoriasis

Horsham, Pa. - The Food and Drug Administration (FDA) has approved Remicade (infliximab, Centocor) for treating adult patients with chronic severe plaque psoriasis who are candidates for systemic therapy when other systemic therapies are medically less appropriate, the company announced.

The approval is based on results of two phase 3 clinical trials that showed that eight out of 10 patients treated with 5 mg/kg induction therapy achieved 75 percent improvement in skin symptoms as measured by the PASI index after 10 weeks, and significant proportions also achieved a 90 percent improvement or nearly complete skin clearance.

More than 1,200 patients participated in the two trials, the company reports.

Adverse events occurred more frequently in the Remicade groups compared with the placebo groups in both trials. The only clinically significant laboratory abnormalities that occurred more frequently in the Remicade groups compared with placebo groups were elevated liver enzyme tests.

Remicade holds 13 FDA approvals for inflammatory diseases in gastroenterology, rheumatology and dermatology, the company reports.