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21 Nov 2008

New analyses reinforce efficacy of Remicade in treatment of severe psoriasis

- 2 Feb 2007
By Centocor, Inc.   
Page 5 of 8

In the SPIRIT trial, the percentage of patients with one or more AE was higher in the REMICADE groups compared with placebo. Through week 30 of the SPIRIT trial, 63 percent, 78 percent and 79 percent of patients in the placebo, REMICADE 3 mg/kg and 5 mg/kg groups, respectively, reported one or more AE. The most commonly reported side effects versus placebo were upper respiratory tract infection (15 percent versus 14 percent), headache (15 percent versus 8 percent) and itching (12 percent versus 0 percent). A total of six percent of REMICADE-treated patients reported serious AEs, compared with zero patients in the placebo group. Overall, the AEs were consistent with those seen in previous trials. Please see "Important Safety Information" below.

About Psoriasis

Psoriasis is a chronic, immune-mediated disease, which results from inflammation in the skin and overproduction of skin cells that accumulate on the surface causing red, scaly plaques that may itch and bleed. This chronic inflammation is driven in part by tumor necrosis factor alpha, or TNF-alpha, a cytokine involved in the body's normal immune response. TNF-alpha is found at increased levels in psoriatic plaques and plays a crucial part in their formation and continued existence. It is estimated that two percent of the U.S. population has psoriasis, and about 30 percent of people with psoriasis have cases that are considered moderate to severe.

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About REMICADE

 
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