REMICADE-Treated Patients Experienced Rapid and Substantial Improvement in Psoriasis in Critical Regio...(e placebo-controlled period) AEsoccurred...),Health

Date:2/4/2008

e placebo-controlled period), AEs occurred at a higher incidence in the REMICADE groups (63 percent and 69 percent with 3 mg/kg and 5 mg/kg, respectively), compared with the placebo group (56 percent). The only clinically significant laboratory abnormalities that occurred more frequently in the REMICADE group compared with the placebo group were elevated liver enzyme tests. Serious AEs occurred at rates of 2 percent in the placebo group, 3 percent in the 5 mg/kg group and 1 percent in the 3 mg/kg group. AEs observed were generally consistent with those described in the prescribing information, including information regarding serious infections. Please see "Important Safety Information" below.

About SPIRIT

SPIRIT was a Phase 2, multi-center, double-blind, placebo-controlled study evaluating the use of REMICADE induction therapy in 249 people with severe plaque psoriasis who had previously received psoralen plus ultraviolet light A (PUVA) or systemic therapy for psoriasis. Trial participants were randomized to receive REMICADE 3 mg/kg, REMICADE 5 mg/kg or placebo at weeks 0, 2, and 6 and were assessed biweekly for 10 weeks. At week 26, patients whose Physician Global Assessment (PGA) score indicated moderate to severe disease (n=114) were eligible for one additional infusion of their assigned treatment to assess the safety of retreatment after a 20-week treatment-free period.

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 6 percent of REMICADE-treated patients reported serious AEs
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SOURCE Centocor, Inc. Copyright©2008 PR Newswire. All rights reserved

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