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REMICADE Phase 3 data show rapid, significant, long-term psoriasis improvement

, data was analyzed from the REMICADE 5 mg/kg every eight week maintenance arm of each trial, the only regimen common to both EXPRESS and EXPRESS II. At week 10, after infusions at weeks 0, 2, and 6, the proportions of patients achieving PASI 75 were 80 percent versus three percent of placebo patients for EXPRESS and 75 percent versus two percent of placebo patients for EXPRESS II, (both P < 0.001 versus placebo). At week 10, the proportions of patients achieving PASI 90, or nearly complete skin clearance, were 57 percent versus one percent of placebo patients for EXPRESS and 45 percent versus 0.5 percent of placebo patients for EXPRESS II, (both P < 0.001 versus placebo). PASI 75 responses achieved at week 10 were maintained through week 26 in both EXPRESS and EXPRESS II (81 percent and 78 percent of patients achieved at least PASI 75 improvement from baseline, respectively), and the majority of patients achieved PASI 75 at week 50 in the REMICADE 5 mg/kg every eight-week maintenance groups.

"These data show great potential for REMICADE in the treatment of a disease that often carries great physical and emotional challenges," said Robert Matheson, MD, Oregon Medical Research Center, and study investigator. "The potential of achieving nearly complete skin clearance is exciting and holds great promise for patients with this difficult to treat disease."

Investigators reported that at week 10 patients in both EXPRESS and EXPRESS II receiving REMICADE experienced improvements in the Dermatology Life Quality Index (DLQI) and Physician's Global Assessment (PGA), measures of quality of life and psoriasis severity, respectively. In both studies, following 5 mg/kg induction therapy, REMICADE-treated patients experienced a median improvement of nine points in DLQI, a change that is considered to be a clinically meaningful decrease in psoriasis-related burden for the patient, compared to no improvement for placebo patients (REMICADE vs. placebo, -9.0 ve
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Contact: Michael Parks
215-983-8000
Centocor, Inc.
3-Mar-2006


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