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STELARA(TM) Shows Greater Efficacy Than Etanercept for Treatment of Moderate to Severe Plaque Psoriasis: Phase 3 Comparator Study Published in The New England Journal of Medicine
Date:1/14/2010

Area and Severity Index (PASI 75) at week 12, the primary endpoint, compared with 57 percent of patients receiving subcutaneous injections of 50 mg etanercept twice per week for 12 weeks (P = 0.01 for STELARA 45 mg; P < 0.001 for STELARA 90 mg, each compared with etanercept).  Onset of clinical response appeared more rapidly among STELARA-treated patients, with higher numbers of patients achieving PASI 75 by week 8 compared with patients receiving etanercept.  

Investigators also reported that a greater proportion of patients receiving STELARA achieved a marked improvement in psoriasis as assessed by PASI 90 response, or nearly complete clearance of psoriasis.  At week 12, 36 percent of patients receiving STELARA 45 mg and 45 percent of patients receiving STELARA 90 mg achieved PASI 90 compared with 23 percent of patients receiving etanercept (P < 0.001 for each comparison versus etanercept).  Moreover, a greater proportion of patients in both the STELARA 45 mg and 90 mg treatment groups achieved a Physician Global Assessment (PGA) score of "cleared" or "minimal" (65 percent and 71 percent, respectively) compared with patients in the etanercept treatment group (49 percent) (P < 0.001 for each comparison versus etanercept).

Patients who had an inadequate response to etanercept, as measured by PGA score (classified as moderate, marked or severe psoriasis at week 12), received one injection of STELARA 90 mg at weeks 16 and 20.  At week 28, investigators reported that 49 and 23 percent of patients who failed to respond to etanercept and who crossed over to STELARA achieved PASI 75 and PASI 90, respectively.

In addition, patients classified as responders (having a PGA score of cleared, minimal or mild) at week 12 discontinued therapy until recurrence of psoriasis (PGA of moderate or greater).  In these patients, the median length of time to disease recurrence was l
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SOURCE Centocor Ortho Biotech Inc.
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