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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

onger for STELARA patients (14.4 and 18.1 weeks for 45 and 90mg, respectively) than for etanercept patients (7.3 weeks).  Response was regained in 84 percent of patients following retreatment with two STELARA (45 mg or 90 mg) injections.

Through week 12 of the study, the percentages of study participants experiencing at least one adverse event (AE) were comparable between the STELARA 45 mg group (66 percent), the STELARA 90 mg group (69 percent) and the etanercept 50 mg group (70 percent).  Those patients experiencing at least one serious AE through week 12 were reported as follows: 1.9 percent and 1.2 percent of patients receiving STELARA 45 mg or 90 mg, respectively, compared with 1.2 percent of patients receiving etanercept.  Rates of specific AEs were generally comparable between treatment groups with the exception of injection site reactions, which were reported in 25 percent of patients treated with etanercept versus 4.3 percent and 3.7 percent with STELARA 45 mg and 90 mg, respectively, though this disparity may have been influenced by the greater number of etanercept injections administered (at least 24 in the 12-week portion of the study) compared with two STELARA injections.  

Through week 64, AEs were generally comparable between patients in the 45 mg (87 percent) and 90 mg (89 percent) STELARA groups.  In patients who crossed over from etanercept to STELARA, generally similar proportions experienced AEs (79 percent versus 65 percent) and serious AEs (3.5 percent versus 3.4 percent) before versus after transitioning to STELARA.

About the ACCEPT Trial

The Phase 3, Multicenter, Randomized Study Evaluating the Efficacy and Safety of Ustekinumab Compared to Etanercept in the Treatment of Subjects with Moderate to Severe Plaque Psoriasis (ACCEPT) included 903 patients with chronic plaque psoriasis (etanercept=347, STELARA 45 mg=209, STELARA 90 mg=347).  Patients w
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SOURCE Centocor Ortho Biotech Inc.
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