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New Phase 3 Study Results Show REMICADE® is Effective in the Treatment of Pediatric Patients With Moderate to Severe Ulcerative Colitis
Date:5/9/2011

tely to severely active UC in pediatric patients who have had an inadequate response to conventional therapy. The REMICADE pediatric UC sBLA was designated priority review by the FDA. On November 12, 2003, the FDA designated REMICADE orphan drug status for the treatment of pediatric UC.

A total of 60 patients with moderately to severely active UC (Mayo score of 6-12, with an endoscopy subscore more than or equal to 2) were enrolled in the trial.  Patients had previously failed to respond to or tolerate treatment with 6-mercaptopurine (6-MP), azathioprine (AZA), corticosteroids, and/or 5-aminosalicylate (5-ASA) and were administered REMICADE 5 mg/kg at weeks 0, 2, and 6.  At week 8, REMICADE induced clinical response according to the Mayo score in 73.3 percent of patients, the primary endpoint of the trial.  The Mayo score is a 12-point clinical assessment and colonoscopy-based measure of disease activity.   Also at week 8, 40 percent of patients were in clinical remission by the Mayo score and 33.3 percent were in remission by the validated, non-invasive clinical assessment of disease activity in children, the Pediatric UC Activity Index (PUCAI).  In addition, 68.3 percent of patients achieved mucosal healing at week 8.

Patients achieving clinical response at week 8 (n=45) were randomized to receive REMICADE 5 mg/kg every eight weeks through week 46 (n=22) or every 12 weeks through week 42 (n=23).  At week 54, twice as many patients in the group that received REMICADE every eight weeks (38.1 percent) achieved remission by the PUCAI compared with the group that received REMICADE every 12 weeks (18.2 percent), though this did not reach statistical significance (P = 0.146) due to the small sample sizes.  More patients on corticosteroids at baseline were in remission and off corticosteroids at week 54 in the maintenance group that received REMICADE every eight weeks (38.5 percent) than in the every 12-week mainten
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SOURCE Centocor Ortho Biotech Inc.
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