Phase 3 Study of Remicade for Ulcerative Colitis in Pediatric Patients
Centocor Ortho Biotech announced results from its Phase 3 study of Remicade (infliximab) in the treatment of pediatric patients with moderately to severely active ulcerative colitis (UC). This randomized, multicenter, open-label study enrolled 60 patients who had previously failed to respond to or tolerate treatment with 6-mercaptopurine, azathioprine, corticosteroids, and/or 5-aminosalicylate. Patients were administered Remicade 5mg/kg at Weeks 0, 2, and 6. Remicade induced clinical response in 73.3% of patients aged 6–17 years at Week 8, the primary endpoint of the trial.
Patients achieving clinical response at Week 8 (n=45) were randomized to receive Remicade 5mg/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%) achieved remission by the Pediatric UC Activity Index compared with the group that received Remicade every 12 weeks (18.2%), though this did not reach statistical significance (P=0.146) due to the small sample sizes.
Remicade is an anti-tumor necrosis factor-alpha biologic agent with broad clinical utility with indications in Crohn's disease, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, ulcerative colitis, pediatric Crohn's disease and psoriasis.
For more information call (888) 779-9769 or visit www.remicade.com/hcp.