Centocor Ortho Biotech reported positive data from a Phase III Remicade (infliximab) trial evaluating the anti-TNF-alpha drug in the treatment of pediatric patients with moderately to severely active ulcerative colitis. A BLA for use of Remicade in this indication was submitted to FDA in December 2010.
The open-label Phase III study evaluated the efficacy of a three-dose Remicade infusion regimen in terms of safety and clinical response in 60 patients aged 6–17 years who had previously failed to respond to or tolerate treatment with 6-mercaptopurine, azathioprine, corticosteroids, and/or 5-aminosalicylate. Participants received three doses of Remicade over six weeks. At week eight, 73.3% of treated patients achieved clinical response, measured by the Mayo score, and 40% of patients were in clinical remission. 68.3% of patients achieved mucosal healing at week eight.
Forty-five patients achieving a clinical response at week eight were then randomized to continue receiving Remicade every eight weeks for 46 weeks, or every 12 weeks for 42 weeks. At week 54, 38.1% of patients in the cohort receiving Remicade every eight weeks achieved remission according to the pediatric UC Activity Index, compared with 18.2% of those who received the drug every 12 weeks. These results did not represent statistical significance due to the small sample sizes, however.
Remicade received FDA clearance for treating adults with moderately to severely active ulcerative colitis in 2005, and the following year was approved for maintaining clinical remission and mucosal healing in adult patients. The drug is now approved in various markets for a range of conditions including rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, Crohn disease, ulcerative colitis, and psoriasis. Centocor claims the drug was the first anti-TNF treatment to be approved for separate indications in gastroenterology, rheumatology, and dermatology.