Centocor Ortho Biotech has reported positive results from a Phase III study of Remicade (infliximab) as a treatment of moderate-to-severe active ulcerative colitis in paediatric patients.
The study included 60 patients with active ulcerative colitis, a chronic inflammatory bowel disease of the colon. It showed that the drug induced clinical response in 73% of patients aged six to 17 years old, and also provided safety during induction and maintenance treatment.
The drug is known to cause side effects including a reduced ability to combat infections, lymphoma, psoriasis, and blood and nervous system disorders.
Remicade, the first anti-tumour necrosis factor (TNF)-alpha treatment, has already received US Food and Drug Administration approval for the treatment of ulcerative colitis in adults.
It is also approved for maintaining clinical remission and mucosal healing indications in adults with the condition.