Infliximab is approved for use in children over age 6 years who have moderately to severely active ulcerative colitis and an inadequate response to conventional therapy, the Food and Drug Administration announced on Sept. 23.
While the tumor necrosis factor (TNF) blocker offers another therapeutic option for these children, "there are serious risks associated with its use," said Dr. Donna Griebel, director of the Division of Gastroenterology and Inborn Errors Products in the FDA’s Center for Drug Evaluation and Research.
The FDA’s Gastrointestinal Drugs Advisory Committee unanimously voted on July 21 that the risk-benefit profile of infliximab (Remicade, Janssen Biotech Inc.) supported this indication. All but one panelist voted that safety concerns remained that still had not been adequately addressed, particularly with long-term treatment. The recommendation was based on the results of a multicenter, randomized, open-label study in 60 children aged 6-17 years with moderately to severely active ulcerative colitis that had failed to respond to or to tolerate conventional treatment.
Infliximab carries a boxed warning for risk of serious infections and cancer. Increased risks of infections include tuberculosis and infections caused by viruses, fungi, or bacteria. Cases of unusual cancers have been reported in adolescent and young adult patients using TNF-blocking agents, including cases of hepatosplenic T-cell lymphoma.
In its announcement of the approval, the FDA stated that children should have all of their vaccines brought up to date before starting treatment with infliximab and should not receive live vaccines while taking the drug. According to the FDA, the most common side effects of infliximab are worsening of ulcerative colitis, upper respiratory infections, infusion-related reactions, and headache.
Infliximab also is approved for the treatment of Crohn’s disease in adults and children older than 6 years, as well as for rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, and plaque psoriasis in adults.
According to the FDA, 50,000-100,000 children in the United States have inflammatory bowel disease and, of those, 40% have ulcerative colitis.