Remicade is a genetically engineered monoclonal antibody. It reduces inflammation (swelling/redness) by blocking the action of tumor necrosis factor-alpha (TNF-alpha). Remicade was initially approved in 1998 to treat Crohn's disease in adults.
In an FDA news release, Steven Galson, MD, MPH, who directs the FDA's Center for Drug Evaluation and Research, noted that there have been no satisfactory treatments for children with Crohn's disease who have moderate to severe disease activity despite traditional or conventional therapies.
"Remicade is not a cure, but it provides a much-needed option for reducing the symptoms and inducing and maintaining disease remission in children who have no other safe and effective therapy," says Galson, in the FDA news release "We believe that the potential benefits of this product outweigh the risks that are known and have been carefully evaluated."
Drug Tested in Kids With Crohn's
The safety and effectiveness of Remicade in pediatric Crohn's disease were assessed in a randomized study in 112 children who were 6 to 17 years old. The children had moderately to severely active Crohn's disease and had had an inadequate response to conventional therapies.
The proportion of these patients who achieved clinical response compared favorably with the proportion of adults in an earlier Remicade study in adult Crohn's disease. The pediatric trial's results showed no new safety concerns not already expressed in the product's current label, according to the FDA.
In general, the safety profile for Remicade in the pediatric trial was similar to the data that was presented at an FDA Arthritis Advisory Committee meeting in March 2003. That data dealt with the extent to which anti-TNF therapies may increase the risk of serious infections and malignancies, such as sepsis and pneumoniapneumonia in certain patients.
These risks, which are described in a study in the May 17 issue of The Journal of the American Medical Association, are included in the current labels for all approved TNF-alpha blocking agents, including Remicade.
Warnings Section to Be Updated
More recently, the FDA has received rare postmarketing reports of an aggressive and often fatal type of T-cell lymphomalymphoma (hepatosplenic T-cell lymphoma) in adolescent and young adult patients with Crohn's disease.
In most, but not all cases, these patients were treated with standard immunosuppressive therapies (azathioprine or 6-mercaptopurine) in combination with Remicade. The FDA is working with the manufacturer to address this risk by updating the warnings sections of the Remicade label.
The FDA continues to actively and carefully monitor the safety experience with Remicade and similar therapies in an effort to maximize their "very real benefits yet limit, to the degree possible, the potential for very serious toxicities," states the FDA's news release.