Infliximab (Remicade) has now been approved by the Food and Drug Administration (FDA) to treat moderately to severely active ulcerative colitis in children six years of age and older who haven't achieved a successful therapeutic response with other drug therapy. Infliximab is a tumor necrosis factor (TNF) [alpha] blocker that suppresses the immune response. In an open-label, phase 3 study of 60 children with refractory ulcerative colitis, 73% had a clinical response and 40% were in clinical remission at eight weeks.

Infliximab was approved in 1998 and is used in the treatment of various inflammatory diseases, including Crohn's disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, and plaque psoriasis. Of these labeled indications, most were solely for adult use, the exception being Crohn's disease.

TNF plays a role in the inflammatory response by increasing the number of proinflammatory cytokines (like some interleukins), enhancing leukocyte migration, and activating neutrophil and eosinophil activity. In inflammatory disorders such as ulcerative colitis, levels of TNF are elevated and the immune system is hyperactive. Infliximab blocks the action of TNF, thereby decreasing the immune response. Because of its immunosuppressive action, infliximab has always been known to increase the risk of infections and its label has carried a warning that the drug can cause serious or life-threatening infections such as tuberculosis; bacterial sepsis; invasive fungal infections; infections with Legionella and Listeria bacteria; and bacterial, viral, or other infections with opportunistic organisms. Infliximab is also known to increase the risk of lymphoma and other malignancies in children and adolescents. Therefore, the use of infliximab for severe ulcerative colitis in children must be considered carefully.

Prescriptions are accompanied by a medication guide designed to help inform patients or their parents of the potentially serious adverse effects of the drug. Because infusion reactions are common, the nurse should closely monitor patients receiving infliximab. Patient and family education should also emphasize the importance of good handwashing, basic food safety principles, avoidance of those with illnesses, and other basic infection-prevention principles (upper respiratory infections are a common adverse effect, although they're not typically a serious problem). Because live vaccines shouldn't be administered during infliximab treatment, nurses caring for pediatric patients prescribed the drug should confirm that their immunizations are up to date before the start of drug therapy. To read the FDA news release regarding the new indication, go to http://1.usa.gov/ohcmi9.