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| |  Infliximab Safe, Effective In Children With Persistent, Severe Crohn's Disease MILWAUKEE, WI -- November 1, 2000 -- Children with active, severe Crohn's disease who had not responded to conventional therapy over four months and had not been able to taper off their potentially growth-stunting steroid therapy, showed significant improvement and were able to decrease steroid usage within four weeks of an infusion of a new biologic therapy, infliximab. The study, by Medical College of Wisconsin researchers, reported in the November issue of the American Journal of Gastroenterology, showed those children with early disease -- up to two years from time of diagnosis -- had a markedly prolonged response to the drug compared with those who were diagnosed with Crohn's disease for longer than two years. No serious, clinically significant adverse effects were shown during the 12-month study of 15 pediatric patients at Children's Hospital of Wisconsin. "Because Crohn's disease most frequently is diagnosed in adolescents and young adults, optimizing treatment in pediatric patients is crucial. We use corticosteroids to control inflammation, but when given on a long-term basis they can have serious side effects that are detrimental to physical and emotional development in adolescents," says the study's lead investigator, Subra Kugathasan, M.D., assistant professor of pediatrics at the Medical College. "Early use of infliximab in steroid-dependent children may enable pediatricians to titrate patients off steroids more quickly and may represent an optimal approach that is fast, effective and, especially important in pediatric cases, less prone to significant adverse effects." Crohn's disease is a chronic, debilitating and relapsing disorder characterized by inflammatory destruction of the gastrointestinal tract, most commonly affecting the large and small bowel. About 400,000 Americans suffer from Crohn's disease, with symptoms including diarrhea, fever, abdominal pain and weight loss. Up to 30 percent of patients develop fistulas, tunnel-like openings that burrow through the bowel wall into nearby organs or through the skin's surface. An estimated one in 800 U.S. children has Crohn's disease, usually presenting between 12 and 16 years of age. Patients with severe Crohn's disease often receive steroids to control inflammation. In addition to the stunted growth and delayed puberty specific to pediatric patients, steroids also may cause bone damage including osteoporosis, as well as neurologic difficulties, severe acne and moon face. Physicians typically limit steroid use and try to taper patients off steroids while using immunomodulators, which control inflammation but may take several months to become effective. However, many patients, including those in this study, are unable to taper off steroids, even when receiving immunomodulator therapy. Fifteen pediatric patients with severe and persistent refractory Crohn's disease, as defined by their inability to discontinue steroids, lack of response to immunomodulators, and active disease, were treated with one infusion of infliximab and followed over the next 12 months. All patients remained on immunomodulators during and after the infusion treatment period while investigators sought to determine infliximab's short-term efficacy, safety and duration of response. "Nearly half of these children were so severely disabled by Crohn's disease that they could not attend school or were actually hospitalized," says Dr. Kugathasan. "Within four weeks of the infliximab infusion, 94 percent had achieved significant decreases in their disease activity, and by week ten, 67 percent were in complete remission. One patient who was diagnosed with severe inflammation of the entire gastrointestinal tract showed dramatic intestinal healing five weeks after the infusion, as determined by endoscopy. This study indicates that early use of infliximab may represent an optimal approach to avoiding irreversible tissue damage when children are treated early in the disease process." Other investigators in this study were: Steven Werlin, M.D., professor of pediatric gastroenterology and David Binion, M.D., assistant professor of gastroenterology and hepatology at the Medical College; Janice Heikenen, M.D., assistant professor of pediatrics, Marshfield Clinic, Marshfield, Wi.; and pediatric gastroenterologists Alfonso Martinez, M.D. and Maria Rivera-Bennett, M.D. Infliximab marketed as Remicade®, belongs to the monoclonal antibody class of drugs. It blocks a key biologic response mediator called tumor necrosis factor alpha (TNF-Alpha) and is the only medication in its class indicated for the treatment of Crohn's disease in adults. Infliximab is believed to rapidly reduce inflammation in Crohn's disease patients by binding to and neutralizing TNF-Alpha on cell membranes as well as in blood and tissues. Related Link: Infliximab (Remicade®).
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