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| |  ACG: Infliximab Reduces Reliance On Surgery And Hospital Services For Crohn's Disease NEW YORK, NY -- October 20, 2000 -- Patients with Crohn's disease, a serious gastrointestinal disorder, who are treated with infliximab (also known as Remicade), can greatly reduce their need for many medical services and interventions, including surgery and endoscopies. Data were presented at the American College of Gastroenterology annual meeting this week. "This is the first time that a medical therapy for Crohn's disease has been associated with a marked reduction in the use of expensive medical procedures like surgery," said Russell D. Cohen, M.D., assistant professor of clinical medicine and co-director, clinical inflammatory bowel disease, University of Chicago Medical Center. Dr. Cohen and his colleagues reviewed electronic medical records and charts and assessed the use of inpatient and outpatient medical services at the hospital for all patients (n=79) with Crohn's disease who received infliximab and had been treated at the University of Chicago Medical Center from three years prior and one year following their initial infusion. The study demonstrated that treatment with infliximab led to: -- A 38 percent decrease in the overall annual incidence of all surgeries (with an 18 percent decrease in GI surgeries, specifically) A troublesome complication of Crohn's disease in some patients is the development of fistulas, deep, ulcer-like tracts that burrow through the bowel wall into nearby organs or through the surface of the skin. When looking specifically at the subset of fistula patients (n=37), treatment with infliximab showed similar benefits: -- A 59 percent decrease in hospitalizations According to Dr. Cohen, previous studies have suggested that surgery accounts for half of overall medical costs associated with treatment of Crohn's disease while hospitalizations account for a third. "Given the high costs associated with surgery and hospitalization, the use of infliximab may translate to an overall savings for these patients and the healthcare system," commented Dr. Cohen. Affecting about 400,000 people in the United States, Crohn's disease is a debilitating disorder characterized by inflammation of the gastrointestinal tract. The inflammation involves the mucosal lining of the gut and can spread across the entire wall of the large and small bowel. Symptoms include diarrhea, fever, abdominal pain and weight loss. The disease, which has a serious impact on an individual's quality of life, can recur at various times over a lifetime, and there is no way to predict when a remission may occur or when symptoms may return. Infliximab was approved by the U.S. Food and Drug Administration on August 24, 1998, for the short-term treatment of moderately to severely active Crohn's disease among patients who have an inadequate response to conventional therapy. Infliximab was also approved for the treatment of fistula(s). Infliximab is the first of a new class of agents that block activity of a key inflammatory mediator called tumor necrosis factor alpha (TNF-a). Overproduction of TNF-a leads to inflammation in conditions such as Crohn's, rheumatoid arthritis and other autoimmune diseases. It is believed that infliximab reduces inflammation in patients with Crohn's disease by binding to and neutralizing TNF-a on the cell membrane and in the blood. Approximately five percent of Crohn's disease patients studied in clinical trials discontinued infliximab treatment. The most common reasons for discontinuation were infusion reactions and infections. TNF-a mediates inflammation and cellular immune response, including response to infection. Serious infections, including sepsis and fatal infections, have been reported in patients receiving TNF-blocking agents. Many of the serious infections in patients treated with infliximab have occurred in patients on concomitant immunosuppressive therapy that, in addition to their Crohn's disease or rheumatoid arthritis, could predispose them to infections. Patients treated with infliximab may have an increased risk of infection. Caution should be exercised when considering the use of infliximab in patients with chronic infection or a history of recurrent infection. Infliximab should not be given to patients with a clinically important, active infection. Patients who develop a new infection while undergoing treatment with infliximab should be monitored closely. If a patient develops a serious infection or sepsis, infliximab therapy should be discontinued. Related Link: infliximab (Remicade).
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