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| |  DDW: Remicade (Infliximab) May Enable Patients With Crohn's To Discontinue Steroids SAN DIEGO, CA -- May 25, 2000 -- Patients treated with Remicade® (infliximab) for Crohn's disease, a serious gastrointestinal disorder, showed clinical benefits, including closing of fistulas and reduction of inflammatory signs and symptoms. Additionally, studies presented this week at the Digestive Disease Week (DDW) meeting reported that most patients were able to successfully withdraw from steroid use following treatment with Remicade. The studies, conducted at leading American and European institutions, also supported the safety of treatment with Remicade. According to study results presented at DDW: -- A study reported that steroid withdrawal was observed in more than 70 percent of Crohn's disease patients who were treated with Remicade -- The Mayo Clinic in Rochester, Minn. -- Clinical response of Remicade was associated with significant increases in disease-specific quality of life in refractory Crohn's disease, as well as fistulizing disease -- Centre Hospitalier, Luxemburg. -- In another study evaluating the steroid-sparing effect of Remicade, 40 percent of patients treated with Remicade were able to discontinue steroid therapy -- Beth Israel Deaconess Medical Center, Boston, Mass. "The fact that these studies reported both remission of Crohn's disease in many patients and successful withdrawal from steroid use provides hope to the hundreds of thousands of Crohn's patients," said Charles Sninsky, M.D., professor of medicine of the division of gastroenterology, director of the gastrointestinal (GI) clinic at Vanderbilt University and noted researcher studying the use of steroids in inflammatory bowel disease (IBD). "For too long, patients have not had an effective treatment alternative to steroids such as Remicade," he added. "What we're seeing in these studies, conducted at leading institutions around the world, are the same convincing clinical benefits and safety profile that were shown in our own clinical trials," said Thomas Schaible, Ph.D., senior director, medical affairs, at Centocor. "We are very pleased," he added, "and are committed to continuing research in this area." -- The Mayo Clinic in Rochester, Minn., conducted a study of 100 patients with refractory and/or fistulizing Crohn's disease. It was reported that 73 percent of patients receiving Remicade were able to discontinue steroid use. In addition, 53 percent of Remicade-treated patients showed remission of inflammatory symptoms; 35 percent showed closed fistulas; 69 percent showed improvement in both inflammation and fistulizing disease. Twenty-three percent were continued on intermittent Remicade as maintenance. Patients in the study received from one to seven infusions of Remicade for a total of 242 infusions administered. Median time to response was seven days, and median duration of response was 10 weeks. -- The Center Hospitalier in Luxemburg conducted a multicenter expanded access study in which 146 patients were evaluated by both CDAI (Crohn's Disease Activity Index) and IBDQ (Inflammatory Bowel Disease Questionnaire) scores. Tests were administered upon entry in the study and eight weeks after the last infusion in 89 patients (59 with refractory disease and 33 with fistulizing disease). The results showed that the clinical response to Remicade was associated with a significant increase in disease-specific quality of life in refractory Crohn's disease as well as in fistulizing disease. -- The Beth Israel Deaconess Medical Center in Boston, Mass., studied 100 patients who received a total of 207 Remicade infusions. Baseline, serial disease and perianal fistula activity were assessed prospectively every two weeks for six months using the Harvey Bradshaw Index and the Perianal Disease Activity Index. Steroid-sparing efficacy was assessed by ability to discontinue steroids following Remicade therapy. According to the study, 40 percent of patients who received Remicade as a steroid-sparing agent were able to discontinue steroid therapy. 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. In up to 30 percent of patients, Crohn's disease causes fistulas-openings that burrow through the bowel wall into nearby organs or through the surface of the skin. 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. Remicade was approved by the U.S. Food and Drug Administration (FDA) 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. Remicade was also approved for the treatment of fistula(s). Remicade is the first of a revolutionary new class of agents that block activity of a key inflammatory mediator called tumor necrosis factor alpha (TNF-alpha). Overproduction of TNF-alpha leads to inflammation in conditions such as Crohn's, rheumatoid arthritis and other autoimmune diseases. It is believed that Remicade reduces inflammation in patients with Crohn's disease by binding to and neutralizing TNF-alpha on the cell membrane and in the blood. Approximately five percent of Crohn's disease patients studied in clinical trials discontinued Remicade treatment. The most common reasons for discontinuation were infusion reactions and infections. TNF-alpha 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 Remicade 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 Remicade may have an increased risk of infection. Caution should be exercised when considering the use of Remicade in patients with chronic infection or a history of recurrent infection. Remicade should not be given to patients with a clinically important, active infection. Patients who develop a new infection while undergoing treatment with Remicade should be monitored closely. If a patient develops a serious infection or sepsis, Remicade therapy should be discontinued. Centocor markets Remicade in the United States. Schering-Plough Corporation has rights to market Remicade in all other countries throughout the world, except in Japan and parts of the Far East, where Remicade will be marketed by Tanabe Seiyaku, Ltd. Schering-Plough Corporation is a research-based company engaged in the discovery, development, manufacturing and marketing of pharmaceutical products worldwide. Related Links: Remicade (infliximab), Centocor and Schering-Plough Corporation.
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