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| |  ACG: Case Report Suggests Infliximab May Be Useful in Ulcerative Colitis By Larry Schuster Special to DG News SEATTLE, WA -- October 23, 2002 -- A case study suggests that Centocor’s infliximab, approved for Crohn’s disease, may be effective in some cases of steroid-refractory ulcerative colitis. In a poster presentation here October 21 at the Annual Scientific Meeting of the American College of Gastroenterology (ACG), Dr. Mitchell Mah’moud, reported on a successful use of infliximab (Remicade) in a 31-year-old Caucasian female. The patient had a four-year history of ulcerative colitis, including the use of mesalamine, 6-mercaptopurine and prednisone. The patient was hospitalised for an exacerbation of her ulcerative colitis during a period in which she was tapering off her use of prednisone. She had an acute episode of bloody diarrhoea with abdominal pain and nausea, attributed to acute exacerbation of the disease. And she repeatedly experienced episodes of rectal bleeding and associated mucus in stool while on previous medications. Dr. Mah’moud, of the department of internal medicine, Boice-Willis Clinic, in Rocky Mount, North Carolina, United States, was referred to her when she was hospitalised after she had seen two other gastroenterologists, during her four-year history. One of the previous physicians had recommended she have her colon removed. He treated her with 5 mg/kg of infliximab every eight weeks for three or four treatments. She did so well, she had no more sick days from work, and for the first time in years she decided she could have a child, and he discontinued her infliximab treatments. She was put back on 6-mercaptopurine while she was trying to get pregnant. Six months after the discontinuation of infliximab, he said, she was still doing well. "She’s never been in remission for this period of time," he said. When he was preparing his report, he said he had found only one or two other cases in the literature of infliximab for steroid-refractory ulcerative colitis, and no other case describing a similar maintenance level use of infliximab. Dr. Mah’moud case report comes just after another team reported in the October issue of the American Journal of Gastroenterology on the use of infliximab for patients with moderate to severe ulcerative colitis. In that study, released before the ACG meeting, Dr. Gary Lichtenstein, director of the Center for Inflammatory Bowel Disease, University of Pennsylvania, reported on single or multiple doses of infliximab on 27 patients with active ulcerative colitis. The researchers found the drug appeared to induce clinical remission in many patients with moderate to severe ulcerative colitis. Twenty-four patients in the study were defined as severe, two as moderate and one as mild. After treatment, 12 patients were in remission, an additional six patients had a partial response and nine had no response. Three patients in that study reported adverse events, one had fatigue and two who did not respond to therapy had total colectomies. At ACG, Frank Closurdo, director of communications for Centocor, said recruiting has begun for a 600-patient trial of infliximab for ulcerative colitis for the United States and Europe. Dr. William J. Sanborn, head of Inflammatory Bowel Disease Research, Mayo Clinic, Rochester, MN, will lead the study.
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