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| |  Repeat Use of Remicade Elicits Crohn’s Disease Symptom Remission MALVERN, PA. -- September 30, 1999 -- Patients with Crohn’s disease who were treated with Remicade™ (infliximab) at regular intervals experienced remission of their debilitating bowel symptoms with no increase in adverse events throughout the course of their treatment and beyond. Results from an international Phase II clinical trial, reported in the October issue of Gastroenterology, support the continued use of Remicade in patients who do not adequately respond to conventional therapies. "This study is of tremendous significance because of the great need for rapid control and ongoing remission of Crohn’s disease," said Paul Rutgeerts, M.D., Ph.D., University Hospital Gasthuisberg, Leuven, Belgium, lead author of the study. "These findings provide hope for millions of patients with Crohn’s disease who are frustrated by the limited efficacy of conventional therapies." The randomized, double-blind, placebo-controlled, parallel-group trial studied 73 patients in North America and Europe with active Crohn’s disease who had not adequately responded to conventional therapies. Participants had demonstrated a clinical response to a single dose of Remicade or placebo in an initial study 12 weeks earlier. They were then randomly assigned to receive four infusions of Remicade (10 mg/kg) or placebo at eight-week intervals. Patients retreated with Remicade maintained the benefit of the initial treatment, whereas patients in the placebo group had a gradual loss of clinical benefit. At 36 weeks, 72 percent of Remicade patients experienced clinical response, compared with 44 percent of placebo patients. At 44 weeks - eight weeks following the last infusion - the trend continued with 62 percent of Remicade-treated patients maintaining the response, compared with 37 percent of placebo patients. Clinical remission was attained by a greater proportion of patients retreated with Remicade than patients retreated with placebo. The percentage of Remicade patients achieving remission during retreatment reached 60 percent versus 35 percent of placebo patients. At week 44 - eight weeks after the last infusion - 53 percent of Remicade patients were still in remission compared with 20 percent of placebo patients. Remicade treatment was well tolerated. There was no difference between the treatment and placebo groups in the overall incidence of adverse events. The most common adverse events were upper respiratory tract infection, headache, abdominal pain and nausea. The incidences of upper respiratory tract infection, nausea bronchitis and pharyngitis were modestly higher in the Remicade retreatment group compared to placebo. Remicade, which is marketed in the United States by Centocor, Inc., was approved by the 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 blocks 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 disease, rheumatoid arthritis and other chronic inflammatory conditions. 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.
Related Link: Centocor, Inc.
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