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(infliximab, Centocor, Johnson & Johnson)

A tumor necrosis factor-a (TNF-a) blocking agent for reducing signs and symptoms, achieving clinical remission and mucosal healing, and eliminating corticosteroid use in patients with moderately to severely active ulcerative colitis who have had an inadequate response to conventional therapy. The first biologic approved for ulcerative colitis and the first new therapy approved for ulcerative colitis since the 5-aminosalicylic agents in the 1990s. First approved for Crohn's disease in 1998; other approved indications include rheumatoid arthritis (1999), ankylosing spondylitis (2004), and psoriatic arthritis (May 2005).

* Recommended Dosage: Administered in an intravenous infusion at 0, 2, and 6 weeks (induction); and every 8 weeks thereafter (maintenance).

* Special Considerations: The risk of serious infections such as TB, sepsis, and pneumonia, is increased with Remicade, as with other TNF blockers. Lymphoma rates in treated patients have been greater than expected in the general population, but patients with diseases such as rheumatoid arthritis and ulcerative colitis may be at a greater risk of lymphoma, even without such treatment. The safety data in the two trials that led to this approval appear consistent with experience in rheumatoid arthritis and Crohn's, with one case each of histoplasmosis and TB, as well as a few serious infections and a case of optic neuritis, said William J. Sandborn, M.D., the lead investigator in one trial. Estimated annual cost is $15,000-$17,000, according to a centocor spokesperson.

* Comment: In the two studies of 728 patients with moderately to severely active ulcerative colitis who were not responding to other treatments, including steroids and immunosuppressives, the rates of clinical responses, sustained clinical responses, clinical remissions, and mucosal healing were significantly greater among those treated with Remicade at 30 weeks. Significantly more patients on Remicade were able to discontinue prednisone, compared with those on placebo. "Response, remission, and mucosal healing occurred early," and responses seen at 8 weeks were sustained out to 30 weeks, said Dr. Sandborn, director of the inflammatory bowel disease clinical research unit at Mayo Medical Center, Rochester, Minn.

While the mechanism behind the drug's clinical effect is not entirely clear, it is known that TNF concentrations in the intestinal wall, stool, and blood are elevated in patients with Crohn's disease and ulcerative colitis, he pointed out. Dr. Sandborn is currently doing Centocorfunded research, and is a consultant to the company. Despite the cost of Remicade, "surgery is also expensive and has its own set of complications and outcome problems," including an increased risk of infertility in younger women.

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Title Annotation:NEW & APPROVED
Author:Mechcatie, Elizabeth
Publication:Internal Medicine News
Geographic Code:1USA
Date:Oct 15, 2005
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