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FDA Approves Infliximab (Remicade®) as the First Biologic Treatment for Ulcerative Colitis The Food and Drug Administration (FDA) has approved infliximab (Remicade®) for the treatment of ulcerative colitis. Manufactured by Centocor, infliximab, which is already approved for the treatment of Crohn's disease, belongs to a relatively new class of drugs called biologics. While traditional pharmaceuticals are made of chemicals, the new biologic agents are developed out of proteins from living cells. Additionally, biologics differ from traditional immunosuppressive drugs in an important respect: Instead of suppressing the immune system as a whole, biologics target particular parts of the immune response in order to control inflammation.
In ulcerative colitis, infliximab is now indicated for:- reducing signs and symptoms;
- achieving clinical remission and healing of the mucous membranes that line the intestines; and
- eliminating the use of corticosteroids in patients with moderately-to-severely active colitis who have had an inadequate response to conventional therapy.
The drug blocks TNF-alpha (tumor necrosis factor alpha), which belongs to a class of proteins called cytokines. Secreted by specialized immune cells, TNF-alpha promotes inflammation in the intestines. Infliximab binds to TNF-alpha and neutralizes it, thus short-circuiting inflammation before it rages out of control.
Infliximab is currently the only biologic indicated for the treatment of both Crohn's and colitis, the major forms of inflammatory bowel disease (IBD). However, a number of other anti-TNF drugs have already been approved for the treatment of other diseases, with several in clinical trials for IBD. For more information about these agents and about clinical trials in your area, please visit www.ccfa.org/trials.
William J. Sandborn, M.D., professor of Medicine at the Mayo Clinic College of Medicine, commented favorably on the performance of infliximab in the clinical trials that preceded the FDA's final approval of the drug for colitis: "Not only did many patients in these trials experience a significant reduction in the occurrence of symptom flare-ups, some achieved clinical remission and mucosal healing as well. This is welcome news for these patients, whose only option otherwise may have been surgery to remove their colon."
It is important to keep in mind that treatment for ulcerative colitis must be tailored to the needs of the individual patient. The decision to use infliximab for this disease is complex and will be based on a number of factors, including a patient's response to other therapies. In addition, the drug's immediate benefits must be weighed against its long-term effects on the colon, which are not known. Therefore, CCFA urges patients with colitis to discuss the risks and benefits of infliximab therapy with their IBD physician before making the decision to try the new treatment.
Infliximab was first approved in the United States for the treatment of Crohn's disease in 1998 and is also indicated for the treatment of rheumatoid arthritis, ankylosing spondylitis, and psoriatic arthritis.
"We are optimistic that the use of a treatment like Remicade will provide many people with relief from the debilitating symptoms that have had such a profound impact on their lives," said Rodger DeRose, President and CEO of CCFA. "Results from a recent patient survey revealed that ulcerative colitis affects many aspects of people's lives, from their relationships with families and employers to the ability to participate in social activities."
To learn more about infliximab for the treatment of ulcerative colitis, please visit the following informational Web site, sponsored by Centocor: www.remicade.com.
Date Posted: September 16, 2005 |
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