Biologics and Ulcerative Colitis (UC)

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    Biologic medications are a relatively new treatment for people with inflammatory bowel disease. These medications are made from proteins, but may also contain naturally occuring compunds. Biologics are antibodies that bind to specific parts (proteins) of the immune response specifically in the gut lining, and as a result, block the normal function of the inflammation cascade.  By slowing down inflammation, these medications can decrease disease activity. They do this by acting on specific targets involved in the immune response, including tumor necrosis factor (TNF)-alpha, interleukins, adhesion molecules, colony-stimulating factors, and others.

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    Due to the profound clinical response to biologic therapy in people with Crohn’s disease (CD), trials quickly were undertaken to see the effect of biologics in UC, where similar factors are known to play a role in disease activity - as in CD. Several large studies have shown biologics to extremely effective in treating UC and maintain remission in even severe disease.

     

    Which biologics to use?

     

    While the mechanism by which biologics treat UC and CDs is the same, the response to each medication may differ. The following are biologics that are currently used to effectively treat UC:

     

    • Infliximab and adalimumab, TNF-alpha inhibitors, are approved for treatment and maintenance of remission for moderate to severe UC refractory to conventional therapies (i.e. 5-aminosalicylates (5-ASA’s), steroids, immunomodulators (azathioprine or 6-mercaptopurine)). 
    • Vedolizumab, an integrin receptor antagonist, can be used to treat moderate to severe UC unresponsive to infliximab, immunomodulators, or in those who remain steroid-dependent.
    • Golimumab, a TNF-alpha inhibitor, is approved for those with moderate to severe UC who are steroid-dependent or failure to respond to 5-ASA’s or immunomodulators.

     

    How do you take biologics?

     

    Biologics are administered either as an infusion or injection. Infusions are usually given over 30, 60, or 120 minutes at an infusion center.  They are given at specific time intervals, typically every four or eight weeks after an initial induction period, depending on the medication. Injections are administered under the skin and can be done at home. Injections are given every two to four weeks, depending on the medication, again, after an initial induction period.

     

    When to use biologics

     

    Biologics are extremely effective medications in treating active UC (that is not controlled with other conventional therapies, including 5-ASA’s, corticosteroids, and immunomodulators). In patients with moderate to severe active colitis and in whom steroids cannot be stopped, then biologics are used to induce and/or maintain remission. Using biologics in UC can help prevent the need for colectomy.

     

    How to use biologics

     

    Before starting

     

    Before initiating therapy with any biologic agent, various tests need to be completed to ensure safety in administering the medication. Anyone with a history of tuberculosis (TB) or have been exposed to TB should undergo testing for the disease. If positive, treatment for TB should be started prior to starting biologics. Everyone should also be tested for hepatitis infection, and they should be vaccinated for Hepatitis A and B if they are not immunized. People with uncontrolled heart failure should not use biologics. Those with active infections, certain neurological disorders (multiple sclerosis or autoimmune neurological disorders), or untreated cancers (lymphoma, malignant melanoma, renal cell carcinoma, and lung cancer) should not be started on biologics. Also, patients who are already immunosuppressed for any underlying medical conditions should not use biologics.

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    How long should they be used

     

    Typically, once a biologic is started, it is continued indefinitely. When disease is well controlled on a regimen, then it is recommended that such a regimen be continued.  With the use of some medications, stopping the medication resulted in formation of antibodies to that biologic. A diminished response to the medication was found the second time it was needed. Stopping all therapy, despite being clinically in remission (endoscopically and by symptoms) is not advised.

     

    Are there any side effects

     

    Potential side effects of biologic agents include injection site reactions or infusion reactions, low white blood cell count, infections, certain neurological diseases, heart failure, skin reactions, skin cancers, other solid organ and blood cancers. While many of these side effects are potentially serious, they are uncommon. Also, the risks of a side effect must be weighed against the benefit of successfully treating UC and its potential complications. 

     

    In general, biologics are extremely safe and effective medications used to treat UC. It is very important that you work with your doctor when taking these medications and keep them informed of any symptoms you experience, either related to your UC or potential side effects of the medications.  Again, it is strongly advised that you never stop or alter your medication regimen on your own without the guidance of your physician. 

     

     

Published On: February 18, 2016