Biologics for Inflammatory Bowel Disease
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How It Works
These medicines stop a protein that increases inflammation in the body. They block the inflammatory response that happens in Crohn's disease and ulcerative colitis . They are given as a shot. Infliximab and natalizumab are given as a shot in a vein ( intravenous, or IV ). Adalimumab and certolizumab are given as a shot under the skin (subcutaneous).
Why It Is Used
These medicines are used to start remission (a period without symptoms) in people who have Crohn's disease or ulcerative colitis. They are also used to help someone stay in remission.
These medicines are usually used when the disease doesn't get better with other medicines. They may also be used in people who cannot take other medicines.
Infliximab may also be used to treat abnormal connections ( fistulas ) between the intestines and organs in moderate-to-severe Crohn's disease.
How Well It Works
In multiple studies, almost 70 out of 100 people taking infliximab had fewer symptoms or had healed fistulas. 1
Adalimumab has shown promise in treating Crohn's disease in multiple studies. 2 It works like infliximab and may be good for people who are allergic to infliximab.
Studies show that natalizumab works to stop the symptoms Crohn's disease in some people and to keep some people free of symptoms. But natalizumab may cause a serious and life-threatening disease called PML. Because of this risk, natalizumab is only available through a special prescription drug program. 5
In one study, between 60 and 70 out of 100 people with ulcerative colitis were better 8 weeks after getting infliximab treatment. In another study, twice as many people got better after receiving infliximab compared to those taking a placebo. 6
In one study, almost 20 out of 100 people with ulcerative colitis were better after 8 weeks of using adalimumab. 7 This drug hasn't been studied as much for ulcerative colitis compared to other medicines. Doctors still don't know a lot about how well it works.
All medicines have side effects. But many people don't feel the side effects, or they are able to deal with them. Ask your pharmacist about the side effects of each medicine you take. Side effects are also listed in the information that comes with your medicine.
Here are some important things to think about:
- Usually the benefits of the medicine are more important than any minor side effects.
- Side effects may go away after you take the medicine for a while.
- If side effects still bother you and you wonder if you should keep taking the medicine, call your doctor. He or she may be able to lower your dose or change your medicine. Do not suddenly quit taking your medicine unless your doctor tells you to.
Call 911 or other emergency services right away if you have:
- Trouble breathing.
- Swelling of your face, lips, tongue, or throat.
Call your doctor right away if you have:
- Signs of illness or infection, such as chills, cough, or fever.
- Chest pain or tightness.
- A rash on your head, face, or belly.
- Belly pain or fullness.
- Lower back or side pain, especially with painful urination.
Common side effects of this medicine include:
- Stomach pain, nausea, and vomiting.
- Painful throat.
- Redness, itching, or swelling at the injection site.
- Skin problems, such as bleeding, blistering, or crusting.
What To Think About
Warnings about serious side effects of biologics have been issued. The U.S. Food and Drug Administration (FDA) and the drug's manufacturers have warned about:
- An increased risk of a serious infection. Biologics affect the body's ability to fight all infections. So if you get a fever, cold, or the flu while you are taking this medicine, let your doctor know right away.
- An increased risk of blood or nervous system disorders. Call your doctor if you have symptoms of blood disorders (such as bruising or bleeding) or symptoms of nervous system problems (such as numbness, weakness, tingling, or vision problems).
- An increased risk of lymphoma (a type of blood cancer) in children and adolescents who take this medicine for longer than 2½ years (30 months). Adults, children, and adolescents who take this medicine also have a higher risk for leukemia and other cancers.
- An increased risk of liver injuries. Call your doctor if your skin starts to look yellow, if you are very tired, or if you have a fever or dark brown urine.
- An increased risk of psoriasis .
In very few cases, natalizumab has caused a serious and life-threatening brain infection called PML (progressive multifocal leukoencephalopathy). Natalizumab is tightly controlled because of this. If you take natalizumab, you will need to enroll in a program called the Crohn's Disease–Tysabri Outreach Unified Commitment to Health (CD-TOUCH) Prescribing Program.
Your risk for getting PML increases if you have any of these risk factors:
- You have been taking natalizumab for longer than 2 years.
- You have taken other immunosuppressant medicines, such as methotrexate or cyclophosphamide.
- You have ever been infected with the JC virus. There is a test your doctor can do to see if you have antibodies to the JC virus in your blood.
Medicine is one of the many tools your doctor has to treat a health problem. Taking medicine as your doctor suggests will improve your health and may prevent future problems. If you don't take your medicines properly, you may be putting your health (and perhaps your life) at risk.
There are many reasons why people have trouble taking their medicine. But in most cases, there is something you can do. For suggestions on how to work around common problems, see the topic Taking Medicines as Prescribed.
Advice for women
If you are pregnant, breast-feeding, or planning to get pregnant, do not use any medicines unless your doctor tells you to. Some medicines can harm your baby. This includes prescription and over-the-counter medicines, vitamins, herbs, and supplements. And make sure that all your doctors know that you are pregnant, breast-feeding, or planning to get pregnant.
Follow-up care is a key part of your treatment and safety. Be sure to make and go to all appointments, and call your doctor if you are having problems. It's also a good idea to know your test results and keep a list of the medicines you take.
- Friedman S, Lichtenstein GR (2006). Crohn's disease. In MM Wolfe et al., eds., Therapy of Digestive Disorders, 2nd ed., pp. 785–801. Philadelphia: Saunders Elsevier.
- American Gastroenterological Association (2007). American Gastroenterological Association consensus development conference on the use of biologics in the treatment of inflammatory bowel disease. Gastroenterology, 133(1): 312–339.
- Schreiber S, et al. (2007). Maintenance therapy with certolizumab pegol for Crohn's disease. New England Journal of Medicine, 357(3): 239–250.
- Sandborn WJ, et al. (2007). Certolizumab pegol for the treatment of Crohn's disease. New England Journal of Medicine, 357(3): 228–238.
- MacDonald JK, McDonald JWD (2007). Natalizumab for induction of remission in Crohn's disease. Cochrane Database of Systematic Reviews (1).
- Rutgeerts P, et al. (2005). Infliximab for induction and maintenance therapy for ulcerative colitis. New England Journal of Medicine, 353(23): 2462–2476.
- Reinisch W, et al. (2011). Adalimumab for induction of clinical remission in moderately to severely active ulcerative colitis: Results of a randomised controlled trial. Gut, 60(6): 780–787.
Last Revised: November 5, 2012
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