What is IBD?

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Medical Therapies in Pediatric IBD

Even though scientists have not yet found a cure for IBD, there are many medicines used to treat these conditions. They are helpful in eliminating symptoms, promoting normal growth and sexual development, and controlling complications. It is important for patients and their families to understand that when carefully monitored by their physicians, IBD patients can achieve normal daily functioning with minimal complications.

The following medicines are used in the treatment of IBD:

Corticosteroids

These agents can be taken orally, intravenously, or rectally to acutely suppress gastrointestinal inflammation (this is known as inducing a remission of active disease). They include prednisone, methylprednisolone, and hydrocortisone. Oral corticosteroids are used in children with moderate symptoms; intravenous medicines are for those with more severe problems. Rectal suppositories, enemas, or foam-based preparations are of primary help in patients with active disease in the anus, rectum and/or left colon. Doctors carefully monitor the usage of corticosteriods because of the possible side effects associated with long-term use. Cosmetic changes such as puffy cheeks, acne, or excessive hair growth are usually temporary, and they disappear when the course of treatment is over. Other potentially more troublesome side effects, such as growth impairment, demineralized bones or eye problems, can occur with long term use. Because of these side effects, and the fact that these agents do not usually maintain long term remission, most physicians attempt to use corticosteroids for relatively short periods of time. Newer corticosteroids have been developed to act locally in the intestine with fewer body-wide side effects than the older types of corticosteroids. One such medication, budesonide (Entocort EC®), is commercially available as an oral formulation designed to treat inflammation in the end of the small intestine and colon. It can effectively induce remission of active disease in many children but like other forms of corticosteroids, it has only a limited role for the long term maintenance therapy.

Sulfasalazine (Azulfidine®)

This drug combines a sulfa antibiotic (sulfapyridine) with a locally acting anti-inflammatory agent (5-ASA). It is extremely effective in mild to moderate attacks of colitis and often induces prolonged remission in children. Most patients tolerate this drug extremely well, and often take it safely for many years. There are, however, some complications that can be associated with sulfasalazine. These include allergic reactions (usually a rash, often due to the sulfa portion of the medication), headaches, and mild indigestion if the drug is taken on an empty stomach. Occasional patients experience worsening of diarrhea and bleeding due to sulfasalazine. Although sulfasalazine interferes with absorption of folic acid, deficiency can be prevented by routine folic acid supplementation. Sulfasalazine may also cause occasional male infertility in young adults which reverts back to normal within three months of discontinuing the drug.

Mesalamine (Asacol®, Pentasa®, Rowasa®, Canasa®), Olsalazine (Dipentum®) and Balsalazide (Colazal®)

These agents are all locally acting anti-inflammatories which utilize different mechanisms for delivery of the same active ingredient to the inflamed intestine. All are 5-ASA medications and therefore similar in efficacy to sulfasalazine, but may have fewer side effects than sulfasalazine because they do not contain sulfa. These medications are most useful in controlling mild to moderate colitis (both ulcerative and Crohn's colitis), and in maintaining remission of symptoms once other treatments have controlled more severe disease activity. A number of these drugs have also been shown to decrease the frequency of Crohn's disease recurrence following surgery. Studies are underway to determine whether high doses of any of these agents might be useful in the treatment of active Crohn's disease in patients who have not needed surgery.

Metronidazole (Flagyl®)

This antibiotic exerts anti-inflammatory effects separate from its effects on intestinal bacteria. It is primarily used in patients with Crohn's colitis or to treat the perianal complications of Crohn's disease. There are a number of side effects associated with this drug. Some patients develop a metallic taste in the mouth.

Adolescents may also experience abdominal distress, nausea, vomiting, flushing or headache if they drink alcohol while being treated with metronidazole. Occasionally, they develop a peculiar, but reversible, sense of tingling or numbness in the hands and feet after taking the drug for a number of months.

Ciprofloxacin (Cipro®)

Another oral antibiotic which can have effects similar to that described above for metronidazole. Because of potential toxicity to growing bones, this medication must be used with caution in children and adolescents who have not completed their height growth.

Rifaximin (Xifaxin®)

This oral antibiotic suppresses the growth of many of the bacteria that normally reside within the intestine. It works locally within the intestine, so it has minimal effect on the rest of the body. Because the inflammation seen in IBD is promoted by the gut immune system's exposure to bacteria, suppressing the total number of bacteria can help decrease the activity of bowel inflammation.

Azathioprine (Imuran®, Azasan®) and 6- Mercaptopurine (6-MP, Purinethol®, Mercaptopurine®)

These two drugs, which are chemically related, may take a number of months to exert a clinical effect. They are traditionally prescribed for children and adolescents with either Crohn's disease or ulcerative colitis who have been unresponsive to, or dependent upon, high- dose corticosteroids. Recent research (in part sponsored by ROFY) has demonstrated that it is beneficial to include 6-MP as an initial treatment in addition to prednisone in newly diagnosed moderately ill children with Crohn's disease. Azathioprine and 6- MP are therefore increasingly being used to induce and maintain Crohn's disease remission while also allowing corticosteroid dosage to be reduced or eliminated. These agents have also been shown to have the potential to close fistulae arising from the diseased bowel in Crohn's disease. Children on these drugs can occasionally develop severe allergic reactions, pancreatitis, abnormal liver function or a decrease in their white blood cell count. These problems are all reversible with discontinuation of the medication. Commercially available tests now allow monitoring of the level of 6-MP metabolites in the blood, providing physicians with an additional tool for improving the safe use of these medications.

Cyclosporine (Sandimmune®) and Tacrolimus (FK506, Prograf ®)

These potent medications can be used to treat severe or fulminant cases of colitis. Patients may note a rapid and dramatic lessening of symptoms, but unless children are weaned to other agents, such as 6-MP, relapses are common. Cyclosporine and tacrolimus can also be used to control complications of IBD such as fistulae or certain ulcerative skin rashes. Complications can include toxic effects to the kidneys, high blood pressure, and increased susceptibility to severe viral infection. When these medications are used, the patients blood levels must be carefully monitored.

Antibiotics

Antibiotics, administered either orally or intravenously, are effective therapy for IBD patients with fever, inflammatory abdominal masses, or abscesses.

Symptomatic Agents

Antidiarrheal or antispasmodic agents are only rarely used in children and adolescents with IBD. They are not usually effective and problems may arise with their use.

Infliximab (Remicade®)

The first of a new class of "biological" medications for IBD to be released commercially in the United States is infliximab (a form of "blocking" antibody). It interferes with TNF, an important immunologic signaling protein that promotes the inflammation of Crohn's disease and ulcerative colitis. Given as a series of intravenous infusions, infliximab is used to treat patients with corticosteroid dependent or intractable Crohn's disease, as well as those with chronic draining fistulas. While less well studied, it may also have a role in treating select patients with intractable ulcerative colitis. Studies on the long term effects of infliximab in children are currently underway.

Adalimumab (Humira®)

This is another "blocking antibody" that interferes with TNF. It's effects are similar to infliximab, but the agent is given as an injection under the skin rather than an infusion.

New Agents

A number of new and exciting treatments for both Crohn's disease and ulcerative colitis are currently under clinical investigation. In fact, more than 70 novel agents are in various stages of development. These agents may be available to individual patients in need as part of research studies, or at times under "compassionate use" protocols. Questions about these and all other medications or novel treatments should be discussed with your physician.

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"What is IBD?" is from our brochure, The Inside Story.