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Humira (Adalimumab): Better Choice for The Treatment of Crohn's Disease Who Were Intolerant to Remicade (Infliximab)

Crohn's is a chronic inflammatory disease(The other inflammatory bowel disease is ulcerative colitis.) of the gastrointestinal tract, usually the small intestine. It affects about 500,000 people in the United States and tends to cluster in families. Symptoms include abdominal pain, diarrhea, fever and weight loss. The cause is unknown, but most scientists think the immune system over-reacts to viruses or bacteria in the intestine triggering an ongoing, uncontrolled inflammation.

The disease causes swelling, redness, even sores (ulcers) in the intestines. These ulcers can create a hole in the wall of the intestine. Both the swelling and scar tissue from the sores can block the passage of food through the intestines.It may recur at various times over a lifetime.Crohn's disease is also called ileitis or enteritis.Crohn's disease affects males and females equally. It appears to run in some families, with about 20 percent of people with Crohn's disease having a blood relative with some form of inflammatory bowel disease.

Crohn's disease almost invariably affects the gastrointestinal tract. As a result, most gastroenterologists classify the disease by the affected areas. Ileocolic Crohn's disease, which affects both the ileum (the last part of the small intestine that connects to the large intestine) and the large intestine, accounts for fifty percent of cases. Crohn's ileitis, affecting the ileum only, accounts for thirty percent of cases, and Crohn's colitis, affecting the large intestine, accounts for the remaining twenty percent of cases, and may be particularly difficult to distinguish from ulcerative colitis.

Researchers from the University of Michigan Medical School have identified a genetic mutation that increases the risk of Crohn's disease. The discovery provides the first insight into the complex causes and mechanisms of this chronic condition.

Some people who have the disease have long periods without symptoms, even without getting treatment. Others with more severe disease will need long-term treatment or even surgery.Active Crohn's disease can stunt the growth of a child.The treatment of Crohn's disease depends on how bad it is and where it is in your GI tract. When the disease is mild, medicines called salicylates may help. Certain antibiotics are also used to treat mild Crohn's disease.

Also, some medications used to treat Crohn's disease in children — such as corticosteroids — can retard growth. The key is to treat the Crohn's disease and get it into remission to minimize the use of corticosteroids. Also, other medications that don't affect growth can be used in place of corticosteroids.

If you have diarrhea, avoid foods that have a laxative effect, such as raw fruits and concentrated fruit juices. Resting your bowel by not eating solid foods for a few hours can help. Instead of eating during this time, just drink clear liquids, such as the rehydrating fluids (sports drinks) you can buy at the store. As the diarrhea improves after a few hours, eat frequent small, bland meals. Gradually over a couple of days return to your usual diet.

Don't use a lot of stimulants, such as caffeine (coffee, tea, chocolate, soft drinks) and nicotine. Avoid milk products if they cause symptoms.

The Food and Drug Administration (FDA) today approved Humira (adalimumab) to treat adult patients with moderately to severely active Crohn's disease, a chronic inflammatory disease of the intestines. Humira is a human-derived, genetically-engineered monoclonal antibody (a protein that can be produced in large quantities in a manufacturing plant). The product acts to reduce excessive levels of human tumor necrosis factor (TNF) alpha, which plays an important role in abnormal inflammatory and immune responses. The labeling includes a boxed warning about potential serious adverse events.

"Humira has been shown to reduce signs and symptoms, and to induce and maintain clinical remission of Crohn's disease in patients who have had an inadequate response to conventional therapy, and in those patients who did not benefit from treatment, or who were intolerant to previous treatment with Remicade (infliximab) therapy," said Dr. Douglas Throckmorton, Deputy Director of FDA's Center for Drug Evaluation and Research. "Today's approval provides patients and their health care providers with a new treatment option.

The product has been studied in 1,478 patients with Crohn's disease in four clinical trials comparing the drug to a placebo (contains no active ingredient) and two longer term extension studies.

The labeling of Humira includes a boxed warning, the strongest type of label warning, that use of this product has been associated with serious, sometimes fatal, infections, including cases of tuberculosis, opportunistic infections, and sepsis. Before initiating Humira treatment, patients should be evaluated for tuberculosis risk factors and tested for latent tuberculosis infection. Other serious adverse events reported by Humira users include lymphoma, a type of cancer. The most frequent adverse events included upper respiratory infections, sinusitis, and nausea.

Humira requires subcutaneous injections (under the skin) to initiate treatment for Crohn's disease, and maintenance treatment is administered as one injection every other week.

Humira was previously approved for the treatment of three autoimmune diseases: rheumatoid arthritis, a chronic inflammation of the joints; psoriatic arthritis, which causes joint swelling and scaly skin; and ankylosing spondylitis, a systemic rheumatic disease that affects the spine and sacroiliac joints. Humira is manufactured by Abbott Laboratories, Abbott Park, Ill.