Remicade (infliximab) is a genetically engineered antibody that blocks inflammation caused by a protein called tumor necrosis factor. After clinical trials showed benefit from Remicade treatment within a two-to-four week period following a single dose, FDA approved the drug for patients with moderate to severe Crohn’s disease who have not found relief with other treatments. 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, which affects an estimated one million Americans. 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. Crohn’s disease is a chronic, incurable, inflammatory bowel disease that causes diarrhea, cramping and abdominal pain, and in some cases, abnormal connections (fistulas) leading from the intestine to the skin. “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.

The type of symptoms you have and how bad they are will determine the treatment you need. Aminosalicylates (such as sulfasalazine or mesalamine). These medicines help manage symptoms for many people who have Crohns disease. Antibiotics such as ciprofloxacin and metronidazole may be tried if aminosalicylates are not helping your symptoms. These medicines work especially well for disease in the colon.

Antibiotics are also used to treat fistulas, which are abnormal connections or openings between two organs or parts of the body. But 50% of fistulas come back when antibiotics are stopped. Corticosteroids (such as budesonide or prednisone) may be given by mouth for a few weeks or months to control inflammation. But corticosteroids have serious side effects, such as high blood pressure, osteoporosis, and increased risk of infection. Budesonide causes remission in mild or moderate Crohns disease of the ileum and the right colon. It does not work as well as prednisone or other corticosteroids. But it also does not have as many side effects as other corticosteroids. The long-term side effects are not well known, so your doctor will probably not have you take it for a long time.

Prednisone may help if budesonide does not. Medicines that suppress the immune system (called immunomodulator medicines), such as azathioprine (AZA), 6-mercaptopurine (6-MP), or methotrexate. You may take these if the medicines listed above do not work, if your symptoms come back when you stop taking corticosteroids, or if your symptoms come back often, even with treatment.

If you have tried all the medicines listed above and none of them have worked, your doctor may give you a tumor necrosis factor (TNF) antagonist such as infliximab (Remicade). This drug may work for people who have not had any success with other medicines for Crohns disease. Infliximab is also used to treat fistulas if antibiotics do not heal them. Another TNF antagonist that may be used to treat Crohns disease is adalimumab (Humira). It may work for people for whom infliximab has stopped working and for people who have a bad reaction to infliximab.

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