Posts Tagged ‘Chronic Inflammatory Disease’

New Treatment for Crohns Disease

11.21.09

Until now, treatment for Crohn’s has relied on surgery and anti-inflammatory and other drugs also used to treat other conditions. In August 1998, the Food and Drug Administration licensed the first treatment specifically for Crohn’s disease, an incurable and sometimes debilitating inflammation of the bowel.

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.

Crohns Disease

08.20.09

It is also known as regional enteritis is a chronic, episodic, inflammatory bowel disease (IBD) that affects any part of the entire wall of the bowel or intestines. Crohns disease can affect any part of the gastrointestinal tract from mouth to anus; as a result, the symptoms of Crohns disease vary among afflicted individuals.

The disease is characterized by areas of inflammation with areas of normal lining between in a symptom known as skip lesions. The main gastrointestinal symptoms are abdominal pain, diarrhea (which may be bloody, though this may not be visible to the naked eye), constipation, vomiting, weight loss or weight gain. Crohns disease can also cause complications outside of the gastrointestinal tract such as skin rashes, arthritis, and inflammation of the eye.

The disease was independently described in 1904 by Polish surgeon Antoni Lesniowski and in 1932 by American gastroenterologist Burrill Bernard Crohn, for whom the disease was named. Crohn, along with two colleagues, described a series of patients with inflammation of the terminal ileum, the area most commonly affected by the illness.

Crohns disease affects between 400,000 and 600,000 people in North America. Prevalence estimates for Northern Europe have ranged from 27–48 per 100,000. Crohns disease tends to present initially in the teens and twenties, with another peak incidence in the fifties to seventies, although the disease can occur at any age. Although the cause of Crohns disease is not known, it is believed to be an autoimmune disease that is genetically linked. The highest relative risk occurs in siblings, affecting males and females equally. Smokers are three times more likely to get Crohns disease.

Unlike the other major types of IBD, there is no known drug based or surgical cure for Crohns disease. Treatment options are restricted to controlling symptoms, putting and keeping the disease in remission and preventing relapse. Crohns disease is a chronic inflammatory disease of the intestines. It primarily causes ulcerations (breaks in the lining) of the small and large intestines, but can affect the digestive system anywhere from the mouth to the anus. It is named after the physician who described the disease in 1932.

It also is called granulomatous enteritis or colitis, regional enteritis, ileitis, or terminal ileitis. Crohns disease tends to be more common in relatives of patients with Crohns disease. It also is more common among relatives of patients with ulcerative colitis. Crohns disease is related closely to another chronic inflammatory condition that involves only the colon called ulcerative colitis.

Together, Crohns disease and ulcerative colitis are frequently referred to as inflammatory bowel disease (IBD). Ulcerative colitis and Crohns disease have no medical cure.

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