Crohns Disease Drugs
09.21.09
Thirty-two years ago Ginger Gray walked into her doctor’s office complaining of abdominal pain, diarrhea, severe weight loss, and overwhelming joint pain. At 19, she hadn’t grown an inch since the sixth grade. But her doctor said there was nothing physically wrong with her, and even suggested she seek psychiatric counseling.
Fortunately for Gray, she sought another physician’s opinion.
Based on tests he conducted, the doctor recommended the 4-foot-11-inch Pennsylvania resident begin full-time treatment for Crohns disease.”Crohns disease robbed me of my stamina,” Gray says. “It took two years for me to fully regain my strength and weight so that I could begin working again.”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 Crohns 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 Crohns disease who have not found relief with other treatments.
“We recognized that [Remicade] had such a dramatic effect on patients,” says Barbara Matthews, M.D., a medical officer in FDA’s Center for Biologics Evaluation and Research, “that it was given accelerated approval.”Remicade, which is taken intravenously, can decrease the amount of inflammation along the lining of the intestine.
Clinical trials also show that Remicade is effective in closing fistulas (abnormal passages or sores between the bowel and skin). Although not a cure, the drug reduces the symptoms in patients who have not responded well to traditional treatments.”This is an exciting development for two reasons,” says R. Balfour Sartor, M.D., professor of medicine, microbiology and immunology at the University of North Carolina, and chairman of the National Scientific Advisory Committee for the Crohn’s & Colitis Foundation of America (CCFA). “It is the first therapy for Crohns disease derived by molecular techniques, and it has the possibility of improving the quality of life for [Crohn's] patients.”
But Sartor also cautions that the long-term toxic effects of Remicade are unknown and that the drug is not needed by every Crohns disease patient. “Two-thirds of the people will have near immediate results,” he says, “but only those patients who do not respond to other therapies” are eligible to take the drug. The next step is to maintain a patient’s remission after the drug’s initial effect has worn off.
Currently, studies are being done to better define the risks and longer-term benefits of Remicade because drug reactions and potential adverse effects from suppressing tumor necrosis factor require further clarification. Crohns disease is one of two major types of inflammatory bowel diseases (IBD)–the general term for diseases that cause inflammation in the intestines–and has no cure and a high rate of recurrence following treatment.
It usually occurs in the lowest portion of the small intestine (ileum), and the large intestine (colon or bowel), but it can occur in other parts of the digestive tract. Crohn’s usually involves all layers of the intestinal wall.
The disease can be difficult to diagnose because its symptoms, which include chronic diarrhea, crampy abdominal pain, loss of appetite, and weight loss, often mimic those of the other IBD type–ulcerative colitis–which affects only the colon. (See “Is It Crohn’s Disease?”)
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Tags: Abdominal Pain, Antibody, Clinical Trials, Crohn Disease, Crohn S Disease, Crohns Disease, Disease Drugs, Dramatic Effect, Food And Drug Administration, Ginger Gray, Inflammation Of The Bowel, Infliximab, Intestine, Joint Pain, Medical Officer, Pennsylvania Resident, Remicade, S Center, Sixth Grade, Stamina, Time Treatment, Tumor Necrosis Factor