July 27, 2007 The use of biologic agents for the treatment of inflammatory bowel disease (IBD) may benefit patients, but doctors need to consider the potential associated side effects in determining treatment course, according to a consensus paper published in Gastroenterology, the official journal of the American Gastroenterological Association (AGA) Institute. IBD includes Crohn's disease and ulcerative colitis, both frequently disabling diseases that affect approximately one million people both in the U.S. and Europe.
The conference examined the literature on monoclonal antibodies or antibody fragments currently approved by the FDA or likely to be approved in the near future. The participants of the Consensus Development Conference, medical experts in IBD convened by the AGA Institute, sought to answer a series of questions about the treatment of IBD with these biologics based on expert presentations of current scientific knowledge about IBD and subsequent discussion.
Co-chairs of the conference were Stephen B. Hanauer, MD, professor of medicine and clinical pharmacology at the University of Chicago, and Paul Rutgeerts, MD, AGAF, professor of medicine, University Hospital Gasthuisberg, Belgium.
"The management of inflammatory bowel disease has been significantly affected by the development of biologic therapies," according to Dr. Hanauer. "Biologic therapies provide new options and hope for many patients, however they may be accompanied by serious side effects, both when used alone or in combination with other treatments. Gastroenterologists need to review and consider the side effects and significant costs when determining the best treatment course for their patients."
The treatment goal for IBD patients has been to alleviate symptoms associated with these diseases and many gastroenterologists rely on a "step up" or sequential treatment approach in treating their patients depending on the severity of their disease. Research on biologics has shown that for patients in whom traditional therapies may not work, biologics may be appropriate as a first line treatment. However, IBD is a heterogeneous disease and some patients may not respond to biologics, so the appropriate role of these agents in the treatment paradigm is the subject of much discussion.
In determining the appropriate course of treatment for their patients, gastroenterologists need to balance the potential complications of drug treatment (including increased risk for infections and cancer) against the consequences of potential under-treatment of their patients' disease (including poor quality-of-life, complications of disease, and the costs associated with active disease and the treatment of complications). The decision of how to treat patients requires extensive knowledge of treatment options and the patient, including whether intense therapy is needed and who may respond to biologic agents. But many factors remain unknown and many important outcomes remained undefined or poorly quantifiable, such as reliable evidence of disease modification and reduction in disability.
The role of biologics for the treatment of patients with IBD continues to evolve and is dependant on researchers determining the answers to a number of outstanding questions about appropriate markers of prognosis and response, the use of biologics as limited or bridge therapy and its duration, the applicability of biologics early in disease, and the potential of disease modification.
In order to determine the answers to these and other potentially important questions, more research is needed about the natural history of IBD and its complications, as well as the complications biologic therapy. Additionally, long-term data about the effects of biologic therapy on hospitalizations, surgeries and other outcomes must be gathered and the relationship between disease improvement and these outcomes must be studied.
According to the U.S. Food and Drug Administration, biologic therapies are agents that "in contrast to drugs that are chemically synthesized, are derived from living sources (such as humans, animals, and microorganisms). Most biologics are complex mixtures that are not easily identified or characterized, and many biologics are manufactured using biotechnology. Biological products often represent the cutting-edge of biomedical research and, in time, may offer the most effective means to treat a variety of medical illnesses and conditions that presently have no other treatments available."
IBD occurs most frequently in people in their late teens and twenties though it can also develop in children and in the aged. Men and women have an equal chance of getting the disease.
Crohn's disease causes inflammation of the lining and wall of the large and/or small intestine and frequently leads to patients requiring surgery, including the removal of affected portions of the intestines or complete removal of the colon. Ulcerative colitis causes inflammation of the lining of the large intestine. When inflamed, the lining of the intestinal wall is red and swollen, becomes ulcerated, and bleeds. Both diseases cause serious deterioration in quality of life; many patients are unable to work and, given the young age of onset of IBD, many years of productivity are lost.
The cause(s) of IBD are not known, but there are several hypotheses. One possible cause is genetic since 15 percent to 30 percent of patients with IBD have a relative with the disease. There is research underway to find out if a specific gene or a group of genes makes a person more susceptible to getting the disease. Many changes in the body's immune system (body's natural defense system against disease) have been discovered in patients with IBD. What is still unknown is what causes those changes to happen. There is a large amount of research being done in this area. There is little evidence that stress causes IBD. As with other illnesses, stress may aggravate symptoms and require a treatment program.
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