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Biotechnology for
Inflammatory Bowel Disease (2007)
The disease
Inflammatory bowel disease is the result of inappropriate and persistent over stimulation of the intestinal mucosa by the immune system. Its cause is currently unknown. Inflammation of the wall of the digestive tract can be observed along with the development of ulcers, and it can cause diarrhoea, abdominal pain and cramps, blood in faeces, fatigue, fever, weight loss and nutritional deficiency. It is a chronic disease marked by attacks of variable intensity which alternate with more or less complete and prolonged phases of remission.There are two major groups in this disorder, Crohn’s disease, which affects the entire gastrointestinal tract, and Ulcerative colitis, which affects only the colon and the rectum.
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How many people are affected ?
The number of new cases per annum in the European Union is estimated at 25 000 for Crohn’s disease and 47 500 for ulcerative colitis. The total number of cases in the European Union for both groups is respectively 450 000 (Crohn’s disease) and between 450 000 and 900 000 (Ulcerative colitis).
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How many people die from the disease?
There is a significant excess mortality rate for patients with Crohn’s disease in comparison with the general population. The only identified risk factor is advanced age at the time of diagnosis. Survival of patients with ulcerative colitis, on the other hand, is greater or equal to that of the general population.
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Living with the disease
Patient's life is impaired in all functional categories in comparison with those in a reference population. The principal areas of patient concern are the possible necessity for a colostomy (artificial anus), of developing a cancer, the side effects of the drugs required, the unpredictable nature of the disease and an eventual surgical operation.The disability rate for patients with inflammatory bowel disease is high, particularly for those with Crohn’s disease.
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Treatment
Témoignage patient de
Classical appoaches
The object of long-term treatment for inflammatory bowel disease is to prevent relapses and avoid dependency on corticosteroids used during attacks. It consists of an aminosalicylate derivative, 5-ASA and in the most severe forms of unspecific immunosuppressive agents (azathioprine or methotrexate) Surgery is reserved for complications in Crohn’s disease and for failure of medical treatment in ulcerative colitis.
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Biotech revolutions
Understanding the role of TNF a (Tumour Necrosis Factor, a molecule produced by various cells in the body) in the inflammatory process of intestinal lesions in patients with Inflammatory bowel disease has enabled the development of new drugs. These new biological agents, whose role is to inhibit TNF a and prevent it from acting to excess, have shown spectacular results.
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Drugs currently available
Two anti-TNF a monoclonal antibodies have been licensed. For the present, only one is used in the case of inflammatory bowel disease, infliximab. This treatment is effective for Crohn’s disease (response rate > 60% for active forms resistant to conventional treatment and for forms with fistulae) and for ulcerative colitis (response rate > 60% for active forms resistant to conventional treatment).
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Number of patients treated
The use of anti-TNF agents appears to be justified in approximately 5% of patients with Crohn’s disease and approximately 3% of those with ulcerative colitis, or for the 25 member countries of the European Union, an estimate of at least 40 000 people per annum.
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Future
Regulatory approval for 3 other anti-TNF antibodies is being sought and products whose role is to inhibit the action of other agents in the inflammatory process are currently under development.
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Costs to society
There are no statistics for the entire European Union, but it can be estimated that the average annual cost (direct and indirect) is between €5,000 and €10,000 per patient with inflammatory bowel disease, or €4.5 to €13.5 billion for the whole of the European Union.
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