The fundamental concept is that immune-mediated disease results from a selective deficiency in the mucosal immune system of a susceptible individual. The disease process is initiated in the intestinal tract, although the effects of the disease process manifest themselves in tissues and organs far from the intestinal tract. The disease process can be reversed by interfering with this critical step in the expression of immune-mediated disease.
Although a great deal is known about the immune system, the study of immune-mediated disease mechanisms has been slow to yield information that can be used to develop drugs to treat these diseases. A combination of a genetically susceptible individual and an environmental trigger is necessary for disease expression. According to a number of studies, genes interact with the environment to cause immune-mediated diseases in genetically susceptible individuals. Microbes, such as viruses, bacteria, and parasites are highly implicated in the pathogenesis of immune-mediated diseases.
The NIH estimates that immune-mediated disease affects 14 – 18 million people in the U.S and that 80% of these patients are women.