Future Treatments for Chronic Inflammatory Diseases

What are chronic inflammatory diseases?

Among the most prevalent chronic inflammatory diseases are rheumatoid arthritis and inflammatory bowel disease. Inflammatory bowel disease includes ulcerative colitis and Crohnís disease, which are chronic, relapsing inflammatory diseases of the gastrointestinal tract. While the cause(s) are unknown, there is strong evidence for genetic predisposition. Rheumatoid arthritis is an autoimmune disease resulting in damaging inflammation of the joints. In addition to bone and cartilage destruction, it can also damage the heart and lungs. Although the cause(s) are unknown, hypotheses include infectious triggers and genetic susceptibility. There are also many chronic inflammatory diseases that affect smaller patient populations, and are candidates for drug development under the Orphan Drug Act, which provides tax incentives and marketing exclusivity for successful development of drugs to treat rarer diseases. Behcetís disease is in this category.

What is the financial incentive to develop new treatments for chronic inflammatory diseases?

The incidence of inflammatory bowel disease in the U.S. is between 75 and 150 cases per 100,000 individuals. The incidence among Caucasians is about 4 times that of other races, and the disease is much more common in Northern Europe and North America than in other parts of the world. Rheumatoid arthritis affects almost one percent of the human population, with almost three times as many women diagnosed as men, with the incidence varying from less than 1 percent to almost five percent depending on ethnic background. Analysts estimate that the U.S. market potential for therapeutics to treat inflammatory bowel disease will exceed $2.5 billion in 2010. Estimates of the U.S. market potential for rheumatoid arthritis therapeutics in 2010 are between $9.5 billion and $16.9 billion.

The best known biotechnology-derived products on the market to treat serious, chronic inflammatory diseases are the TNF-alpha inhibitors, including both anti-TNF monoclonal antibodies and TNF receptors/binding proteins. Annual sales of Amgenís Enbrel and Johnson & Johnsonís Remicade are each over $2 billion. Abbott Laboratoriesí Humira produces more than $1 billion annual revenue.

Why are better products needed to treat chronic inflammation?

Because of the high cost of currently available, biotechnology-derived therapeutics, most patients are treated with more conventional regimens, such as methotrexate for rheumatoid arthritis or corticosteroids for Crohnís disease. In contrast, the biotechnology products are quite expensive: the annual cost of treatment with Enbrel is approximately $15,000; the annual cost of treatment with Remicade ranges from $15,000 to $30,000; and the annual cost of the newer product, Humira is approximately $15,000.

A combination of side-effects, very high cost of therapy, and poor effectiveness in many patients creates a very good opportunity for innovative researchers to develop better products to treat chronic inflammatory diseases. Perhaps good science and the incentives of capitalism will improve the outlook for people who have these diseases, and, in the future even prevent the diseases from occurring in the first place.


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