Biotechnology Healthcare - November/December 2008 - (Page 13) CLINICAL BURDEN Symptoms and progression IBD is most commonly diagnosed in late adolescence and early adulthood, although it may be made at any age. Common symptoms include abdominal pain, diarrhea, fever and weight loss. Nongastrointestinal symptoms include skin lesions and inflammation of the eye. Untreated, it can lead to intestinal blockage and colorectal cancer. Common first-line treatments for IBD have several side effects — one of the reasons that almost two thirds of ulcerative colitis patients admitted in a Crohn’s and Colitis Foundation survey to being not fully compliant with their treatment regimens (Loftus 2006). In this study, treatment satisfaction highly correlated with adherence. Percentage of patients reporting side effects (real-world use) Traditional agent Hair loss Diarrhea Headache Cramps/ distress Nausea Patient experience I % remission with this treatment (“always” or “most of the time”) I % “satisfied” or “very satisfied” with this treatment Fever Delayed-release mesalamine Mesalamine enemas Balsalazide Mesalamine suppositories Sulfasalazine Controlled-release mesalamine Enteric release sulfasalazine Olsalazine Source: Loftus 2006 12 3 6 4 5 7 9 4 11 11 16 7 12 11 4 8 11 2 9 1 18 10 4 8 16 17 17 11 12 11 13 4 4 1 2 1 4 4 9 4 2 0 1 0 3 0 6 0 46 39 29 41 55 33 65 62 73 74 67 63 65 63 75 87 Et cetera: Up to 75 percent of patients with Crohn’s disease will require surgery to remove a portion of the colon. Surgery is not a cure, because disease usually recurs. About 20 percent of those with ulcerative colitis will require colectomy, which is curative. Psychological disorders, including anxiety and depression, are believed to be highly prevalent in patients with IBD and may impair their quality of life beyond the disease itself (Mikocka-Walus 2007). DRUGS IN DEVELOPMENT Role of biotechnology treatments Infliximab was the first biologic to treat IBD, and the excitement over initial studies of its effectiveness spawned much research into new treatments. About 80 experimental drugs for IBD are in the pipeline, according to the Crohn’s and Colitis Foundation of America. Pharmaceutical Research and Manufacturers of America lists 15 biologics in development for digestive diseases (not including agents being studied for kidney, liver, and pancreatic cancers), though the chart below totals 17 indications; 2 products in the pipeline are under investigation for 2 indications. Four biologics being studied for digestive diseases are already on the market for other conditions. Et cetera: The average cost per dose for infliximab (Remicade) and adalimumab (Humira) may range from $1,500 to $2,200 (UnitedHealthcare 2005). The cost-effectiveness of the therapies has yet to be determined. REFERENCES Burt CW, Schappert SM. Ambulatory care visits to physician offices, hospital outpatient departments, and emergency departments: United States, 1999–2000. National Center for Health Statistics. Vital Health Stat. 2004;13(157). CDC (U.S. Centers for Disease Prevention and Control). Inflammatory Bowel Disease. Sept. 24, 2007. «http://www.cdc.gov/nccdphp/dach/ibd. htm#5». Accessed Oct. 22, 2008. Collins JG. Prevalence of selected chronic conditions: United States, 1990–1992. National Center for Health Statistics. Vital Health Stat. 1997;10(194). Feagan BG, Vreeland MG, Larson LR, Bala MV. Annual cost of care for Crohn’s disease: a payor perspective. Am J Gastroenterol. 2000;95: 1955–1960. Kozak LJ, Owings MF, Hall MJ. National Hospital Discharge Survey: 2002 annual summary with detailed diagnosis and procedure data. National Center for Health Statistics. Vital Health Stat. 2005;13(158). Loftus CG, Loftus EV Jr, Harmsen WS. et al. Update on the incidence and prevalence of Crohn’s disease and ulcerative colitis in Olmsted County, Minnesota, 1940–2000. Inflamm Bowel Dis. 2007;13:254–261. Loftus EV. A practical perspective on ulcerative colitis: patients’ needs from aminosalicylate therapies. Inflamm Bowel Dis. 2006;12:1107–1113. Mikocka-Walus AA, Turnbull DA, Moulding NT, et al. Controversies surrounding the comorbidity of depression and anxiety in inflammatory bowel disease patients: a literature review. Inflamm Bowel Dis. 2007;13: 225–234. PhRMA (Pharmaceutical Research and Manufacturers of America). 2008 Report. «http://www.phrma.org/files/Biotech%202008.pdf». Accessed Oct. 23, 2008. Rubenstein JH, Chong RY, Cohen RD. Infliximab decreases resource use among patients with Crohn’s disease. J Clin Gastroenterol. 2002;35: 151–156. UnitedHealthcare. Data on file. 2005. Biologics in the pipeline for digestive diseases Number of indications in development, by phase 8 7 2 0 Clinical Phase 1 Phase 2 Phase 3 0 Preregistration Source: PhRMA 2008 NOVEMBER/DECEMBER · BIOTECHNOLOGY HEALTHCARE 13 http://www.cdc.gov/nccdphp/dach/ibd.htm#5 http://www.cdc.gov/nccdphp/dach/ibd.htm#5 http://www.phrma.org/files/Biotech%202008.pdf
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