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Speaker Introduction Stephen B. Hanauer, MD Professor of Medicine and Clinical Pharmacology University of Chicago Pritzker School of Medicine Chief of Gastroenterology, Hepatology, and Nutrition University of Chicago Medical Center Chicago, Illinois

Disclosure of Conflicts of Interest Stephen B. Hanauer, MD Dr. Stephen B. Hanauer has affiliations with Abbott Laboratories; Centocor, Inc.; Elan Pharmaceuticals; Ferring Pharmaceuticals; Procter & Gamble; Prometheus Laboratories Inc.; Salix Pharmaceuticals, Inc.; Shire; and UCB Pharma (Consultant, Clinical Research); and Astra Zeneca; McNeil-PPC, Inc.; and Millennium Pharmaceuticals, Inc. (Consultant). Today s Goals Identify lifestyle factors impacting quality of life including: flares, diet, stress and smoking Identify current and emerging treatment strategies for IBD Review the latest research Answer questions

What recommendations do you have for flare prevention and enhancing quality of life? Understanding Triggers for Flares Lapses in taking medications Incorrect dosing of medications Use of nonsteroidal anti-inflammatory drugs (NSAIDS) and antibiotics Diet Stress Smoking

Maintaining Remissions and Preventing Flares What you can do: Take all IBD medications as directed by your doctor Always talk to your doctor before changing medications or dosages Avoid anti-inflammatory medications Don t smoke Know your trigger foods Eat a well-balanced diet How should patients manage and maintain their nutritional sustenance?

Role of Diet and Nutrition in IBD Diet and nutrition are important parts of IBD management No evidence that diet can cause or cure IBD IBD is not related to food allergy but may be worsened by food intolerance Proper diet may Improve symptoms of IBD Promote healing Diet and Nutrition Strategies to Help Control IBD Symptoms Create a food journal Know and avoid your trigger foods Strive for a well-balanced, healthy diet based on: Hydration Adequate nutrient intake Consider vitamin and mineral supplementation

What role does stress play in IBD? What We Know About Stress and IBD No causal link between stress and IBD No personality type linked to IBD Stress can affect the digestive tract Impacts IBD symptoms Further research is needed to determine the effectiveness of stress reduction interventions

What is the impact of smoking on IBD? Smoking and IBD Smoking increases risk and worsens disease course in CD Smoking may reduce the risk for UC Researchers are looking at the anti-inflammatory effects of carbon monoxide Smoking increases risk for many other diseases Not recommended as treatment for IBD Lakatos PL, et al. World J Gastroenterol. 2007;13:6134-6139.

What is the difference between the top-down and bottom-up approach? Current Standard Approach: Bottom-Up

Treating IBD Top-Down : The Future? What are some of the long-term side effects of medication for IBD?

Long-Term Side Effects of IBD Medication The goal of IBD therapy is to keep patients in remission without steroids Corticosteroids can have serious side effects Immunomodulators have a low risk of long-term side effects Important to have monitoring blood tests Anti tumor necrosis factor (TNF) biologics have a small increased risk of infections Generally no increased risk for cancer Azathioprine and 6-mercaptopurine associated with a slightly increased risk of minor skin cancers Crohn's & Colitis Foundation of America. Available at: www.ccfa.org/info/treatment/maintenance. Accessed March 18, 2009. Preventing Complications from IBD Therapies Make sure your immunizations are up to date before starting steroids, immune suppressants or biologics Including Hepatitis A & B, HPV, Pneumonia Yearly influenza vaccines Take calcium and vitamin D supplements with steroids Bone Density tests after 3-6 months on steroids Monitor Blood Counts every 3 months on immune suppressants Blood counts and chemistry evaluation yearly while on medications for IBD

What is the impact of drug therapy for IBD on pregnancy in women and fertility in men? Key Issues in Fertility and Pregnancy IBD has little effect on fertility IBD should be controlled before pregnancy In some instances, IBD can actually improve during pregnancy In most cases, medication schedules can and should be maintained during pregnancy

Pregnancy, Fertility, and IBD Drugs Women Aminosalicylates and corticosteroids appear to be safe Drugs to avoid: Methotrexate Antibiotics Thalidomide Men Drugs to avoid: Sulfasalazine (Azulfidine ) Methotrexate 6-Mercaptopurine (6-MP, Purinethol ) Azathioprine (Imuran, Azasan ) Adis International Limited. Drug Ther Perspect. 2001;17:8-11. What are your recommendations to patients considering complementary and alternative medicine (CAM) and where does the research stand on this?

Evaluating CAM Therapies for IBD For the most part, CAM therapies have not been proven effective in controlled clinical studies Some CAM therapies include: Probiotics Fish oil supplements Green tea It is important to discuss CAM therapies with your doctor before beginning any treatment CAM should not replace prescribed therapies When is surgery considered the next treatment option in IBD patients?

The Surgery Decision Elective surgery Disease that is difficult to treat or manage Intolerable medication side effects Unresponsiveness to medical therapy Persistent symptoms (fatigue, weight loss, pain) Significant dietary restrictions and poor quality of life Emergency surgery Perforations Obstructions Toxic megacolon Surgery for IBD Crohn s Disease Strictureplasty Resection of small intestinal segment Colectomy (partial or complete) Proctocolectomy Unlike UC, CD cannot be cured with surgery Ulcerative Colitis Proctocolectomy With ileostomy Restorative (ileoanal or J pouch) Disease is cured after the colon is removed

What are fistulas and abscesses and how are they treated?

Does the behavior of CD change over time? Behavior of CD Over Time Location of disease does not tend to change over time Behavior of the disease does often change over time Risk of complications can increase with time Stricture Fistula

Can you give us some insight into the cost of IBD? Cost of IBD Both monetary and physical costs of IBD are high Direct costs: $1.4 million outpatient visits per year in US 92,000 hospitalizations per year $534 million spent on IBD prescription medications per year Total medical cost per year: $1.4 $1.8 billion Indirect costs are more difficult to measure Include time lost from work and school Total disability cost per year: $0.4 $0.8 billion Cost of IBD increases with nonadherence to treatment National Institute of Diabetes and Digestive and Kidney Diseases. Available at: www3.niddk.nih.gov/burden_of_digestive_diseases/index.shtml#chapter19. Accessed March 18, 2009.

How do you prevent IBD in children? Preventing IBD IBD is a disease of cleanliness Poor sanitation actually protects against IBD Children need exposure to bacteria Use of antibiotics and anti-inflammatory medications should be limited Hanauer S. Inflamm Bowel Dis. 2006;12:S3-S9.

What can we expect in research in the next year? IBD Research Genetics Several genes linked to both CD and UC Large genome-wide studies continue Biological markers Measurable substances that may help characterize disease Crohn's & Colitis Foundation of America. Available at: www.ccfa.org/about/news/trendsinbasicresearch. Accessed March 31, 2009.

IBD Research: Novel Treatments Over 15 new medications for IBD are currently being studied in clinical trials Novel therapies include: Antibiotics Rifaximin (Xifaxan ) Hormone analogs Teduglutide Interferon beta-1α (Avonex ) Steroids with new delivery systems COLAL-PRED Extracorporeal photopheresis National Institutes of Health. Available at: www.clinicaltrials.gov. Accessed March 31, 2009. Questions and Answers