We will discuss: Inflammatory Bowel Diseases. Life With IBD. What Are the Potential Causes of IBD?

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1 We will discuss: Similarities and differences between Crohn s disease (CD) and ulcerative colitis (UC) Risks and benefits of medication, surgery, and integrative treatments in inflammatory bowel diseases (IBD) Impact of treatment adherence on disease management and quality of life Talking with your health care team about your treatment plan Life With IBD More than 1.6 million Americans are currently living with IBD Symptoms, course of disease, and prognosis differ from one person to the next How do you determine your best treatment plan? Inflammatory Bowel Diseases Are Not Irritable bowel syndrome (IBS) An allergy Are Inflammatory = activated immune system in the intestinal tract Chronic = lasts a long time (maybe a lifetime) An immune deficiency Treatable What Are the Potential Causes of IBD? Genetic Predisposition 20%-25% of patients have a close relative with IBD Immune System Abnormalities Environmental Factors Ulcerative Colitis (UC) Crohn s Disease (CD) Indeterminate Colitis 10%-15% An inappropriate reaction by the body s immune system Infections, antibiotics, microbiome nonsteroidal anti-inflammatory drugs (NSAIDs),diet, smoking, stress 1

2 Comprehensive IBD Management Minimize treatment toxicity Treat complications Treat inflammation Provide emotional support IBD Management Goals Control symptoms Prevent cancer Maintain remission Improve quality of life Ensure adequate nutrition Understanding Treatment Options Over-the-counter medications Prescription medications Surgery Complementary and alternative therapies Early, Consistent Treatment = Increased Chance of Staying Well Health Disease Prevention Subclinical Inflammation Prevention of Symptomatic Disease Symptomatic Inflammation Complications Prevention of Complications Prevention of Recurrence Disability The IBD Medicine Cabinet Over-The-Counter (OTC) Medications Address symptoms only Anti-diarrheal agents Laxatives Pain Relievers NSAIDs may cause or worsen GI irritation Important: talk with your physician before taking any OTC medications Benefits Effective in pouchitis, perianal fistulas, abscesses, and in some patients with inflammatory CD Transient use Risks Bacterial resistance Associated with flares Side effects include abdominal cramping, Clostridium difficile, and diarrhea 2

3 (cont) Ciprofloxacin (Cipro,Proquin ) Risk of tendonitis/achilles rupture Metronidazole (Flagyl ) Metallic taste Nausea Must avoid alcohol Pentasa (cont.) Sulfasalazine, Colazal, Dipentum Rowasa (enema) Asacol, Apriso, Lialda Canasa (suppository) (cont) Systemic (Oral or IV) Prednisone (Deltasone ) Prednisolone Methylprednisolone (Medrol ) Local Budesonide (oral) (Entocort, UCERIS ) Hydrocortisone (rectal) Enema (Cortenema ) Foam (Proctofoam HC ) Suppository (Anucort HC ) (ASAs) Benefits May prevent relapses and maintain remission Generally well-tolerated Formulated to release medication to specific areas of the bowel Most effective in treating UC, but weak/no benefit for Crohn s disease Risks Few serious side effects Can be expensive Benefits Rapid and potent for inducing remission Not so effective for maintaining remission Risks (many) Infection Sleep disturbance Mood swings Tremors Weight gain/redistribution Fragile skin/bruising Growth delay Bone loss/osteoporosis Hip necrosis Glaucoma/cataracts Diabetes Pros Steroid-sparing Maintain remission: Once achieved, about 70% of adult patients stay in remission for at least one year Often taken with another medication Steroids Immunomodulator Biological + Immunomodulator Cons Slow to act (3 mos) Early reactions: fever, nausea, headaches, rash, hair loss, pancreatitis Adverse events: low white blood cell counts, elevated liver tests, infection (viral), lymphoma, cervical cancer, skin cancer (not melanoma) 3

4 (cont) Azathioprine (Imuran, Azasan ) 6-Mercaptopurine (Purinethol ) Methotrexate Estimated Annual Cost for 70 kg Patient $18,000 $16,000 $14,000 $12,000 $10,000 $8,000 $6,000 $4,000 $2,000 $0 List Price for Non-Biologic IBD Medications prednisone budesonide azathioprine 6-MP MTX (PO) MTX (SQ) sulfasalazine balsalazide Lialda Asacol Delzicol Apriso Pentasa Steroids 5'ASA's Walgreens Target Kmart Costco Kroger Walmart HealthWarehouse CVS Safeway Rite-Aid All prices per GoodRx.com, 9/3/19 Proteins (usually antibodies) engineered to block specific (immune system) molecules. Similar to proteins that our body normally makes Benefits Often effective in patients not responding to other therapies c. 60% of patients respond Improvement can be rapid Risks (anti-tnf agents) Infections Infusion/injection site reactions Serum sickness Autoimmune-like reaction Psoriasis-like Lupus-like Multiple sclerosis-like (cont) Anti-TNF Infliximab (Remicade ) Adalimumab (Humira ) Certolizumab pegol (Cimzia ) (Crohn s) Golimumab (Simponi ) (UC) Interleukin-12 and 23 Antagonist Ustekinumab (Stelara ) (Crohn s) Integrin Antagonist Natalizumab (Tysabri ) (Crohn s) Vedolizumab (Entyvio ) A biosimilar product is a biological product that is approved based on a showing that it is highly similar to an FDA-approved biological product, known as a reference product, and has no clinically meaningful differences in terms of safety and effectiveness from the reference product. Anti-TNF for IBD: Inflectra TM (infliximab-dyyb) & Renflexis TM (infliximab-abda) have biosimilarity to infliximab (Remicade ) Amjevita TM (adalimumab-atto), has biosimilarity to adalimumab (Humira), Source: nts/ucm htm - accessed 4/13/16 Estimated Annual Cost for 70 kg Patient $140,000 $120,000 $100,000 $80,000 $60,000 $40,000 $20,000 $0 List Price for IBD Biologicals Walgreens CVS Target Kmart Costco Kroger Safeway Rite-Aid Walmart HealthWarehouse Blink Health All prices per GoodRx.com or WellRx.com, 9/3/19, and *exclude infusion center costs* 4

5 Estimated Annual Cost for 70 kg Patient $120,000 $100,000 $80,000 $60,000 $40,000 List Price for IBD medications Relative Merits of Biologicals vs Conventional Medications* Cost Convenience Steroids Biologicals $20,000 Efficacy $0 prednisone budesonide azathioprine 6-MP MTX (PO) MTX (SQ) sulfasalazine balsalazide Lialda Asacol Delzicol Apriso Pentasa Infliximab* Inflectra* Renflexis* Adalimumab Certolizumab Golimumab Natalizumab* Vedolizumab* Ustekinumab Risk Steroids 5'ASA's Biologicals Walgreens Target Kmart Safeway HealthWarehouse CVS Costco Kroger Rite-Aid Walmart Blink Health * excluding aminosalicylates Risks of Anti-TNFs & If 10,000 patients were treated for 1 year Event Estimated Frequency Lymphoma (baseline) 2/10,000 Lymphoma (on immunomodulators (IM s)) 4-9/10,000 Lymphoma (on anti-tnf with prior IMs) 4-9/10,000 Hepatosplenic T-cell lymphoma <1/10,000 Death from sepsis (lower for younger patients) 40/10,000 Tuberculosis 5/10,000 Less medication seems like less risk of medication toxicity, HOWEVER: Less effective medications more flares More flares more steroids More steroids more toxicity Table adapted from Siegel CA. In Inflammatory Bowel Disease: Translating Basic Science Into Clinical Practice. Wiley, Treatment Strategy Top-down Strategy Early use of biologic as initial treatment Induces rapid clinical response May enhance quality of life Proactive Bottom-up" Strategy Sequentially escalated treatment for remission and maintenance More cost-effective Reactive + Immune Suppressors Azathioprine 6-MP Methotrexate Anti-inflammatory Drugs Surgery Surgery Immune Suppressors Azathioprine 6-MP Methotrexate Anti-inflammatory Drugs Early Late Severe Moderate Mild Medication Considerations in Special Populations Children: 10% of people affected by CD or UC are under the age of 18 and require individualized treatment Few clinical trials have addressed efficacy and dosage in children Treatment approaches largely based on adult experience Pregnant Women: Methotrexate contraindicated Certolizumab is the only anti-tnf that does not cross the placenta Older Patients Higher absolute risk of cancers avoid immunomodulators? Infections can be more dangerous avoid steroids? Thinner bones avoid steroids? 5

6 Clinical Trials: The Basics Phase I Phase II Phase III Safety Efficacy (how well a treatment works) Compares new treatment to placebo treatment Trials are appropriate for many different types of people Specific requirements vary by trial Fewer trials for children and older adults The more people who take part in clinical trials, the faster we will find better ways to treat and potentially cure IBD First step: Join CCFA Partners! Visit or for more information on clinical trials in your area. Chance of Needing Surgery Crohn s Disease: 66%-75% Ulcerative Colitis: 25%-40% Elective and Emergency Surgery Reasons for Surgery: Elective Failure of medication to control disease (Pre) Cancer Stricture (Crohn s) Fistula / Abscess (Crohn s) Emergency Bowel perforation Intestinal obstruction Excessive bleeding Toxic megacolon (UC) Types of Surgery in IBD Crohn s Disease Strictureplasty Resection of small intestinal segment Colectomy (partial or complete) Proctocolectomy Diverting colostomy or ileostomy Unlike UC, CD cannot be cured with surgery Ulcerative Colitis Proctocolectomy (removal of the colon and rectum) With ileostomy Restorative (ileoanal or J pouch) Disease is cured once the colon is removed Risks of Surgery Crohn s Disease Complications, as with any surgery Anesthesia risks Infection Poor wound healing Bowel perforation/obstruction Psychological implications for those with a stoma Recurrence of disease: Endoscopic: 70-90% at 1 year Symptomatic: 30% at 5 years Ulcerative Colitis Complications, as with any surgery Psychological implications for those with ileostomy Potential complications specific to IPAA include: Incontinence Pouchitis (50% by 10 years) Small bowel obstruction Pouch failure (8%-10%) Female infertility (25-50%) Complementary and Alternative Medicine (CAM) According to National Center for Complementary and Alternative Medicine, several categories of CAM (practices can fit into more than one category) Natural products (e.g., supplements and probiotics) Mind and body medicine (e.g., meditation and acupuncture) Manipulation and body-based practices (e.g., massage and spinal manipulation) Applicable to IBD patients because Inability of conventional medicines to perfectly control disease Difficult symptoms of IBD Chronic nature of illness with need for chronic therapy Side effects of conventional medication, especially steroids 6

7 What Forms of CAM Do IBD Patients Use? (N=1332) Probiotics and IBD Good bacteria that restore balance to the enteric microbiota-bacteria in the intestines Limited studies show they can: Prevent and treat pouchitis Improve UC response to mesalamine at high doses Prevent relapses of C. difficile colitis Prevent antibiotic associated diarrhea. Various strains studied VSL#3 Escherichia coli Nissle 1917 (Mutaflor ) Lactobacillus acidophilus (Flora-Q ) Discuss with physician before initiating probiotics Hilsden, et al. Am J Gastroenterol Other Alternatives Helminthic therapy (worms) Pig whipworm used to treat both UC and CD Show promise for symptom control and healing inflamed tissue Clinical trials being conducted with FDA oversight Curcumin, extract from turmeric Pilot study with UC and CD patients: ASA dosage reduction in UC patients and symptomatic improvement in CD patients 1 Large trial in quiescent UC: 2 relapses in treated group versus 8 in ASA-only group within 6-month treatment period 2 Larger scale prospective studies needed Fish oil supplements containing omega-3 fatty acids 3 May reduce pain and inflammation when added to standard therapy Clinical trial results are inconsistent, no clear recommendation Weigh the Risks and Benefits Complementary and alternative therapies continue to be popular Some have good data to show they relieve symptoms Some have good data to show they don t Important to seek out good data to minimize potential risk Choose well-researched options Consider the qualifications of the information resource Alternative therapies should not replace prescription medications! Tell your doctor everything you are taking 1. Holt, et al. Dig Dis Sci. 2005; 2. Hanai, et al. Clin Gastroenterol Hepatol. 2006; 3. Feagan, et al. JAMA Diet and IBD Including good nutrition in your diet improves health, quality of life and long-term outcomes No known diet alters inflammation Certain foods for individual patients may exacerbate symptoms during a flare Carefully track how your diet and symptoms correlate: Diet During a Flare A low-residue diet often prescribed (esp. for Crohn s with strictures) Keep well-hydrated Eat smaller, more frequent meals Add nutrition supplements if appetite is poor (fortified shakes) Low-Residue Foods Grains Plain cereals White rice Refined pasta Avoid whole grains Vegetables Potatoes (no skin) Well cooked Dairy As tolerated or additional sources Fruits Fruit juices (except prune) Apple sauce Bananas Meat and protein Well cooked Avoid beans, nuts, seeds 7

8 Flare Prevention Potential triggers of flares Stress/sleep deprivation Lapses in taking medication as prescribed Recent use of certain medications: Nonsteroidal anti-inflammatory drugs (NSAIDs) What you can do Take all IBD medications regularly as directed Eat a well-balanced diet Maintain good sleep hygene Stop smoking Use Flare Symptoms Tracker: Drugs don t work in patients who don t take them C. Everett Koop, MD Adherence generally associated with improved outcomes Decreased risk of disease progression Reduced inflammation and increased healing of GI lining Possible decreased risk of colorectal cancer Evidence demonstrates patients who continue their maintenance medications are less likely to experience flares Adherence is Complex and Multifactorial To Increase Treatment Adherence Cognitive impairment Treatment of asymptomatic disease Inadequate follow-up or discharge planning Psychological problems, especially depression Missed appointments Adherence Barriers to care or medications Complexity of treatment Cost of medication, co-payment, or both Poor provider-patient relationship Remain informed and educated Simplify the treatment regimen if possible Continue taking the medications Find support for emotional and social issues Friends and family Medical social workers CCFA support groups, Community site: Medication side effects Patient s lack of belief in benefit of treatment Patient s lack of education about the disease Treatment Options in IBD: Key Points Prescription medications can dramatically improve the quality of life in IBD Some serious, but very rare side effects with some medications Benefits most likely outweigh the risks Adherence is importance in maintaining remission Over-the-counter medications offer symptom relief CAM treatments used in combination with prescribed medications can offer symptom relief Always tell your doctor everything you are taking Surgery can be a very good alternative for some patients Clearly understand the pros and cons so that you can make a decision that is right for you Contributors CCFA Patient Education Committee Sunanda Kane, MD, Mayo Clinic Faten Aberra, MD, University of Pennsylvania Raymond Cross, MD, University of Maryland Annie Feagins, MD, University of Texas Southwestern Jeffrey Katz, MD, UH Case Medical Center Patricia Kozuch, MD, Thomas Jefferson University Robert McCabe, MD, Minnesota Gastroenterology Sharmeel Wasan, MD, Boston Medical Center 8

9 References and Resources References CCFA website: National Center for Complementary and Alternative Medicine: Regueiro MD. Managing IBD: Taking Charge of Your Disease webcast: Siegel CA. Balancing the Risks and Benefits of Treatment webcast: Kane S. IBD Self-Management: The AGA Guide to Crohn s Disease and Ulcerative Colitis. Bethesda, MD: AGA; Additional Resources Treatment and Self-Management: Community Site: Information Resource Center: or info@ccfa.org Question-and-Answer Session 9