This program is supported by an educational grant from Janssen Biotech Inc, and a sponsorship from Takeda.

Transcription

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2 This program is supported by an educational grant from Janssen Biotech Inc, and a sponsorship from Takeda.

3 Objectives Today s discussion will address the following topics: 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

4 Audience Poll 1 Which best describes you? I have been diagnosed with Crohn s disease. A friend or family member has been diagnosed with Crohn s disease. I have been diagnosed with ulcerative colitis. A friend or family member has been diagnosed with ulcerative colitis. Other

5 Life With IBD Symptoms, course of disease, and prognosis differ from one person to the next How do you determine your best treatment plan? 1.6with IBD

6 Inflammatory Bowel Diseases ARE NOT Irritable bowel syndrome (IBS) An allergy An immune deficiency ARE Inflammatory = activated immune system in the intestinal tract Chronic = lasts a long time (maybe a lifetime) Treatable

7 Potential Causes of IBD Genetic Predisposition Environmental Triggers Immune System Disturbances

8 The Spectrum of IBD CROHN S DISEASE Patchy, full-thickness inflammation Mouth to anus involvement, mostly end of small intestine and colon Fistulas, abscesses, strictures Extra-intestinal manifestations ULCERATIVE COLITIS Continuous, superficial inflammation Rectal or colorectal Extra-intestinal manifestations Indeterminate Colitis 10%-15%

9 Treatment Goals Improve Quality of Life Disease Monitoring and Prevention Maintenance of Remission Induce remission

10 Historical Treatment Strategies Severe Cyclosporine/Tacrolimus Natalizumab/Vedolizumab Anti-TNF Anti-TNF / Thiopurine/MTX (CD) Moderate Corticosteroids Thiopurine/MTX (CD) Mild Aminosalicylate Induction Maintenance time Disease severity at presentation

11 How Do We Choose Therapies for IBD? Accurate diagnosis Understanding of prognosis Adoption of specific symptom and objective goals for success No pain No urgency Normal labs Healed bowel

12 Factors Influencing Disease Control in IBD Resections Prior failed therapy Steroids Dose-Response Half-life Delivery BMI Sex (M/F) Nutritional status Pharmacogenomics Adherence Smoking Therapy Factors Patient Factors Disease Control Disease Factors Lag time before dx Phenotype Genotype Microbiome Immunology CRP Source: Adapted from Rutgeerts P, et al. Dig Dis 2012;30:

13 Understanding Treatment Options Over-the-counter medications Prescription medications Surgery Complementary and alternative therapies

14 Poll Question #2 My treatment regimen includes: A) Corticosteroids B) Aminosalicylates C) Immunomodulators D) Biologics E) Two or more of the above

15 The IBD Medicine Cabinet Over-the-Counter Antibiotics Aminosalicylates Corticosteroids Immunomodulators Biologics

16 Over-The-Counter (OTC) Medications Over-the-Counter Antibiotics Aminosalicylates Corticosteroids Address symptoms only Anti-diarrheal agents Laxatives Pain Relievers NSAIDs may cause or worsen GI irritation (ibuprofen, Aleve, Motrin, Advil) Important: talk with your physician before taking any OTC medications Immunomodulators Biologics

17 Antibiotics Over-the-Counter Antibiotics Aminosalicylates Corticosteroids Immunomodulators Biologics Benefits Risks Effective in pouchitis, perianal fistulas, abscesses, and in some patients with inflammatory CD, generally not useful for UC Bacterial resistance Associated with flares Side effects include abdominal cramping, Clostridium difficile, and diarrhea

18 Aminosalicylates (ASAs) Over-the-Counter Antibiotics Aminosalicylates Corticosteroids Immunomodulators Benefits Useful in preventing relapses and maintaining remission Generally well-tolerated Formulated to release medication to specific areas of the bowel Most effective in treating UC Risks Few serious side effects 3% allergies/intolerance Biologics

19 Aminosalicylates (ASAs) (cont) Over-the-Counter Antibiotics Aminosalicylates Corticosteroids Immunomodulators Biologics Balsalazide (Giazo,Colazal ) Mesalamine formulations Delayed/Extended release tablets (Lialda,Asacol HD Apriso, Delzicol ) Controlled release tablets (Pentasa ) Rectal suspension (Rowasa ) Rectal suppository (Canasa ) Olsalazine (Dipentum ) oral Sulfasalazine (Azulfidine ) Oral Sulfa Containing Take with folic acid

20 Corticosteroids Over-the-Counter Antibiotics Aminosalicylates Corticosteroids Immunomodulators Biologics Benefits Initially effective in inducing remission in UC and CD Risks Numerous, including Infection Psychosocial impact: sleep disturbance, mood swings Neurological changes Physical appearance: weight gain, skin fragility Growth delays and bone loss Most tapers are too long (or not needed)

21 Corticosteroids (cont) Over-the-Counter Antibiotics Aminosalicylates Corticosteroids Immunomodulators Biologics Budesonide (Entocort, Uceris ) Oral Hydrocortisone (Cortenema, Cortifoam ) Enema, oral, intravenous Methylprednisolone (Medrol ) Oral or intravenous Prednisone Oral

22 Thiopurine Immunomodulators (Azathioprine, 6-MP) Over-the-Counter Antibiotics Aminosalicylates Corticosteroids Immunomodulators Biologics Benefits Older therapies Steroid-sparing agents, used in maintenance Usually taken along with another medication to get patients into remission Once achieved, about 70% of adult patients stay in remission for at least one year Risks Can be individualized (TPMT genotype) Early reactions: fever, pancreatitis Adverse events: low white blood cells, elevated liver tests, infection (viral), lymphoma (EBV-associated)

23 Other Immunomodulators Over-the-Counter Antibiotics Aminosalicylates Corticosteroids Methotrexate Oral and injection Cyclosporine (Neoral ) Oral and intravenous Tacrolimus (Prograf ) Oral and Intravenous Immunomodulators Biologics

24 Biological Therapies Over-the-Counter Antibiotics Aminosalicylates Corticosteroids Immunomodulators Biologics Designer drugs made to specifically block inflammation or stimulate antiinflammatory processes Similar or identical to the actual biologic chemicals that our body makes Benefits Often administered to patients who do not or no longer respond to standard therapies 60%-80% of patients respond to within a few doses Risks Risk of infections, infusion or injection site reactions, psoriasis-like reaction

25 Biological Therapies (cont) Over-the-Counter Antibiotics Aminosalicylates Corticosteroids Immunomodulators Biologics Anti-TNF Adalimumab (Humira ) UC and CD Injection Certolizumab pegol (Cimzia ) CD only Injection Infliximab (Remicade ) CD and UC Intravenous Golimumab (Simponi ) UC only Injection Selective adhesion molecule Natalizumab (Tysabri ) Intravenous, CD only Vedolizumab (Entyvio ) Binds to the alpha4beta7 integrin Intravenous Moderate- severe CD and UC

26 Medication Considerations in Special Populations Each medication presents benefits and risks Children require special considerations 10% with CD or UC are under age 18 and require individualized treatment More clinical trials needed to address efficacy and dosage Treatment approaches largely based on adult experience Some medications, including methotrexate, may be contraindicated in pregnant women (but most are OK)

27 Goals of Surgery Surgery and medication can combine for better quality of life Primary goals of surgery Alleviate complications Alleviate symptoms Achieve best possible quality of life Bowel conservation Illustration of ostomy site

28 Types of Surgery in IBD Crohn s Disease Strictureplasty Resection of small intestinal segment Colectomy (partial or complete) Proctocolectomy Diverting colostomy or ileostomy CD cannot be cured with surgery Ulcerative Colitis Proctocolectomy (removal of the colon and rectum) With ileostomy Restorative (ileoanal or J pouch)

29 Elective and Emergency Surgery Crohn s Disease Elective Stricture Failure of medication to control disease Formation of a fistula or abscess Dysplasia Emergency Perforation of the bowel Intestinal obstruction or blockage Ulcerative Colitis Elective Failure of medication to control disease Dysplasia/cancer (rare) Emergency (rare) Perforation of the colon Intestinal obstruction Toxic megacolon Excessive bleeding

30 Risks of Surgery Crohn s Disease Complications, as with any surgery Recurrence of symptomatic disease Psychological implications for those with a stoma Ulcerative Colitis Complications, as with any surgery Potential complications specific to IPAA include: Pouchitis Small bowel obstruction Pouch failure (8%-10% of patients) Difficulty getting pregnant Psychological implications for those with ileostomy

31 The Critical Role of Nutrition Diet = the food you eat on a daily basis Nutrition = how your body uses nutrients from your diet No known diet alters inflammation Certain foods for individual patients may exacerbate symptoms during a flare

32 Good Nutritional Choices Good nutrition is key to: Medications being more effective Healing, immunity, and energy levels Preventing or minimizing GI symptoms Recommended Foods Carbohydrates with more soluble fiber (oat brans, legumes, barley) Recommended Supplements A daily multivitamin Protein (eggs, lean meats, smooth nut butters) Vitamin B12 (monthly injection may be given to patients with ileitis) Well-cooked fruits and vegetables Calcium, Vitamin D Healthful fats (canola or olive oil) Folic acid

33 Complementary and Alternative Medicine (CAM) What is CAM? Group of diverse medical and healthcare systems, practices and products not presently part of conventional medicine. Examples: Natural products (supplements, vitamins, probiotics) Mind and body medicine (meditation, acupuncture, yoga) Massage Limited scientific evidence on benefits in IBD; however, some therapies/products are being studied in IBD and are showing promising results Talk to your doctor Not FDA-regulated Important to seek out good data to minimize potential risk Should complement, not replace, traditional therapies Before trying anything, talk to your doctor about potential benefits and risks Tell your doctor everything you are taking or trying

34 Probiotics and IBD Good bacteria with claims to restore the balance in the gut Limited studies on effectiveness- shown to prevent and treat pouchitis, prevent relapses of C Diff and prevent antibiotic associated diarrhea Examples of various strains VSL#3, Escherichia coli Nissle 1917 (Mutaflor ), Lactobacillus acidophilus (Flora- Q ) Important to discuss with physician before initiating treatment

35 Please Don t Forget Clinical Trials We won t have new therapies without clinical trials They are ethically designed Many offer cross-over from one arm (placebo) to another and open label experimental therapies Clinical Trials on CCFA.org ResearchMatch ClinicalTrials.Gov CCFA Partners Talk to your doctor

36 Do your homework! Complementary and alternative therapies continue to be popular Some have good data to show they work Some have good data to show they don t Work = relieve symptoms 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! Discuss with your healthcare team Consider second opinions if you are not satisfied

37 Communicating with the Healthcare Team The most satisfied patients take part in talks and decisions about their healthcare. Talk with your doctor in an open and honest way. This can lead to better and safer healthcare decisions. Be prepared for your visits to your healthcare team Make a prioritized list Tell your doctor all of the treatments you are taking Helps foster trust Reduces chance of interactions/side effects Improves adherence

38 Evolving Strategies for Treatment in IBD More individualized disease characterization Prediction of drug effectiveness and side effects before prescribed Development of decision aids to help with individual understanding Titration of therapy using serial monitoring and adjustments At home disease monitoring for real time control and understanding

39 Evolving Treatment Strategy for IBD: Treating to Achieve a Target Goal Monitoring Assessment of target Assessment target Treat to Target Assessment of target Source: CCFA webcast 2014: What s Best for Me? Treatment Options in IBD David Rubin, MD.

40 Understanding Risk of Therapies Keep in Context of Risk of Disease Recognize Individual Variations: Disease type and location Age and age of diagnosis Sex (M/F) Prior treatment response Allergies/Intolerances Smoking history Siegel CA, et al. Presented at DDW; May Abstract Su1312.

41 Specific Examples of Customized Treatment Approaches in IBD TPMT testing for thiopurine use: predicts likelihood of toxicity and aids in proper dosing Distinction between younger and older patients related to risks of infection with anti-tnf biological therapies Distinction between males and females when making specific treatment choices Use of therapeutic monitoring of therapies to help with monitoring and ongoing response to therapies

42 Treatment Options in IBD: Key Points Understand your IBD - Diagnosis and Prognosis Know the goals of your treatment strategies Combine symptom management with disease control Create checklists for your care Adopt a monitor strategy

43 References References CCFA website: CCFA website: Rubin, DT. Treatment Options in IBD webcast: treatmentswebcast.html Understanding IBD Medications and Side Effects, Patient Brochure online The Facts About Inflammatory Bowel Diseases, CCFA Publication- Additional Resources Treatment and Self-Management: Community Site: Irwin M. and Suzanne R. Rosenthal IBD Resource Center (IBD Help Center): or Contributors Gil Melmed, MD- Cedars Sinai Medical Center David Rubin, MD- University of Chicago Medical Center American Gastroenterological Association Institute CCFA Staff: Catherine Soto, National Manager, Education Programs

44 Question-and-Answer Session If your question is not answered during the program, please call our IBD Help Center, Monday-Friday, 9:00 AM- 5:00 PM EST at: (888) Or us at

45 CCFA Resources Irwin M. and Suzanne R. Rosenthal IBD Resource Center (IBD Help Center) M-F, 9:00 AM-5:00 PM ET Phone: Educational webcasts: Connect with other patients CCFA Community website: Support groups and Power of Two (peer mentors): GI Buddy Online tracking tool and mobile app Local educational events, visit:

46 AGA Resources Patient Center: Patient guide to GI procedures: Patient guide to GI Conditions and Diseases:

47 Get Involved!