Health Maintenance For Your IBD Patient. Quality in HealthCare

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1 Health Maintenance For Your IBD Patient Francis A. Farraye, MD, MSc Clinical Director Section of Gastroenterology Boston Medical Center Professor of Medicine i Boston University School of Medicine Quality in HealthCare To Err is Human and Crossing the Quality Chasm Only half (55%) of adult outpatients receive recommended care regardless of medical setting Overuse, underuse and misuse are all problems Significant deficits in quality of care in the US including preventable errors that led to the deaths of tens of thousands of Americans each year and hundreds of thousands more who suffer or barely escape nonfatal errors Asch SM, et al. NEJM 2006;354: , McGlynn EA, et al. NEJM 2003;348: , Melmed GY et al. Gastro and Hepatol 2013;9:

2 Improving the quality of care you deliver to your patients is possible Health Maintenance in the IBD Patient IBD patients do not receive preventive services at the same rate as general medical patients GI MD/NPs are often the only clinician that the IBD patient will interact with Clarify the limits of your responsibilities with the patient Moscandrew M, et al. Inflamm Bowel Dis. 2009;15(9): Selby L, et al. Dig Dis Sci. 2011;56(3): Sinclair JA, et al. Gastroenterol Clin North Am Jun;41(2):

3 Health Maintenance in the IBD Patient Delegate routine health care issues to the primary care clinician Offer guidance on the unique health maintenance needs in IBD patient on immunomodulators and biologic agents Should certain health maintenance tasks such as vaccinations be the responsibility of the treating gastroenterologist? Moscandrew M, et al. Inflamm Bowel Dis. 2009;15(9): Sinclair JA, et al. Gastroenterol Clin North Am Jun;41(2): Melmed GY. Inflamm Bowel Dis Jan;18(1):41-2. Health Maintenance Overview Vaccinating the IBD Patient The problem Response to vaccines Appropriate vaccines for the IBD patient Surveillance for Colorectal Neoplasia Risks of Cervical and Skin Cancer Bone Health Smoking Cessation Screening for Depression Risks of Radiation Ophthalmologic Evaluation 3

4 Health Maintenance Overview Vaccinating the IBD Patient The problem Response to vaccines Appropriate vaccines for the IBD patient Surveillance for Colorectal Neoplasia Risks of Cervical and Skin Cancer Bone Health Smoking Cessation Screening for Depression Risks of Radiation Ophthalmologic Evaluation The Vaccine Problem Immunomodulators and biologics used to treat IBD puts patients at increased risk for infections Several of these are vaccine preventable Multiple case reports of infections including fulminant hepatitis or fatal varicella IBD patients (like other patients on immunosuppressive therapy) are not being vaccinated appropriately Keene JK et al. Disseminated varicella complicating ulcerative colitis. JAMA 1978;239:45-6. Domm S et al. The impact of treatment with tumour necrosis factor-alpha antagonists on the course of chronic viral infections. Br J Derm 2008;159:

5 The Vaccine Problem Survey of 169 IBD patients 145 on current/previous immunosuppression 28% reported regular flu shots 9% reported receiving pneumovax Common reasons for not getting vaccinated: Lack of awareness Fear of side effects Study of 2076 IBD patients in Spain Only 12% of patients vaccinated against hepatitis B Melmed GY, et al. Patients with inflammatory bowel disease are at risk for vaccine-preventable illnesses. Am J Gastroenterol 2006;101: Loras C et al. Prevalence and factors related to hepatitis B and C in inflammatory bowel disease patients in Spain: a nationwide, multicenter study. Am J Gastroenterol 2009;104: The Vaccine Problem Survey of 108 gastroenterologists (Fall 2009) Poor knowledge regarding the appropriate vaccines to recommend 20-30% would erroneously give live vaccine to immunosuppressed patient 25-35% would erroneously hold live vaccine to immunocompetent patient Wasan SK, Coukos J, Farraye FA. Gastroenterologist knowledge and behavior in vaccinating the inflammatory bowel disease patient. Inflamm Bowel Dis Dec;17(12):

6 GI Physicians Do Not Inquire About Immunization History How Often N(%) Always 20 (18.5) Most of the time 36 (33.3) Half of the time 5 (4.7) Sometimes 40 (37) Never 7 (6.5) Wasan SK, Coukos J, Farraye FA. Gastroenterologist knowledge and behavior in vaccinating the inflammatory bowel disease patient. Inflamm Bowel Dis Dec;17(12): Gastroenterologists Put the Onus for Vaccinations on the PCP Majority thought PCP was responsible for: Determining which vaccinations to give (65%) Administering the vaccine (83%) Wasan SK, Coukos J, Farraye FA. Gastroenterologist knowledge and behavior in vaccinating the inflammatory bowel disease patient. Inflamm Bowel Dis Dec;17(12):

7 PCPs Hesitant to Treat IBD Patients Survey of 61 attendees at a family medicine review course Only 37% of doctors felt comfortable providing primary care to IBD patients across a range of illness severity Only 30% felt comfortable coordinating vaccinations for the immunosuppressed IBD patient Selby L, Hoellein A, Wilson JF. Are primary care providers uncomfortable providing routine preventative care for Inflammatory Bowel Disease patients? Dig Dis Sci 2011;56: GI Responsibility To Our Patients Gastroenterologists are often the primary decision makers for the IBD patient Should take a more proactive role in assuring that patients are vaccinated appropriately May allow for the administration of the appropriate it vaccinations before bf immunosuppressive therapy is initiated Wasan SK, Coukos J, Farraye FA. Gastroenterologist knowledge and behavior in vaccinating the inflammatory bowel disease patient. Inflamm Bowel Dis Dec;17(12):

8 Immune Response in IBD: Will the Vaccine Work? On monotherapy with immunomodulator? Normal immune response compared with controls or patients on 5ASAs On monotherapy with anti-tnf? Diminished immune response compared with controls or patients on 5ASAs Melmed GY, et al. Am J Gastroenterol 2010; 105: Dotan I, et al. Inflamm Bowel Dis Feb;18(2): Fiorino G, et al. Inflamm Bowel Dis Jun;18(6): Agarwal N, et al. Vaccine ;30(8): Immune Response in IBD: Will the Vaccine Work? On combination of immunomodulator and anti-tnf agent? Diminished immune response to vaccine compared to patient on monotherapy with immunomodulator or 5ASAs Mamula P, et al. Clin Gastroenterol Hepatol 2007;5: Lu Y, et al. Am J Gastroenterol 2009;104: Melmed GY, et al. Am J Gastroenterol 2010; 105: Dotan I, et al. Inflamm Bowel Dis. 2012;18(2): Fiorino G, et al. Inflamm Bowel Dis. 2012;18(6): Agarwal N, et al. Vaccine ;30(8):

9 Immune Response in IBD: Will the Vaccine Exacerbate IBD? H1N1 vaccine 575 patients on immunomodulators or anti- TNFs revceived vaccine between 11/09-3/10 in 14 European countries Well tolerated Four weeks after vaccination, absence of flare was observed in 377 patients with CD (96.7%) and 151 with UC (95.6%) Rahier JF, Papay P, Salleron J, et al. H1N1 vaccines in a large observational cohort of patients with inflammatory bowel disease treated with immunomodulators and biological therapy. Gut 2011;60; Summary IBD patients can mount a response to vaccines Diminished immune response in patients on combination therapy of immunomodulator and anti-tnf agent Ideally vaccinate on diagnosis and prior to initiation of immunosuppressive agents IBD disease activity will not be affected by vaccinations Gastroenterologists should take a more proactive role in assuring that patients are vaccinated appropriately 9

10 Vaccinating i the IBD Patient A Practical Guide Recommended Adult Immunization Schedule: United States, Ann Intern Med. 2013;158(3):

11 General Vaccination Considerations in the IBD Patient Titers to check at first office visit: MMR if vaccination history unknown Varicella if vaccination history or history of chicken pox/zoster unknown Hepatitis A except those with evidence of protective titer within 5 years of vaccine administration Hepatitis B except those with evidence of protective titer within 5 years of vaccine administration Vaccinations to administer in specific patient groups regardless of immunosuppressive drug use Tdap HPV Influenza (yearly) Pneumococcal Hepatitis A (if not immune) Hepatitis B (if not immune) Meningococcal Vaccinations to consider if NO plans to start immunosuppressive therapy in 4-12 weeks: MMR (if not immune) Varicella (if not immune) Zoster (if age 60 or older) Wasan, SK et al. A practical guide to vaccinating the IBD patient. Am J Gastroenterol Jun;105(6): Definition of Immunosuppressed Rx with glucocorticoids ( > prednisone 20mg/day equivalent for 2 or more weeks, and within 3 months of stopping) Rx with effective doses of 6MP/azathioprine or recent discontinuation within previous 3 months Rx with methotrexate or recent discontinuation within previous 3 months Rx with infliximab, adalimumab, certolizumab, or natalizumab or recent discontinuation within the previous 3 months. Significant protein-calorie malnutrition Sands BE et al. Guidelines for immunizations in patients with inflammatory bowel disease. Inflamm Bowel Dis 2004;10:

12 Inactivated Vaccine Recommendations (Regardless of Immunosuppression) Td/Tdap q 10 years HPV- 3 doses (0, 2, 6 months) for males* and females years Influenza (injection) annually Pneumococcal 1-2 doses (one time revaccination after 5 years if immunosuppressed) Hepatitis A- 2 doses Hepatitis B- 3 doses Check post-vaccine titers 1 month after last dose If no response, then vaccinate with double dose (or with combination hepatitis A/B) Meningococcal vaccine if risk of exposure Wasan, SK, et al. A practical guide to vaccinating the IBD patient. Am J Gastroenterol Jun;105(6): *Ann Int Medicine. 2013;158: Inactivated Vaccine Recommendations (Regardless of Immunosuppression) Td/Tdap q 10 years HPV- 3 doses (0, 2, 6 months) for males* and females years Influenza (injection) annually Pneumococcal 1-2 doses (one time revaccination after 5 years if immunosuppressed) Hepatitis A- 2 doses Hepatitis B- 3 doses Check post-vaccine titers 1 month after last dose If no response, then vaccinate with double dose (or with combination hepatitis A/B) Meningococcal vaccine if risk of exposure Wasan, SK, et al. A practical guide to vaccinating the IBD patient. Am J Gastroenterol Jun;105(6): *Ann Int Medicine. 2013;158:

13 Live Vaccine Recommendations Herpes Zoster Prevaccination Titer? Before IMs? Already on IMs No Contraindicated 1 3 mo before start Varicella Yes Contraindicated 1 3 mo before start t Biologic: contraindicated <0.4 mg/kg/wk MTX: OK <3.0 mg/kg/d AZA: OK <1.5 mg/kg/d 6-MP: OK <14 d steroid: OK Contraindicated Family Vaccination Yes Yes AZA, azathioprine Wasan SK et al. Am J Gastroenterol. 2010;105:1231. The IBD Patient Leaving the Country Live Vaccines Yellow fever Measles mumps rubella Oral typhoid Oral polio Intranasal influenza TB Bacillus Calmette Guerin (BCG) Inactivated Vaccines Japanese encephalitis Rabies vaccine Oral typhoid Oral polio Intranasal influenza Hepatitis B Hepatitis A Human papilloma virus (HPV) Meningococcal Tetanus diphtheria (Td) Tetanus diphtheria acellular pertussis (Tdap) Wasan SK, et al. A practical guide to vaccinating the IBD patient. Am J Gastroenterol Jun;105(6):

14 Initial office visit; obtain vaccination history (when did you receive the tetanus, diphtheria, pertussis, human papilloma virus [HPV], influenza, pneumococcal, hepatitis A, hepatitis B, meningococcal, MMR, varicella, herpes zoster vaccines?) Completed vaccination series or up to date on vaccine? Yes No Not sure Evidence of protective antibodies to hepatitis A and B in past 5 years? No? Check titers Not immune If no plans to start immunosuppressive therapy within 4 12 weeks or if not currently on immunosuppressive therapy Recommend*: MMR, varicella, or herpes zoster If no prior history of infection, check titers for MMR, varicella, hepatitis A and B Not immune to MMR/varicella Not immune to hepatitis A or B Regardless of immunosuppressive therapy Recommend*: Tdap (tetanus, diphtheria, pertussis) HPV Influenza Pneumococcal Hepatitis A Hepatitis B Meningococcal *Only certain populations are recommended to receive HPV, herpes zoster, and meningococcal vaccines Wasan SK et al. Clin Gastroenterol Hepatol. 2010;8:1013. Conclusions IBD patients have poor immunization rates Immune response to vaccinations are decreased on combined immunomodulators and anti-tnfs Vaccinations need to be given prior to use of steroids, immunomodulators and anti-tnfs Gastroenterologists need to take a more active role in vaccinating the IBD patient 14

15 PAP Testing PAP Testing in IBD Patients Higher prevalence of abnormal PAP smears in women with IBD Associated with immunomodulator use Risk factors for abnormal PAP: multiple sexual partners, cigarette smoking, OCP use Vaccination for HPV is warranted Kane S, Khatibi B, Reddy D: Higher incidence of abnormal Pap smears in women with inflammatory bowel disease. Am J Gastroenterol 2008, 103: Singh H, Demers AA, Nugent Z, et al.: Risk of cervical abnormalities in women with inflammatory bowel disease: a population based nested case-control study. Gastroenterology 2009, 136:

16 PAP Testing in IBD Patients Document an up-to-date PAP smear prior to immunosuppressive therapy Rule out HPV infection Rule out an abnormal cervical cytology Women on immunomodulators should follow ACOG guidelines for yearly PAP testing Kane S, Khatibi B, Reddy D: Higher incidence of abnormal Pap smears in women with inflammatory bowel disease. Am J Gastroenterol 2008, 103: Singh H, Demers AA, Nugent Z, et al.: Risk of cervical abnormalities in women with inflammatory bowel disease: a population based nested case-control study. Gastroenterology 2009, 136: Skin Cancer 16

17 Non Melanoma Skin Cancer (NMSC) Estimated 3.5 million cases per year of NMSC Increase risk in immunosuppressed IBD patients Thiopurine use (OR: 4.27, CI ) Anti-TNF use (OR: 2.18, CI ) Combined thiopurine and anti-tnf agent (OR: 6.75, CI ) Educate patient on sun protection strategies Consider yearly derm evaluation in patients on immunosuppressive agents, especially in patients older than 50 Long MD, Herfarth HH, Pipkin CA, et al.: Increased risk for non- melanoma skin cancer in patients with inflammatory bowel disease. Clin Gastroenterol Hepatol 2010, 8: Long MD, Kappelman MD, Pipkin CA. Nonmelanoma skin cancer in inflammatory bowel disease: a review. Inflamm Bowel Dis;17(6): Bone Health 17

18 Bone Health In IBD Patients Measure 25 OH Vitamin D levels in all patients Selectively order bone density scan (DEXA) in IBD patients with risk factors for osteoporosis and osteopenia Minimize steroid use when possible, adding steroid-sparing agents where appropriate Supplementation with calcium, vitamin D in all patients on steroids and consider bisphosphonates in appropriate high risk individuals Bernstein CN: Osteoporosis in patients with inflammatory bowel disease. Clin Gastroenterol Hepatol 2006, 4: Smoking Cessation in CD Patients 18

19 Smoking Cessation in CD Patients Increased prevalence of Crohn s disease in smokers Crohn s disease patients who are smokers More severe ileal disease, more frequent flares, an increased need for steroids and immunomodulators and higher rates of surgery Smoking cessation is a crucial aspect in the management of Crohn s patients that is often overlooked Cosnes J. What is the link between the use of tobacco and IBD? Inflamm Bowel Dis. 2008;14 Suppl 2:S14-5. Smoking Cessation in CD Patients Smoking cessation Decreased risk of relapse Decreases need for steroids or immunomodulators Negative effects of smoking are dosedependent Any decrease in the number of cigarettes smoked daily can improve the course of Crohn s disease Cosnes J. What is the link between the use of tobacco and IBD? Inflamm Bowel Dis. 2008;14 Suppl 2:S

20 Depression Depression May affect as many as 15-35% of patients with IBD Predisposing factors: chronic relapsing nature of IBD and some medications used as treatment Appropriate medical treatments are available and well tolerated CCFA Fact Sheet: Health Maintenance Moscandrew M, Mahadevan U, Kane S. General health maintenance in IBD. Inflamm Bowel Dis. 2009;15(9):

21 Depression 1. Over the past month, have you felt down, depressed, or hopeless? 2. Over the past month, have you felt little interest or pleasure in doing things? Nimalasuriya K, Compton MT, Guillory VJ. Screening adults for depression in primary care: A position statement of the American College of Preventive Medicine. J Fam Pract 2009;58: Depression Screening Scores are rated as normal (0-2), mild (3-5), moderate (6-8), and severe (9-12) 21

22 Ophthalmologic Issues in the IBD Patient Ophthalmologic Issues Estimated that approximately 10 % of IBD patients develop ocular problems related to the disease itself or to disease treatment Several ocular manifestations are associated with significant morbidity uveitis, scleritis, episcleritis, corneal disease and keratoconjunctivitis sicca Patients on chronic corticosteroids should be evaluated by an ophthalmologist for glaucoma and cataracts Mintz R, et al. Inflamm Bowel Dis. 2004;10(2):

23 Patient meets criteria for IS therapy Update vaccination status Steroids Immunomodulators Biologics Calcium/vitamin D DEXA Exit strategy Monitor for infection TPMT for thiopurines, CBC, liver enzyme Monitor for infection HBV testing TB testing Monitor for infection IS, immunosuppressant; TPTM, thiopurine methyltransferase; DEXA, dual-energy x-ray absorptiometry; CBC, complete blood count; TB, tuberculosis; HBV, hepatitis B virus Modified from Kane S. Curr Gastroenterol Rep. 2010;12:502. Selected Monitoring Parameters 5-ASAs Corticosteroids Immunomodulators (MTX, 6MP/AZA) Biologics CBC x x x x Liver enzymes x x x Creatinine/Urinalysis/BUN x Eye examination x Opportunistic infections (TB, Hep B, varicella, etc) x x x Immunizations x x x x TPMT Bone mineral density for > 3 months x x 23

24 Ask about vaccines Conclusions Take responsibility to vaccinate your IBD patient Be aware of the risks of cervical, colon and skin cancer Screen for depression, bone and eye disease Limit CT scans where possible Closely monitor your immunosuppressed patients 24