Practical Risk Management Tools for Patients with IBD. Garth Swanson MD Rush University Medical Center
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1 Practical Risk Management Tools for Patients with IBD Garth Swanson MD Rush University Medical Center
2 IBD Therapy Severity Tysabri Surgery Infliximab, i Adalimumab, Certilizumab Corticosteroids, Immunomodulators (AZA/MTX) 5-ASAs, Budesonide, Antibiotics
3 Risk vs. Benefits Benefits Disadvantages Reduced Risk of disease flares Early promotion of mucosal healing Decreased surgeries and hospitalizations Improved QOL Side effects Cost Majority of patients may not require potent treatment Lichtenstein GR, et al. Inflamm Bowel Dis. 2004;10:S2 S10. Caprilli R, et al. Digestive Liver Dis. 2005;37:
4 Steroids and IBD Role Historically important role in the management of acute disease No maintenance role No beneficial role for doses greater than mg/day For acute disease 40 mg/day x 3 weeks then start taper at 5 mg q 1-2 weeks IV steroids for hospitalized, severely ill patient Efficacy No mucosal healing* Worsening course?risk of increased abscess formation in CD
5 Toxicity of Corticosteroids Osteopenia/osteonecrosis Serious infections Cushing syndrome Growth retardation Behavioral changes Diabetes Cardiovascular complications Limit steroids in IBD
6 Anti-TNF Antibodies Chimeric monoclonal antibody Human recombinant antibody Humanized Fab fragment VL VH Mouse Human No Fc PEG CH 1 IgG1 IgG1 PEG Infliximab Adalimumab Certolizumab pegol PEG = Polyethylene glycol
7 What are the risks of TNF therapy? Infections Tuberculosis; unusual opportunistic infections Malignancies Lymphoma Injection-site reactions Rare complications Neurologic, cardiac, bone marrow suppression, hepatotoxicity
8 Risk of Opportunistic Infections in IBD Mayo Clinic case-controlcontrol study of opportunistic infection 2 drugs listed below OR 12.9 (4.5 37) infliximab OR 4.4 ( ) corticosteroid OR 3.4 ( ) 62) AZA OR 3.1 ( ) any of above vs no drug OR 2.6 ( ) 47) Toruner et al, Gastroenterology 2008
9 Opportunistic Infections on TNF Herpes Simplex 46 Candida albicans 26 Cytomegalovirus 12 Epstein Barr virus 8 Streptococcus 1 E. coli 1 Histoplasma 2 Blastomyces 1 Mycobacterium 3 Cryptococcus 1 7
10 Risk Factors for Serious Infections: The TREAT Registry 10 p < ratio (95% CI) Hazard p = p = p = p = p = IS IS+CS IFX IFX+CS IFX IFX+IS Lichtenstein, DDW Abstract T1039.
11 Risks If 10,000 patients were treated with TNF therapy or AZA/6-MP for 1 year Adopted from Siegel CA, The use of immunomodulators in Inflammatory Bowel Disease, 2007
12 Hepatosplenic T cell Lymphoma First report in early 2000 s in pediatric population of HSTCL in Crohn s patients on biologics and immunomodulators (HSTLC) Universally fatal 2 years Male predominance
13 Hepatosplenic T cell Lymphoma 9 cases in IBD with AZA/6MP alone 15 cases in IBD with patients on TNF therapay, either infliximab (n=13) or adalimumab (n=2) with AZA or 6-MP Age range Most are male (14/15) Infusion 1-24 Has not been reported with monotherapy with TNF Has not been reported with combination therapy with MTX Data on file, Centocor and Abbott, 2009
14 Immunomodulator Azathioprione (AZA) 6-Mercaptopurine (6-MP) Methotrexate (MTX)
15 Azathioprine/6MP in IBD Efficacy/Issues Intolerance/Risks Effective in 50 70% of Bone marrow suppression patients with IBD Pancreatitis 30% failure due to Hepatotoxicity intolerance (15%) or no Nausea response (15%) Myalgias flu like Metabolism issues TPMT symptoms Uses Steroid sparing Post operative prophylaxis Other Risks Lymphoma 4 fold Abnormal PAP / HPV Infection
16 Immunosuppressants in IBD Infections, but also.. Cervical Dysplasia Skin Cancer Osteoporosis Vaccinations
17 Incidence of Abnormal Pap Smears in IBD Abnormal Pap smears associated with both infection and progression to cancer Incidence study of women with IBD and a history of abnormal Pap smears Adjusted for smoking, OCP use and parity Women with IBD were more likely l to have an abnormal Pap Use of azathioprine increased risk 3 fold Kane SV Am J Gastro 2008;103(3):631-6
18 Risk of Abnormal Pap Smears Canadian Case Control Study 19,692 abnormal results matched to 57,898 controls No difference in UC Risk 40% when on steroids & immunosuppressants in CD Singh H. Gastroenterology. 2009;136:
19 Skin Cancer and Immunosuppression Well documented in transplant patients Relative risk of 65 for squamous cell carcinoma and 10 for basal cell carcinoma Relative risk of 5 for SCC in patients with all autoimmune diseases and a relative risk of 1.4 in patients with IBD only
20
21 Preventing Osteoporosis in IBD Check bone density (DEXA or heel scan) Control active disease Weight bearing exercise Supplement calcium and vitamin D (Crohn s disease or steroids) Bisphosphonates h if low bone density Actonel or Fosomax
22 Gender Issues in IBD Reproductive issues Disease-related concerns Women fertility after IPAA or proctocolectomy risk of relapse if disease active at time of conception concern re: body stigma, loss of bowel control Men fertility with sulfasalazine Sperm count with methotrexate Sexuality sexual activity libido and sexual because of dyspareunia, satisfaction after abdominal pain, etc proctocolectomy
23 IBD Medications & Pregnancy Medications that are safe: 5-ASA agents Steroids Low risk of cleft palate Most antibiotics Imuran (Azathioprine) and Purinethol (6-MP) Remicade (Infliximab) MUST BE AVOIDED Methotrexate
24 Recommended Vaccinations Tetanus, Diphteria, Pertusis (Td/Tdap) Booster every 10 years HPV Women age 9-26 Influenza (annually) Pneumococcal Hep A & B MMR* Varicella* Zoster* (if age > 60)
25 Vaccines How are we doing? In 169 patients with IBD 86% of whom were on immunosuppression Vaccination given: 45% tetanus 28% a regular influenza 9% pneumococcal 28% Hep B Melmed et al., Inflammatory Bowel Dis. 2004;10:
26 Recommendations Don t miss the forest for the trees Regularly check BP, Lipids, smoking cessation Screen for Cervical and Skin cancer Check DEXA scans Think about Vaccinations Collaborative Care
27 RUSH IBD Clinic Comprehensive Care General Health Maintenance Surgical Nutritionist Psychologist Colon Cancer Screening Osteoporosis Cervical/Skin screening Vaccinations Biologic Therapy Infusions Managing non-responders Research Clinical Studies in environmental factors (Diet, Stress, Sleep) Clinical trials on future biologic targets
28 Thank you
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This information explains the advice about Crohn's disease that is set out in NICE guideline CG152.
Information for the public Published: 1 October 2012 nice.org.uk About this information NICE guidelines provide advice on the care and support that should be offered to people who use health and care services.