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NEW 2011/2012 CRA Recommendations for the Pharmacological Management of RA with Traditional and Biologic DMARDs: Part

NEW 2011/2012 CRA Recommendations for the Pharmacological Management of RA with Traditional and Biologic DMARDs: Part II Safety. Presenter:. CRA recommendations were supported by the Canadian Institutes of Health Research (CIHR) and matched funds from the CRA.

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NEW 2011/2012 CRA Recommendations for the Pharmacological Management of RA with Traditional and Biologic DMARDs: Part

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  1. NEW 2011/2012 CRA Recommendations for the Pharmacological Management of RA with Traditional and Biologic DMARDs: Part II Safety Presenter:

  2. CRA recommendations were supported by the • Canadian Institutes of Health Research (CIHR) and • matched funds from the CRA. • No pharmaceutical companies were involved in any • phase of guideline development. Disclosures

  3. ABAT = Abatacept ADA = Adalimumab Anti-TNF = Anti-Tumor Necrosis Factor BCG = Bacille Calmette-Guérin CXR = Chest x-ray DMARD = Disease modifying anti-rheumatic drug ETN = Etanercept IFX = Infliximab IGRA = Interferon-gamma release assay LTBI = Latent tuberculosis infection MTX = Methotrexate RCT = Randomized controlled trial RTX = Rituximab TBST = Tuberculin skin test Commonly Used Abbreviations

  4. Briefly summarize how the NEW 2012 CRA safety recommendations for RA were developed. Review 2012 CRA safety recommendations for RA. Highlight available guideline resources and implementation tools. Learning Objectives

  5. The CRA developed recommendations for the pharmacological management of RA with traditional and biologic DMARDs in 2 parts. • Part I: Detailed methodology + 26 RA treatment strategy-driven recommendations with traditional and biologic DMARDs (reviewed separately). • Part II: Thirteen recommendations focusing on specific safety aspects of RA treatment with traditional and biologic DMARDs (reviewed here). Preamble

  6. What is covered? • Perioperative management (2) • Screening for latent tuberculosis before starting biologic therapy (4) • Optimal vaccination practices (3) • Treatment of RA patients with a history of malignancy (4) Scope

  7. Methods for Developing Recommendations

  8. Rheumatologist expert • Patient consumer • General practitioner • Coordinator External Clinical Experts: Johan Askling (Malignancy) Michael Gardam (TB, Vaccination) Pooneh Akhavan, MD FRCPC Claire Bombardier, MD FRCPC Vivian Bykerk, MD FRCPC Glen Hazlewood, MD FRCPC James Pencharz, MD CCFP Janet Pope, MD FRCPC John Thomson, MD FRCPC Carter Thorne, MD FRCPC Anne Dooley, Arthritis Patient Advocate Sharon LeClercq, MD FRCPC Dianne Mosher, MD FRCPC Multidisciplinary Working Group Majed Khraishi, MD FRCPC Boulos Haraoui, MD FRCPC Jean Légaré, Arthritis Patient Advocate Orit Schieir, Project Coordinator Michel Zummer, MD FRCPC

  9. Modified- ADAPTE Framework 1. Define Key Questions A priori from results of a national needs assessment survey 1. Define Key Questions A priori from results of a national needs assessment survey Expanded searches: Public health guidelines, post-marketing surveillance + SLR for malignancy (2008-10) 2. Identification of Guidelines Systematic review (2000-2010) + Grey literature 2. Identification of Guidelines Systematic review (2000-2010) + Grey literature 3. Quality Appraisal of Guidelines Guideline quality – Validated instrument (AGREE) 3. Quality Appraisal of Guidelines Guideline quality – Validated instrument (AGREE) 4. Synthesis of Guidelines Evidence tables of recommendations with supporting evidence 4. Synthesis of Guidelines Evidence tables of recommendations with supporting evidence 5. Adapt/develop recommendations Full working group voting and discussion 5. Adapt/develop recommendations Full working group voting and discussion 6. Extended Review & Endorsement External clinical experts (infectious disease, malignancy) + CRA executive 6. Extended Review & Endorsement External clinical experts (infectious disease, malignancy) + CRA executive 7. Dissemination Educational meetings/ local workshops + support tools 7. Dissemination Educational meetings/ local workshops + support tools 9

  10. Strength of Evidence Bykerk et al. The Journal of Rheumatology 2011; 38:11; doi:10.3899/jrheum.110207

  11. Recommendations

  12. Recommendations reviewed here are intended to be read in conjunction with Part I of CRA Recommendations for RA. • These recommendations address specific safety questions that were identified a priori. They are not intended to cover all safety aspects concerning treatment with traditional and biologic DMARDs. Disclaimer 12

  13. Perioperative Care Bombardier et al. The Journal of Rheumatology 2012; 39:8; doi:10.3899/jrheum.120165

  14. Health Canada Drug Product Database (accessed 04-2011): http://www.hc-sc.gc.ca/dhp-mps/prodpharma/databasdon/index-eng.php Bombardier et al. The Journal of Rheumatology 2012; 39:8; doi:10.3899/jrheum.120165

  15. Latent Tuberculosis Infection (LTBI) Bombardier et al. The Journal of Rheumatology 2012; 39:8; doi:10.3899/jrheum.120165

  16. Risk Factors for Latent Tuberculosis Infection (LTBI) • Close contact with individuals known or suspected to have TB (e.g., family members or people sharing living spaces) • History of active TB or x-ray suggestive of past TB that was not adequately treated • Living in (and/or traveling to) communities with high rates of latent/ active TB • Low income populations (e.g. urban homeless) • Residents of long-term care and correctional facilities • Occupational exposure to high risk groups (e.g. healthcare workers) Latent Tuberculosis Infection (LTBI) Public Health Agency of Canada (PHAC) 2008 Tuberculosis Fact Sheet: http://www.phac-aspc.gc.ca/tbpc-latb/fa-fi/tb_can-eng.php Bombardier et al. The Journal of Rheumatology 2012; 39:8; doi:10.3899/jrheum.120165

  17. Bombardier et al. The Journal of Rheumatology 2012; 39:8; doi:10.3899/jrheum.120165 Latent Tuberculosis Infection (LTBI)

  18. Bombardier et al. The Journal of Rheumatology 2012; 39:8; doi:10.3899/jrheum.120165 Latent Tuberculosis Infection (LTBI)

  19. Bombardier et al. The Journal of Rheumatology 2012; 39:8; doi:10.3899/jrheum.120165 Latent Tuberculosis Infection (LTBI)

  20. Vaccination ✓ Recommended; ideally administer prior to initiating therapy. † Recommended in high-risk groups including residents, travelers or close contact with individuals from hepatitis B endemic areas, illicit drug users, persons engaging in risky sexual behaviors/history of STI, men who have sex with men, chronic liver disease, occupational exposures, frequent blood transfusions. †† Recommended in RA patients > 60 years old. *Methotrexate ≤ 25 mg per week. Bombardier et al. The Journal of Rheumatology 2012; 39:8; doi:10.3899/jrheum.120165

  21. Vaccination * Tetanus + diphtheria toxoids adsorbed + component pertussis (Tdap); tetanus + diphtheria (Td); component pertussis + diphtheria + tetanus toxoids adsorbed (DTaP) Public Health Agency of Canada (PHAC) Canadian Immunization Guide: http://www.phac-aspc.gc.ca/publicat/cig-gci/ p01-eng.php Rahier et al. Rheumatology 2010 . Bombardier et al. The Journal of Rheumatology 2012; 39:8; doi:10.3899/jrheum.120165

  22. Given the limited research evidence for malignancy, recommendations are generally grouped as follows: • Medications that are / should be: • An option (either evidence that there is no increased risk or no theoretical increased risk) • Used with caution due to unknown risks • Used with caution; at least some evidence of  risks Malignancy

  23. Malignancy * Treatment decisions should be made on a case-by-case basis in conjunction with a cancer specialist & the patient. Bombardier et al. The Journal of Rheumatology 2012; 39:8; doi:10.3899/jrheum.120165

  24. Accessing CRA Recommendations?

  25. Journal of Rheumatology Publications • http://jrheum.org/search?fulltext=schieir&journalcode=jrheum%7Cjrheumsupp&submit=yes&x=0&y=0 • Drug monitoring • Health Canada Drug Product Database • http://www.hc-sc.gc.ca/dhp-mps/prodpharma/databasdon/index-eng.php • Health Canada MedEffect Homepage • http://www.healthcanada.gc.ca/medeffect • US FDA MedWatch Safety Alerts for Human Medical Products • http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/default.htm • TB • Public Health Agency of Canada 2007 Canadian Tuberculosis Standards: • http://www.phac-aspc.gc.ca/tbpc-latb/pubs/tbstand07-eng.php • Online TST/ IGRA Interpreter Tool (Version 3.0) • http://www.tstin3d.com/en/calc.html • Vaccination • 2006 Public Health Agency of Canada Canadian Immunization Guide • http://www.phac-aspc.gc.ca/publicat/cig-gci/p01-eng.php Other Useful Links

  26. Expert Consultants RA Guidelines Working Group Dr. Pooneh Akhavan Dr. Vivian Bykerk Dr. Claire Bombardier Mrs. Anne Dooley Dr. Paul Haraoui Dr. Glen Hazlewood Dr. Majed Khraish Dr. Sharon LeClercq Mr. Jean Légaré Dr. Diane Mosher Dr. James Pencharz Dr. Janet Pope Ms. Orit Schieir Dr. John Thomson Dr. Carter Thorne Dr. Michel Zummer For any queries/ comments about CRA recommendations for RA, please contact raguidelines@rheum.ca Acknowledgements Dr. Johan Askling (Malignancy) Dr. Michael Gardam (TB, Vaccination)

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