Understanding Myositis Medications
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1 Understanding Myositis Medications 2015 TMA Annual Patient Conference Orlando, Florida Chester V. Oddis, MD University of Pittsburgh Director, Myositis Center
2 Disclosures Mallinckrodt: Research Grant Genentech: Research Grant Idera: Consultant
3 General Concepts: Myositis Therapies Myositis is inflammatory and autoimmune
4 General Concepts: Myositis Therapies Myositis is inflammatory and autoimmune Drugs will: Decrease inflammation (e.g. steroids) Suppress the immune system
5 General Concepts: Myositis Therapies Myositis is inflammatory and autoimmune Drugs will: Decrease inflammation (e.g. steroids) Suppress the immune system Borrowed from oncologists Methotrexate, imuran, cytoxan and rituximab
6 General Concepts: Myositis Therapies Myositis is inflammatory and autoimmune Drugs will: Decrease inflammation (e.g. steroids) Suppress the immune system Borrowed from oncologists Methotrexate, imuran, cytoxan and rituximab Borrowed from transplant surgeons Cyclosporine, tacrolimus, MMF (CellCept)
7 Myositis Medications Glucocorticoids (steroids) Immunosuppressive Agents Combinations of drugs IVIg (gamma globulin) Biologic agents
8 Myositis Medications Glucocorticoids (steroids)
9 Drug Glucocorticoids Dose Begin at 1 mg/kg/day, often in divided doses and generally not exceeding 80 mg daily. Taper by 20-25% of existing dose monthly until 5-10 mg/day reached. Hold tapering for total duration of therapy of 6 to 12 months. Level of evidence for use in myositis Retrospective studies Moghadam-Kia, Exp Rvw Clin Immun, in press
10 Aggarwal/Oddis, Curr Rheum Rep, 2011
11 Myositis Medications Glucocorticoids (steroids) Immunosuppressive Agents Combinations of drugs
12 Medications After Prednisone Most physicians choose glucocorticoids as their initial treatment Methotrexate is often given next or even concomitantly with steroids Azathioprine may be given using same rationale
13 Rationale Behind Medications Published studies Experience of the treating physician Art > Science Rheumatology vs. Neurology Methotrexate: rheumatologist Azathioprine: neurologist
14 Drug Glucocorticoids Methotrexate Azathioprine Dose Begin at 1 mg/kg/day, often in divided doses and generally not exceeding 80 mg daily. Taper by 20-25% of existing dose monthly until 5-10 mg/day reached. Hold tapering for total duration of therapy of 6 to 12 months. Begin at mg/wk (oral or subq); increase to 25 mg/wk Begin at 50 mg/day (oral) with dose escalation by mg increments every 1-2 weeks up to 1.5 mg/kg/day. Increase up to mg/kg/day in severe cases. Level of evidence for use in myositis Retrospective studies Retrospective uncontrolled cohort studies Retrospective uncontrolled cohort studies Moghadam-Kia, Exp Rvw Clin Immun, in press
15 Aggarwal/Oddis, Curr Rheum Rep, 2011
16 Beyond Steroids Mtx Imuran Many physicians still struggle with this in treating myositis patients
17 Beyond Steroids Mtx Imuran Many physicians still struggle with this in treating myositis patients Including me and the other experts speaking at this conference
18 Beyond Steroids Mtx Imuran Many physicians still struggle with this in treating myositis patients Including me and the other experts speaking at this conference Look at published studies
19 Aggarwal/Oddis, Curr Rheum Rep, 2012
20 Beyond Steroids Mtx Imuran Many physicians still struggle with this in treating myositis patients Including me and the experts Look at published studies Case series with very few controlled trials
21 Drug Glucocorticoids Methotrexate Azathioprine Mycophenolate mofetil Cyclosporine Tacrolimus Cyclophosphamide Dose Begin at 1 mg/kg/day, often in divided doses and generally not exceeding 80 mg daily. Taper by 20-25% of existing dose monthly until 5-10 mg/day reached. Hold tapering for total duration of therapy of 6 to 12 months. Begin at mg/wk (oral or subq); increase to 25 mg/wk Begin at 50 mg/day (oral) with dose escalation by mg increments every 1-2 weeks up to 1.5 mg/kg/day. Increase up to mg/kg/day in severe cases. Begin at mg twice daily (oral) with increase by 250 to 500 mg increments every 1-2 weeks to target dose of mg/day. Begin at 50 mg twice daily; increase up to mg twice daily Begin at 1 mg twice daily; increase to reach trough level of 5-10 ng/ml Begin at mg/day (oral) working up to mg/kg/day. Level of evidence for use in myositis Retrospective studies Retrospective uncontrolled cohort studies Retrospective uncontrolled cohort studies Retrospective uncontrolled studies Retrospective controlled studies Retrospective controlled studies Prospective uncontrolled studies on myositis-ild; case reports on myositis Moghadam-Kia, Exp Rvw Clin Immun, in press
22 Choosing the Right Drug How does your doctor decide how to treat you Simple decisions More complex decisions
23 Targets of Myositis Muscle (myositis) Skin GI tract: difficulty swallowing
24 Myositis Medications Glucocorticoids (steroids) Immunosuppressive Agents Combinations of drugs IVIg (gamma globulin)
25 Drug Glucocorticoids Methotrexate Azathioprine Mycophenolate mofetil Cyclosporine Tacrolimus Cyclophosphamide Intravenous immune globulin (IVIg) Dose Begin at 1 mg/kg/day, often in divided doses and generally not exceeding 80 mg daily. Taper by 20-25% of existing dose monthly until 5-10 mg/day reached. Hold tapering for total duration of therapy of 6 to 12 months. Begin at mg/wk (oral or subq); increase to 25 mg/wk Begin at 50 mg/day (oral) with dose escalation by mg increments every 1-2 weeks up to 1.5 mg/kg/day. Increase up to mg/kg/day in severe cases. Begin at mg twice daily (oral) with increase by 250 to 500 mg increments every 1-2 weeks to target dose of mg/day. Begin at 50 mg twice daily; increase up to mg twice daily Begin at 1 mg twice daily; increase to reach trough level of 5-10 ng/ml Begin at mg/day (oral) working up to mg/kg/day. Begin at 1-2 grams/kg/month over 1-2 days continuing for 3-6 months depending on response Level of evidence for use in myositis Retrospective studies Retrospective uncontrolled cohort studies Retrospective uncontrolled cohort studies Retrospective uncontrolled studies Retrospective controlled studies Retrospective controlled studies Prospective uncontrolled studies on myositis-ild; case reports on myositis Double-blind, placebo controlled trial Moghadam-Kia, Exp Rvw Clin Immun, in press
26 Targets of Myositis Muscle (myositis) Skin GI tract: difficulty swallowing Joint pain (arthritis) May get treated like you have rheumatoid arthritis
27 Targets of Myositis Muscle (myositis) Skin GI tract: difficulty swallowing Joint pain (arthritis) Lung (ILD) Shortness of breath Inflammation in lung tissue Fibrosis (scar tissue)
28 Treatment of ILD in Myositis Patients Steroids (prednisone) still the initial treatment Cyclophosphamide and azathioprine used early or in steroid-resistant cases with variable results CellCept is being increasingly used Cyclosporin A and tacrolimus (medications used to prevent rejection of transplanted organs) Maybe even some biologic agents like rituximab
29 Myositis Medications Glucocorticoids (steroids) Immunosuppressive Agents Combinations of drugs IVIg (gamma globulin) Biologic agents
30 Drug Rituximab Etanercept Infliximab Level of evidence for use in inflammatory myopathy Double-blind (improvement in IMACS definition of improvement) One placebo-controlled trial of etanercept with significantly longer median time to treatment failure. Retrospective uncontrolled studies for infliximab Utility in myositis limited by negative studies as well as potential for inducing PM and DM Tocilizumab Abatacept Sifalimumab (anti-interferon) * Interferon is an inflammatory cytokine Case reports Ongoing clinical trial (ARTEMIS) Early study showed some clinical improvement
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Treatment of Rheumatoid Arthritis: The Past, the Present and the Future Lai-Ling Winchow FCP(SA) Cert Rheum(SA) Chris Hani Baragwanath Academic Hospital University of the Witwatersrand Outline of presentation
Ethnic Differences in PK and PD of Anti-Rheumatic Drugs
2010 China-Japan Symposium on Global Clinical Trials and Ethnic Factors May 28 th, 2010, JW Marriott Hotel Beijing Ethnic Differences in PK and PD of Anti-Rheumatic Drugs Shinichi Kawai, MD, PhD Division
Lupus. Fast facts. What is lupus? What causes lupus? Who gets lupus?
Lupus Systemic lupus erythematosus, referred to as SLE or lupus, is sometimes called the "great imitator." Why? Because of its wide range of symptoms, people often confuse lupus with other health problems.
Long-term follow-up of sporadic inclusion body myositis treated with intravenous immunoglobulin: a retrospective study of 16 patients
Long-term follow-up of sporadic inclusion body myositis treated with intravenous immunoglobulin: a retrospective study of 16 patients C. Dobloug, R. Walle-Hansen, J.T. Gran, Ø. Molberg Section of Rheumatology,
ACTEMRA (tocilizumab)
RATIONALE FOR INCLUSION IN PA PROGRAM Background Actemra is an agent in the class of drugs known as biologic disease modifiers. It is used to treat adult onset rheumatoid (RA) arthritis, polyarticular
Adrenocorticotropic hormone gel in patients with refractory rheumatoid arthritis: a case series
International Journal of Clinical Rheumatology For reprint orders, please contact: reprints@futuremedicine.com Adrenocorticotropic hormone gel in patients with refractory rheumatoid arthritis: a case series
Evolving therapies for posterior uveitis. Infliximab (Remicade) Infliximab: pharmacology. FDA-approved monoclonal antibody therapy Target
Evolving therapies for posterior uveitis Sam Dahr, M.D. September 17, 2005 Midwest Ophthalmology Conference Infliximab (Remicade) FDA approved for Crohn s disease, rheumatoid arthritis, and psoriatic arthritis
Fml Limits. Azathioprine (Imuran) 50mg, 75mg, 100mg - $26.85 Cyclosporine, 25mg, 100mg. $ Leflunomide (Arava) 10mg Tablet - $144.
MEDICATION COVERAGE POLICY PHARMACY AND THERAPEUTICS ADVISORY COMMITTEE POLICY: Rheumatoid Arthritis (RA) P&T DATE: 2/15/2017 CLASS: Rheumatology/Anti-inflammatory Disorders REVIEW HISTORY 2/16, 5/15,
Evidence-Based Medicine
PML in the Biologic Era: Where We Stand Eamonn Molloy MD MS FRCPI St Vincent s University Hospital Dublin, Ireland Evidence-Based Medicine Calabrese LH, Molloy ES, Huang D, Ransohoff RM. Arthritis Rheum
Medication Policy Manual. Topic: Xeljanz, tofacitinib Date of Origin: January 21, 2013
Medication Policy Manual Policy No: dru289 Topic: Xeljanz, tofacitinib Date of Origin: January 21, 2013 Committee Approval Date: January 19, 2015 Next Review Date: January 2016 Effective Date: April 1,
Proposed Retirement for HEDIS : Disease-Modifying Anti-Rheumatic Drug Therapy for Rheumatoid Arthritis (ART)
Proposed Retirement for HEDIS 1 2020 2 : Disease-Modifying Anti-Rheumatic Drug Therapy for Rheumatoid Arthritis (ART) NCQA seeks public comment on the proposed retirement of the Disease-Modifying Anti-Rheumatic
Sarcoidosis: is there a role for anti-tnf-α?
Sarcoidosis: is there a role for anti-tnf-α? Abstract In severe cases of sarcoidosis treatment can be very difficult. The common treatment strategies might be failing. Tumour necrosis factor (TNF) α therapy
Chapter 4: Steroid-resistant nephrotic syndrome in children Kidney International Supplements (2012) 2, ; doi: /kisup.2012.
http://www.kidney-international.org & 2012 KDIGO Chapter 4: Steroid-resistant nephrotic syndrome in children Kidney International Supplements (2012) 2, 172 176; doi:10.1038/kisup.2012.17 INTRODUCTION This
Case Presentation. A Case from the Clinic. Additional Data. Examination and Data 10/27/2013
Northwestern University Feinberg School of Medicine Treatment of Severe Thrombocytopenia in Systemic Lupus Erythematosus: The Role of New Agents Disclosures: Advisory Board: Incyte Corporation Speaker
Connective Tissue Disorder- Associated Interstitial Lung Disease (CTD-ILD) and Updates
Connective Tissue Disorder- Associated Interstitial Lung Disease (CTD-ILD) and Updates Maria Elena Vega, M.D Assistant Professor of Medicine Lewis Katz School of Medicine at Temple University Nothing to
Fabian Speth 1, Johannes-Peter Haas 1 and Claas H. Hinze 2*
Speth et al. Pediatric Rheumatology (2016) 14:52 DOI 10.1186/s12969-016-0112-6 CASE REPORT Open Access Treatment with high-dose recombinant human hyaluronidase-facilitated subcutaneous immune globulins