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Abstracts tagged "Adverse events"

  • Abstract Number: 1865 • 2013 ACR/ARHP Annual Meeting

    Complement Activation and Anaphylatoxin Generation In Response To Staphylococcal Protein A Exposure: Ex Vivo and In Vivo Human Studies

    Edward Bernton1, Antonio Polley2, Susan Zondlo2, Lynne Mitchell3 and Dennis Hourcade3, 1Protalex Inc., Summit, NJ, 2QPS Holdings LLC, Newark, DE, 3Division of Rheumatology, Washington University School of Medicine, St. Louis, MO

    Background/Purpose: PRTX-100, a highly-purified GMP staphylococcal protein A (SpA), is currently in clinical trials treating patients with active rheumatoid arthritis (RA). It has been reported…
  • Abstract Number: 1812 • 2013 ACR/ARHP Annual Meeting

    Adverse Events In Connective Tissue Disease-Associated Pulmonary Arterial Hypertension Compared To Idiopathic Pulmonary Arterial Hypertension

    Rennie L. Rhee1, Nicole B. Gabler2, Amy Praestgaard2, Peter A Merkel3 and Steven M. Kawut4, 1Rheumatology, University of Pennsylvania, Philadelphia, PA, 2Department of Biostatistics and Epidemiology, University of Pennsylvania, Philadelphia, PA, 3Division of Rheumatology, University of Pennsylvania and VA Medical Center, Philadelphia, PA, 4Division of Pulmonary, Allergy, and Critical Care, University of Pennsylvania, Philadelphia, PA

    Background/Purpose: Whether the risk of treatment-related adverse events (AEs) in patients with pulmonary arterial hypertension (PAH) differs based on diagnosis, either connective tissue disease (CTD-PAH)…
  • Abstract Number: 1606 • 2013 ACR/ARHP Annual Meeting

    Overview Of The Safety Of Epratuzumab In Systemic Lupus Erythematosus

    Daniel J. Wallace1, Josep Ordi-Ros2, C. Michael Neuwelt3, Kenneth Kalunian4, Michelle A. Petri5, Slawomir Jeka6, Ronald F. van Vollenhoven7, Brian Kilgallen8, Sabine Bongardt9, Caroline Gordon10 and Vibeke Strand11, 1Cedars-Sinai Medical Center, Los Angeles, CA, 2Internal Medicine, Vall De Hebron General Hospt, Barcelona, Spain, 3East Bay Rheumatology Research Institute, San Leandro, CA, 4UCSD School of Medicine, La Jolla, CA, 5Division of Rheumatology, Johns Hopkins University School of Medicine, Baltimore, MD, 62nd University Hospital in Bydgoszcz Medical College of Nicolaus Copernicus University, Bydgoszcz, Poland, 7Clinical Trials Unit Department of Rheumatology, The Karolinska Institute, Stockholm, Sweden, 8UCB Pharma, Raleigh, NC, 9UCB Pharma, Brussels, Belgium, 10Rheumatology Research Group (East Wing), School of Immunity and Infection, University of Birmingham, Birmingham, United Kingdom, 11Adjunct, Division of Immunology / Rheumatology, Stanford University, Palo Alto, CA

    Background/Purpose: The efficacy and safety of epratuzumab, a monoclonal antibody targeting CD22, has been evaluated in patients with moderate-to-severe systemic lupus erythematosus (SLE). A pooled…
  • Abstract Number: 1462 • 2013 ACR/ARHP Annual Meeting

    Unmasking The Tolerability Of Methotrexate In Patients With Rheumatoid and Psoriatic Arthritis: A Retrospective Review Of Discontinuation From a Large UK Cohort

    Andra Negoescu1, Elena Nikiphorou2, Anshuman P. Malaviya3, Andrew Badcock3, John D. Fitzpatrick3,4, Calum T. Goudie3,4 and Andrew J. Ostor3, 1Rheumatology, Rheumatology Research Unit, Addenbrooke's Hospital, Cambridge, United Kingdom, 2Rheumatology, Addenbrooke's Hospital, Cambridge, United Kingdom, 3Rheumatology Research Unit, Addenbrooke's Hospital, Cambridge, United Kingdom, 4University of Cambridge Medical School, Cambridge, United Kingdom

    Background/Purpose:   Due to its efficacy and perceived safety, methotrexate (MTX) has become the foundation disease-modifying drug for rheumatoid (RA) and psoriatic arthritis (PsA) however…
  • Abstract Number: 1038 • 2013 ACR/ARHP Annual Meeting

    Impact Of Biological Treatment On Overall Mortality and On Incidence Of Second Cancers In Arthritis Patients – A Follow-Up Study From The Danish Danbio Registry

    Lene Dreyer1, Lene Mellemkjær2, Inger Marie Jensen Hansen3 and Merete Lund Hetland4, 1Internal Medicine - Rheumatology Section, Copenhagen University Hospital at Gentofte, Copenhagen, Denmark, 2Danish Cancer Society Research Center, Copenhagen, Denmark, 3Department of Reumatology, OUH Svendborg Hospital, Svendborg, Denmark, 4Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, The Danish Rheumatologic Database (DANBIO), Glostrup Hospital., Copenhagen, Denmark

    Background/Purpose: It is largely unknown whether it is safe to treat arthritis patients with a previous malignancy with biologics. Only a few studies have address…
  • Abstract Number: 1041 • 2013 ACR/ARHP Annual Meeting

    Non-Differential Reporting Of Myocardial Infarction To a National Observational Drug Safety Study Using Linked Data: Linkage Of The British Society For Rheumatology Biologics Register For Rheumatoid Arthritis and The Myocardial Ischaemia National Audit Project

    Audrey SL Low1, Deborah P. Symmons2,3, Mark Lunt2, Louise K. Mercer2, Christopher Gale4,5, Kath Watson6, British Society for Rheumatology Biologics Registers (BSRBR) Control Centre Consortium1, William G. Dixon7, Kimme L. Hyrich8 and On behalf of the BSRBR9, 1Arthritis Research UK Epidemiology Unit, The University of Manchester, Manchester, United Kingdom, 2Arthritis Research UK Centre for Epidemiology, University of Manchester, Manchester, United Kingdom, 3Arthritis Research UK Epidemiology Unit, University of Manchester, Manchester, United Kingdom, 4Division of Epidemiology, Centre for Epidemiology and Biostatistics, University of Leeds, Leeds, United Kingdom, 5Department of Cardiology,York Teaching Hospital NHS Foundation Trust, York, United Kingdom, 6Arthritis Research UK Epidemiology Unit, Arthritis Research UK Epidemiology Unit, The University of Manchester, Manchester, United Kingdom, 7The University of Manchester, Manchester, United Kingdom, 8Arthritis Research UK Epidemiology Unit, Manchester Academic Health Sciences Centre, Institute of Inflammation and Repair, The University of Manchester, Manchester, United Kingdom, 9British Society for Rheumatology, London, United Kingdom

    Background/Purpose: The BSRBR-RA was established to compare the long term safety of anti tumour necrosis factor (TNFi) drugs with non-biologic drugs (nbDMARD) in subjects with…
  • Abstract Number: 1007 • 2013 ACR/ARHP Annual Meeting

    Dose Of Corticosteroid, Risk Of Adverse Events and Healthcare Resource Utilization In Systemic Lupus Erythematosus

    Wei-Shi Yeh1, Shih-Yin Chen2, Kathleen McCarty3, Qian Li2, Yuan-Chi Lee2 and Nathalie Franchimont3, 1Biogen Idec, Cambridge, MA, 2United BioSource Corporation, Lexington, MA, 3Biogen Idec Inc., Weston, MA

    Background/Purpose: Gluco-corticosteroids (GCs) are frequently used to treat autoimmune disease and their chronic use has long been known to cause adverse events (AEs). The purpose…
  • Abstract Number: 742 • 2013 ACR/ARHP Annual Meeting

    Safety Of Remission Induction With Rituximab Versus Cyclosphosphamide In Patients 65 and Older With Severe ANCA-Associated Vasculitis

    Eli Miloslavsky1, Ulrich Specks2, Peter A Merkel3, Philip Seo4, Robert F. Spiera5, Carol A. Langford6, Gary S. Hoffman7, Cees G.M. Kallenberg8, E. William St. Clair9, Nadia Tchao10, Linna Ding11, David Ikle12, Brett Jepson12, Paul Brunetta13 and John H. Stone14, 1Division of Rheumatology, Massachusetts General Hopsital, Boston, MA, 2Mayo Clinic, Rochester, MN, 3Division of Rheumatology, University of Pennsylvania and VA Medical Center, Philadelphia, PA, 4Rheumatology Division, Johns Hopkins Vasculitis Center, Johns Hopkins University, Baltimore, MD, 5Rheumatology, Hospital for Special Surgery, New York, NY, 6Center for Vasculitis Care and Research, Cleveland Clinic, Cleveland, OH, 7Center for Vasculitis Care and Research, Cleveland Clinic Foundation, Cleveland, OH, 8Rheumatology and Clinical Immunology, University Medical Center Groningen, Groningen, Netherlands, 9Medicine, Duke University Medical Center, Durham, NC, 10Immune Tolerance Network, Bethesda, MD, 11NIAID, Bethesda, MD, 12Rho, Chapel Hill, NC, 13Biotherapeutics, Genentech, So San Francisco, CA, 14Rheumatology, Massachusetts General Hospital, Boston, MA

    Background/Purpose: Retrospective studies have demonstrated that patients of advanced age with systemic vasculitis experience a higher mortality and adverse events than their younger counterparts. However,…
  • Abstract Number: 461 • 2013 ACR/ARHP Annual Meeting

    Higher TNFi Dosing Is Not Associated With More Serious Infectious Events (SIE), Elevated AST/ALT Or WBC<1.5 In The US Corrona Database

    Daniel Furst1, Mei Liu2, Jeffrey D. Greenberg3 and Joel M. Kremer4, 1Rheumatology, David Geffen School of Medicine, UCLA, Los Angeles, CA, 2CORRONA, Inc, Southborough, MA, 3NYU Hospital for Joint Diseases, New York, NY, 4Albany Medical College and The Center for Rheumatology, Albany, NY

    Higher TNFi Dosing Is Not Associated with More Serious Infectious Events (SIE), elevated AST/ALT or WBC 50 mg golim. q4wk for at least 3 months.Adverse…
  • Abstract Number: 260 • 2012 ACR/ARHP Annual Meeting

    Adjudication of Reported Serious Adverse Joint Events in the Tanezumab Clinical Development Program

    Marc C. Hochberg1, Steven B. Abramson2, David S. Hungerford3, Edward McCarthy4, Eric P. Vignon5, Michael D. Smith6, Leslie Tive7, Kenneth M. Verburg6 and Christine R. West8, 1Department of Medicine, University of Maryland, Baltimore, MD, 2Dept of Rheumatology/Medicine, NYU Langone Medical Center, New York, NY, 3Department of Ortho Surgery, Johns Hopkins University, Baltimore, MD, 4Pathology, The Johns Hopkins University School of Medicine, Baltimore, MD, 5Rheumatology 2B, Centre Hospitalier, Pierre Benite, France, 6Pfizer, Inc., Groton, CT, 7Arthritis, Pfizer Inc, New York, NY, 8Clinical Sciences, Pfizer, Williamston, MI

    Background/Purpose: Tanezumab (TNZ) has been shown to be efficacious for pain and function in patients with hip and knee osteoarthritis (OA). Unexpected reports of adverse…
  • Abstract Number: 2640 • 2012 ACR/ARHP Annual Meeting

    Methotrexate Adverse Events in a Cohort of US Veterans with Rheumatoid Arthritis

    Lisa A. Davis1, Brooke Ivan Polk2, Alyse D. Mann3, Gail S. Kerr4, Andreas M. Reimold5, Grant W. Cannon6, Ted R. Mikuls7 and Liron Caplan8, 1Div of Rheumatology, Univ of Colorado School of Med, Aurora, CO, 2University of Colorado Medical School, Aurora, CO, 3Research, Denver VA Medical Center, Denver, CO, 4Rheumatology, Washington DC VAMC, Georgetown and Howard University, Washington, DC, 5Rheumatology, Dallas VA and University of Texas Southwestern, Dallas, TX, 6Division of Rheumatology, George E. Wahlen VA Medical Center, Salt Lake City, UT, 7Omaha VA Medical Center and University of Nebraska Medical Center, Omaha, NE, 8Div of Rheumatology, Denver VA and University of Colorado School of Medicine, Aurora, CO

    Background/Purpose: Methotrexate (MTX) is the most commonly used medication for patients with rheumatoid arthritis (RA), however, the frequency of MTX adverse events (AE) has not…
  • Abstract Number: 2479 • 2012 ACR/ARHP Annual Meeting

    Rheumatoid Arthritis Does Not Increase Risk of Short Term Total Knee Replacement (TKR) Adverse Events (AE)

    Zachary J. LoVerde1, Lisa A. Mandl2, Beverly K. Johnson2, Mark P. Figgie3, Friedrich Boettner4 and Susan M. Goodman2, 1New York Medical College, Valhalla, NY, 2Rheumatology, Hospital for Special Surgery, New York, NY, 3Orthopedics, Hospital for Special Surgery, New York, NY, 4Orthopaedics, Hospital for Special Surgery, New York, NY

    Background/Purpose: TKR is commonly performed for rheumatoid arthritis (RA) and osteoarthritis (OA). Historically, RA patients were at higher risk of post-operative AEs. The purpose of…
  • Abstract Number: 2483 • 2012 ACR/ARHP Annual Meeting

    Folic Acid Pathway Single Neucelotide Polymorphisms Associated with Methotrexate-Related Significant Adverse Events

    Lisa A. Davis1, Brooke Ivan Polk2, Alyse D. Mann3, Roger K. Wolff4, Gail S. Kerr5, Andreas M. Reimold6, Grant W. Cannon7, Ted R. Mikuls8 and Liron Caplan9, 1Div of Rheumatology, Univ of Colorado School of Med, Aurora, CO, 2University of Colorado Medical School, Aurora, CO, 3Research, Denver VA Medical Center, Denver, CO, 4University of Utah, Salt Lake City, UT, 5Rheumatology, Washington DC VAMC, Georgetown and Howard University, Washington, DC, 6Rheumatology, Dallas VA and University of Texas Southwestern, Dallas, TX, 7Division of Rheumatology, George E. Wahlen VA Medical Center, Salt Lake City, UT, 8Omaha VA Medical Center and University of Nebraska Medical Center, Omaha, NE, 9Div of Rheumatology, Denver VA and University of Colorado School of Medicine, Aurora, CO

      Background/Purpose: Methotrexate (MTX) is the cornerstone medication in the treatment of rheumatoid arthritis (RA). While MTX has been associated with a number of adverse…
  • Abstract Number: 2169 • 2012 ACR/ARHP Annual Meeting

    Short to Medium Term Safety of Glucocorticoid Therapy in Rheumatoid Arthritis: A Systematic Review and Dose-Response Analysis of Randomized Controlled Trials

    Simon Tarp1, Daniel Furst2, John R. Kirwan3, Maarten Boers4, Henning Bliddal5, Thasia Woodworth6, Else Marie Bartels7, Bente Danneskiold-Samsoe5, Lars Erik Kristensen8, Steffen Thirstrup9, Mette Rasmussen9, Marian Kaldas10 and Robin Christensen1, 1Musculoskeletal Statistics Unit, The Parker Institute, Department of Rheumatology, Copenhagen University Hospital, Bispebjerg and Frederiksberg, Denmark, 2Div of Rheumatology, UCLA Medical School, Los Angeles, CA, 3Academic Rheumatology Unit, Bristol Royal Infirmary, Bristol, United Kingdom, 4Epidemiology & Biostatistics, VU University Medical Center, Amsterdam, Netherlands, 5Department of Rheumatology, The Parker Institute, Copenhagen University Hospital at Frederiksberg, Copenhagen F, Denmark, 6Leading Edge Clinical Research LLC, Florida, FL, 7Department of Rheumatology, The Parker Institute, Copenhagen University Hospital at Bispebjerg and Frederiksberg, Copenhagen F, Denmark, 8Rheumatology, Skåen University Hospital, Lund University, Lund, Sweden, 9Institute for Pharmacology and Pharmacotherapy, University of Copenhagen, Copenhagen, Denmark, 10David Geffen School of Medicine, University of California in Los Angeles, Los Angeles, CA

    Background/Purpose: Concerns regarding Adverse Effects (AEs) often dominate decisions on applying Glucocorticoid (GC) therapy. Evidence of AEs is mainly based on observational data without proper…
  • Abstract Number: 2158 • 2012 ACR/ARHP Annual Meeting

    Baseline Folate Related Biomarkers in Serum and erythrocytes Are Not Associated with Methotrexate Response and Adverse Events in Rheumatoid Arthritis

    Maurits C.F.J. De Rotte1, Saskia M.F. Pluijm2, Maja Bulatovic3, Johanna M.W. Hazes4 and Robert De Jonge1, 1Clinical Chemistry, Erasmus Medical Center, Rotterdam, Netherlands, 2Public Health, Erasmus Medical center, Rotterdam, Netherlands, 3Department of Paediatric Immunology, University Medical Centre Utrecht, Netherlands, 4Rheumatology, Erasmus MC, Rotterdam, Netherlands

    Background/Purpose: Methotrexate (MTX) is the most commonly used drug in rheumatoid arthritis (RA). 30% of patients fail to respond to the drug or suffer from…
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