ACR Meeting Abstracts

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Abstracts tagged "drug safety"

  • Abstract Number: 961 • 2018 ACR/ARHP Annual Meeting

    The Association of Biologic Drug-Levels with Infection Risk: Results from the British Society for Rheumatology Biologics Register for Rheumatoid Arthritis

    Meghna Jani1, William G Dixon1, Mark Lunt1, Diederik De Cock1, John Isaacs2, Ann Morgan3, Kath Watson1, Anthony G. Wilson4, Anne Barton5,6 and Kimme L. Hyrich1,5, 1Arthritis Research UK Centre for Epidemiology, The University of Manchester, Manchester, United Kingdom, 2Institute of Cellular Medicine, Newcastle University, Newcastle upon Tyne, United Kingdom, 3Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds and NIHR Leeds Musculoskeletal Biomedical Research Unit, Leeds Teaching Hospitals NHS Trust, Leeds, Great Britain, 4UCD School of Medicine and Medical Science, Conway Institute, University College Dublin, Dublin, Ireland, 5National Institute of Health Research Manchester Biomedical Research Centre, Manchester University NHS Foundation Trust, Manchester Academic Health Science Centre, Manchester, United Kingdom, 6Arthritis Research UK Centre for Genetics and Genomics, Centre for Musculoskeletal Research, Manchester Academic Health Science Centre, The University Of Manchester, Manchester, United Kingdom

      Background/Purpose: High dose tumour necrosis factor inhibitor (TNFi) drugs are associated with an increased serious infection (SI) risk[1]. It is feasible that high biologic…
  • Abstract Number: 1398 • 2018 ACR/ARHP Annual Meeting

    Inflammatory Arthritis DMARD Adverse Effects Are Pervasive and Can Greatly Impact Quality of Life and Work and Social Roles: Initial Results from the Omeract Safety Working Group

    Kathleen M. Andersen1, Ayano Kelly2, Anne Lyddiatt3, Clifton O. Bingham III4, Vivian P. Bykerk5, Marita Cross6, Adena Batterman7, Joan Westreich8, Lyn March9, Michelle Jones10, Beverly Shea11, Peter Tugwell12, Peter Brooks13, Lee S. Simon14, Robin Christensen15 and Susan J. Bartlett16, 1Department of Family Medicine, McGill University, Montreal, QC, Canada, 2Centre for Kidney Research, The Children's Hospital at Westmead, Sydney, Australia, 3Musculoskeletal Group, Cochrane Collaboration, Hamilton, ON, Canada, 4Rheumatology, Johns Hopkins University School of Medicine, Baltimore, MD, 5Deptartment of Rheumatology, Hospital for Special Surgery, New York, NY, 6Institute of Bone and Joint Research–Kolling Institute, University of Sydney, Sydney, Australia, 7Social Work Programs, Hospital for Special Surgery, New York, NY, 8Department of Social Work Programs, Hospital for Special Surgery, New York, NY, 9Department of Rheumatology, Northern Clinical School, Institute of Bone and Joint Research, Kolling Institute, University of Sydney & Department of Rheumatology, Royal North Shore Hospital, St Leonards, Sydney, Australia, 10Johns Hopkins University School of Medicine, Baltimore, MD, 11University of Ottawa, Ottawa, ON, Canada, 12Center For Global Health, Institute of Population Hlth, Ottawa, ON, Canada, 13The University of Melbourne, Victoria, Australia, 14SDG LLC Consulting, West Newton, MA, 15Musculoskeletal Statistics Unit, The Parker Institute, Bispebjerg and Frederiksberg, Denmark, 16Department of Medicine, Division of ClinEpi, Rheumatology, Respirology, McGill University, Montreal, QC, Canada

    Background/Purpose: There is suboptimal reporting of adverse events (AE) in trials. The OMERACT Safety Working Group is developing a patient-centered AE collection and reporting approach…
  • Abstract Number: 1542 • 2018 ACR/ARHP Annual Meeting

    Real-World Data from a Post-Approval Safety Surveillance Study of Tofacitinib Vs Biologic Dmards and Conventional Synthetic Dmards: Five-Year Results from a US-Based Rheumatoid Arthritis Registry

    Joel Kremer1, Laura C. Cappelli2, Carol J. Etzel3, Jeffrey Greenberg3, Jamie Geier4, Ann Madsen4, Connie Chen4, Alina Onofrei3, Christine J Barr3, Dimitrios A. Pappas3, Kimberly J Dandreo3, Andrea Shapiro5, Carol A Connell6 and Arthur Kavanaugh7, 1Albany Medical College and the Center for Rheumatology, Albany, NY, 2Johns Hopkins University, Baltimore, MD, 3Corrona LLC, Waltham, MA, 4Pfizer Inc, New York, NY, 5Pfizer Inc, Peapack, NJ, 6Pfizer Inc, Groton, CT, 7University of California, San Diego School of Medicine, La Jolla, San Diego, CA

    Background/Purpose: Tofacitinib is an oral Janus kinase inhibitor for the treatment of RA. A prospective observational 5-year study, embedded within the US Corrona RA registry,…
  • Abstract Number: 1853 • 2018 ACR/ARHP Annual Meeting

    Paternal Use of Methotrexate (MTX) and Congenital Malformations – a Systematic Review and Meta-Analysis

    Thomas Bo Jensen1, Mikkel Bring Christensen1,2 and Jon Trærup Andersen1,2, 1Department of Clinical Pharmacology, Copenhagen University Hospital Bispebjerg, Copenhagen, Denmark, 2Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark

    Background/Purpose: In rheumatology, fertile men and women are commonly treated with methotrexate (MTX). Maternal preconceptional MTX exposure is teratogenic, but less is known about paternal…
  • Abstract Number: 2253 • 2018 ACR/ARHP Annual Meeting

    Cardiovascular Disease, Other Purported Risk Factors, and Allopurinol-Associated Severe Cutaneous Adverse Reactions: A General Population-Based Cohort Study

    Na Lu1, Chio Yokose2, Hui Xie1,3, Gloria Li1, Sharan K. Rai4,5, Seoyoung C. Kim6 and Hyon K. Choi2, 1Arthritis Research Canada, Richmond, BC, Canada, 2Division of Rheumatology, Allergy, and Immunology, Massachusetts General Hospital, Boston, MA, 3Faculty of Health Sciences, Simon Fraser University, Burnaby, BC, Canada, 4Division of Rheumatology, Allergy and Immunology, Massachusetts General Hospital, Boston, MA, 5Graduate School of Arts and Sciences, Harvard University, Cambridge, MA, 6Brigham and Women’s Hospital, Harvard Medical School, Boston, MA

    Background/Purpose: A recent US Medicaid study found that in addition to certain races (Asians and Blacks), older age, female sex, chronic kidney disease (CKD), and…
  • Abstract Number: 2391 • 2018 ACR/ARHP Annual Meeting

    Methotrexate Polyglutamates As an Evaluation Tool for Appropriate Dosage of Oral Methotrexate Administration in Pediatric Patients

    Nami Okamoto1, Kosuke Shabana2, Yasuo Nakagishi3, Kenichi Nishimura4, Mao Mizuta5, Yuka Okura6, Masaki Shimizu5, Hiroyuki Wakiguchi7, Junko Yasumura8 and Masaaki Mori9, 1Pediatrics, Osaka Medical College, Takatsuki, Japan, 2Department of Pediatrics, Osaka Medical College, Takatsuki, Japan, 3Department of Pediatric Rheumatology, Hyogo Prefectural Kobe Children’s Hospital, Kobe, Japan, 4Department of Pediatrics, Yokohama City University Graduate School of Medicine, Yokohama, Japan, 5Department of Pediatrics, Graduate School of Medical Sciences, Kanazawa University, Kanazawa, Japan, 6Department of Pediatrics, KKR Sapporo Medical Center, Sapporo, Japan, 7Department of Pediatrics, Yamaguchi University Graduate School of Medicine, Ube, Japan, 8Department of Pediatrics, Hiroshima University Graduate School of Biomedical & Health Sciences, Hiroshima, Japan, 9Department of Lifetime Clinical Immunology, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University, Tokyo, Japan

    Background/Purpose: Since MTX metabolism varies depending on age and dosage, we need to know optimal MTX administration method in children. We performed multi-center prospective study…
  • Abstract Number: 2834 • 2018 ACR/ARHP Annual Meeting

    The Presence of Anti-Rituximab Antibodies Predicts Infusion-Related Reactions in Patients with Systemic Lupus Erythematosus

    Chris Wincup1, Madhvi Menon1, Edward Smith2, David A. Isenberg1, Elizabeth Jury3 and Claudia Mauri4, 1University College London, London, United Kingdom, 2Centre for Rheumatology Research, University College London, London, United Kingdom, 3Division of Medicine, Centre for Rheumatology Research, University College London, London, United Kingdom, 4Division of Medicine, Centre for Rheumatology Research, University College London, University College London, London, United Kingdom

    Background/Purpose: Rituximab is a genetically engineered chimeric anti-CD20 monoclonal antibody that is commonly used in the treatment of severe and refractory SLE. Although generally well…
  • Abstract Number: 215 • 2017 ACR/ARHP Annual Meeting

    Clinical Pharmacist As Part of the Interprofessional Team Improves Quality of Care in Patients with Rheumatic Disease

    Jessica Farrell1, Lee S. Shapiro1 and Mitchell Miller2, 1The Center for Rheumatology, Albany, NY, 2Albany College of Pharmacy and Health Sciences, Albany, NY

    Background/Purpose: Successful multidisciplinary models exist for the management of chronic diseases such as diabetes, cardiovascular disease, infectious diseases, kidney disease and psychiatric illnesses. A multidisciplinary…
  • Abstract Number: 841 • 2017 ACR/ARHP Annual Meeting

    Optimal Regimens of Sulfamethoxazole-Trimethoprim for Chemoprophylaxis of Pneumocystis Pneumonia in Patients with Systemic Rheumatic Diseases: 52-Week Follow-up of a Non-Blinded, Randomized Controlled Trial

    Masayoshi Harigai1,2, Masako Utsunomiya2,3,4, Hiroaki Dobashi5, Toshio Odani6,7, Kazuyoshi Saito8,9, Naoto Yokogawa10, Kenji Nagasaka11,12, Kenchi Takenaka3,11, Makoto Soejima11,13, Takahiko Sugihara14, Hiroyuki Hagiyama15, Shinya Hirata16, Kazuo Matsui17,18, Yoshinori Nonomura19, Masahiro Kondo20, Fumihito Suzuki13,21, Makoto Tomita22, Mari Kihara23, Waka Yokoyama3, Fumio Hirano24, Hayato Yamazaki3, Ryoko Sakai2,25, Toshihiro Nanki2,26, Ryuji Koike2,3, Hitoshi Kohsaka3 and Nobuyuki Miyasaka3, 1Division of Epidemiology and Pharmacoepidemiology of Rheumatic Diseases, Institute of Rheumatology, Tokyo Women's Medical University, Tokyo, Japan, 2Department of Pharmacovigilance, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University, Tokyo, Japan, 3Department of Rheumatology, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University, Tokyo, Japan, 4Department of Rheumatology, Musashino Red Cross Hospital, Tokyo, Japan, 5Internal Medicine Division of Hematology, Rheumatology, and Respiratory Medicine, Kagawa University, Kagawa, Japan, 6Third Department of Internal Medicine, Obihiro-Kosei General Hospital, Hokkaido, Japan, 7Molecular Physiology and Therapeutics Branch/Adeno-Associated Virus Biology Section, National Institute of Dental and Craniofacial Research (NIDCR)/ National Institutes of Health (NIH), Bethesda, MD, 8Tobata General Hospital, Fukuoka, Japan, 9The First Department of Internal Medicine, University of Occupational and Environmental Health, Kitakyushu, Japan, 10Department of Rheumatic Diseases, Tokyo Metropolitan Tama Medical Center, Tokyo, Japan, 11Department of Rheumatology, Ome Municipal General Hospital, Tokyo, Japan, 12Department of Pharmacovigilance, Graduate School of Medical and Dental Sciences,, Tokyo Medical and Dental University, Tokyo, Japan, 13Department of Rheumatology, Soka Municipal Hospital, Saitama, Japan, 14Department of Medicine and Rheumatology, Tokyo Metropolitan Geriatric Hospital, Tokyo, Japan, 15Department of Rheumatology, Yokohama City Minato Red Cross Hospital, Kanagawa, Japan, 16Department of Hematology, Rheumatology, and Infectious Disease, Kumamoto University, Kumamoto, Japan, 17Department of Rheumatology, Kameda Medical Center, Chiba, Japan, 18Department of Internal Medicine, Takikawa Municipal Hospital, Hokkaido, Japan, 19Department of Rheumatology, Tokyo Kyosai Hospital, Tokyo, Japan, 20Department of Rheumatology, Faculty of Medicine, Shimane University, Shimane, Japan, 21Department of Rheumatology, JA Toride Medical Center, Ibaraki, Japan, 22Clinical Research Center, Tokyo Medical and Dental University, Tokyo, Japan, 23Department of Rheumatology, Tokyo Medical and Dental University, Tokyo, Japan, 24Departments of Rheumatology, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University, Tokyo, Japan, 25Division of Epidemiology and Pharmacoepidemiology of Rheumatic Diseases, Institute of Rheumatology, Tokyo Women’s Medical University, Tokyo, Japan, 26Division of Rheumatology, Department of Internal Medicine, Toho University School of Medicine, Tokyo, Japan

    Background/Purpose: Sulfamethoxazole-trimethoprim (SMX/TMP) is a standard drug for the prophylaxis of Pneumocystis pneumonia (PCP), but is sometimes discontinued due to adverse events (AEs). We have…
  • Abstract Number: 1036 • 2017 ACR/ARHP Annual Meeting

    Blood Glucose Changes Surrounding Initiation of Tumor-Necrosis Factor Inhibitors and Conventional Disease-Modifying Anti-Rheumatic Drugs in Veterans with Rheumatoid Arthritis

    Patrick R. Wood1, Evan Manning2, Joshua Baker3, Grant Cannon4, Lisa Davis5, Bryant R. England6, Ted R. Mikuls7 and Liron Caplan8, 1Rheumatology, University of Colorado School of Medicine, Aurora, CO, 2University of Colorado School of Medicine, Aurora, CO, 3Rheumatology, University of Pennsylvania, Philadelphia, PA, 4Salt Lake City VA Medical Center and University of Utah, Salt Lake City, UT, 5Div of Rheumatology, Denver Health, Denver, CO, 6Division of Rheumatology & Immunology, Department of Internal Medicine, Nebraska-Western IA VA Health Care System & University of Nebraska Medical Center, Omaha, NE, 7Internal Medicine, Division of Rheumatology, University of Nebraska Medical Center, Omaha, NE, 8Division of Rheumatology, University of Colorado School of Medicine, Aurora, CO

    Background/Purpose: There is evidence linking activation of the innate immune system and insulin resistance.  Perturbations in glucose homeostasis upon initiation of tumor-necrosis factor inhibitors (TNFis)…
  • Abstract Number: 1316 • 2017 ACR/ARHP Annual Meeting

    Risk of Preterm Delivery Associated with Perinatal Exposure to Dmards in Women with Inflammatory Arthritis: A Population-Based Cohort Study

    Nicole W. Tsao1,2, Eric C. Sayre2, Mohsen Sadatsafavi1, J. Antonio Avina-Zubieta2,3, Stephanie Ensworth4 and Mary A. De Vera1,2, 1Faculty of Pharmaceutical Sciences, University of British Columbia, Vancouver, BC, Canada, 2Arthritis Research Canada, Richmond, BC, Canada, 3Division of Rheumatology, Department of Medicine, University of British Columbia, Vancouver, BC, Canada, 4University of British Columbia, Vancouver, BC, Canada

    Background/Purpose: Given the limited data on impacts of perinatal medication use, our objective was to investigate the association between conventional synthetic DMARD (csDMARD) use preconception…
  • Abstract Number: 2222 • 2017 ACR/ARHP Annual Meeting

    Comparative Risk of Respiratory Depression in Patients Treated with Opioids for Non-Malignant Pain

    Meghna Jani, Kamilla Kopec-Harding, Mark Lunt and William G Dixon, Arthritis Research UK Centre for Epidemiology, The University of Manchester, Manchester, United Kingdom

    Background/Purpose: Opioid use for non-cancer pain has increased considerably over the last 30 years. The U.S. Food and Drug Administration announced several boxed warnings in…
  • Abstract Number: 2472 • 2017 ACR/ARHP Annual Meeting

    Integrated Phase 3 Safety Results of Sirukumab, an Anti–IL-6 Cytokine Monoclonal Antibody, in Patients with Active Rheumatoid Arthritis

    Daniel Aletaha1, Carter Thorne2, Michael Schiff3, Masayoshi Harigai4, Prasheen Agarwal5, Ravi Rao6, Christopher Cohen7, Ben Cheng5, Kurt Brown7 and Benjamin Hsu5, 1Department of Medicine III, Division of Rheumatology, Medical University of Vienna, Vienna, Austria, 2University of Toronto, Newmarket, ON, Canada, 3University of Colorado School of Medicine, Aurora, CO, 4Division of Epidemiology and Pharmacoepidemiology of Rheumatic Diseases, Institute of Rheumatology, Tokyo Women's Medical University, Tokyo, Japan, 5Janssen Research & Development, LLC, Spring House, PA, 6GlaxoSmithKline, Stevenage, Hertfordshire, United Kingdom, 7GlaxoSmithKline, Collegeville, PA

    Background/Purpose: Sirukumab (SIR), a human monoclonal antibody that selectively binds to the IL-6 cytokine with high affinity, is in development for rheumatoid arthritis (RA) in…
  • Abstract Number: 1057 • 2016 ACR/ARHP Annual Meeting

    Effect of Quantitative Information Concerning Medication Side-Effects on Risk Perception

    Susan J. Blalock1 and Matthew Dixon2, 1Eshelman School of Pharmacy, UNC at Chapel Hill, Chapel Hill, NC, 2Eshelman School of Pharmacy, University of North Carolina at Chapel Hill, Chapel Hill, NC, Namibia

    Background/Purpose: The Food and Drug Administration (FDA) requires that patients prescribed a bisphosphonate to treat osteoporosis receive an FDA-approved Medication Guide that warns of the…
  • Abstract Number: 2162 • 2016 ACR/ARHP Annual Meeting

    Frequent Discussion of Insomnia and Weight Gain with Glucocorticoid Therapy: An Analysis of Twitter Posts

    Rikesh Patel1, Nabarun Dasgupta2, Maksim Belousov3, Meghna Jani4, Carly Winokur2, Goran Nenadic3 and William G Dixon1,5, 1Centre for Musculoskeletal Research, The University of Manchester, Manchester, United Kingdom, 2Epidemico Inc., Boston, MA, 3School of Computer Sciences, The University of Manchester, Manchester, United Kingdom, 4Centre for Musculoskeletal Research, University of Manchester, Manchester, United Kingdom, 5Manchester Academic Health Sciences Centre, Health e-Research Centre, Farr Institute for Health Informatics Research, The University of Manchester, Manchester, United Kingdom

    Background/Purpose: Glucocorticoid (GC) therapy is used widely in patients with inflammatory diseases. However their effectiveness is offset by a range of potential harms. Clinicians and…
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