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Abstracts tagged "Adverse events"

  • Abstract Number: 0104 • ACR Convergence 2021

    Adverse Events of First SARS-CoV-2 Vaccinations Are Comparable for Patients with Autoimmune Diseases and the General Population

    Laura Boekel1, Laura Kummer2, Koos van Dam2, Femke Hooijberg1, Zoé van Kempen2, Erik Vogelzang2, Luuk Wieske2, Filip Eftimov2, Ronald van Vollenhoven3, Taco Kuijpers2, Marieke van Ham4, Sander Tas5, Joep Killestein2, Maarten Boers6, Mike Nurmohamed7, Theo Rispens4 and Gertjan Wolbink1, 1Reade, Amsterdam, Netherlands, 2Amsterdam UMC, Amsterdam, Netherlands, 3Department of Rheumatology and Clinical Immunology, Amsterdam University Medical Center, Amsterdam Rheumatology Center, Amsterdam, Netherlands, 4Sanquin, Amsterdam, Netherlands, 5Amsterdam UMC, locatie AMC, Utrecht, Netherlands, 6Amsterdam UMC, Vrije Universiteit, Amsterdam, Netherlands, 7Reade; Amsterdam Rheumatology & Immunology Center, Amsterdam, Netherlands

    Background/Purpose: Clinical trials on efficacy and safety of SARS-CoV-2 vaccines did not include patients with autoimmune diseases. We previously demonstrated that concerns of adverse events…
  • Abstract Number: 1444 • ACR Convergence 2021

    Baseline Factors Associated with the Development of Nausea and Alopecia over One Year in Patients Starting Methotrexate for Rheumatoid Arthritis

    Ahmad Sherbini1, James Gwinnutt1, Kimme Hyrich1 and Suzanne Verstappen2, 1University of Manchester, Manchester, United Kingdom, 2School of Social Sciences, The University of Manchester, Manchester, United Kingdom

    Background/Purpose: Methotrexate (MTX) is the first-line treatment in the management of patients with rheumatoid arthritis (RA) due to its good efficacy. However, certain adverse events,…
  • Abstract Number: 008 • Pediatric Rheumatology Symposium 2020

    Incidence and Risk Factors of Hypogammaglobulinemia and Infectious Complications Associated with Rituximab Use in Pediatric Rheumatic Diseases

    Mei-Sing Ong1, Deborah Rothman 2 and Marc Natter 3, 1Harvard Medical School & Harvard Pilgrim Healthcare Institute, Boston, 2Massachusetts General Hospital, Springfield, 3Boston Children's Hospital, Boston

    Background/Purpose: B-cell depletion therapy has increasingly been used for the treatment of childhood-onset rheumatic diseases. Previous studies investigating whether rituximab results in increased infections have…
  • Abstract Number: 1810 • ACR/ARP Annual Meeting 2019

    Rheumatic Toxicities Associated with Immune Checkpoint Inhibitors: An Observational, Retrospective, Pharmacovigilance Study

    Céline Anquetil1, Olivier Benveniste 1, Javid ‎ Moslehi 2, Douglas Johnson 2, Bénédicte lebrun-vignes 1, Olivier Lambotte 3, Joe-Elie Selam 4, Jean-Philippe Spano 5 and Yves Allenbach 1, 1Sorbonne Université, Paris, France, 2Vanderbilt, Nashville, 3APHP Médecine Interne/Immunologie Clinique, Hôpital Bicêtre, Paris, France. Université Paris Sud 11 – INSERM U1184 - CEA, Immunology of Viral Infections and Autoimmune Diseases, IDMIT Department, IBFJ, Fontenay-aux-Roses & Le Kremlin-Bicêtre, France., Paris, France, 4Sorbonne université, Paris, 5Sorbonne Université, Paris, French Guiana

    Background/Purpose: Monoclonal antibodies targeting co-inhibitory immune checkpoints (PD-1/PDL1 axis or CTLA-4) showed unprecedented clinical activity in several types of cancer by restoring antitumor immune responses.…
  • Abstract Number: 2139 • ACR/ARP Annual Meeting 2019

    Rheumatic Immune-Related Adverse Events Associated with Treatment with Immune Checkpoint Inhibitors: A Multicenter Study of 38 Cases

    Sebastian Rodriguez-Garcia1, David Lobo 2, Fabiola Ojeda 3, Raul Castellanos-Moreira 4, Ana Laiz 2, Roberto Gumucio 4, Cesar Diaz-Torné 2, Virginia Ruiz-Esquide 5, Milena Millan 2, Ivan Castellvi 6, Patricia Moya Alvarado 7, Berta Magallares 2, Carolina Perez 3, Hector Corominas 8 and Jose Gomez-Puerta 9, 1Rheumatology Department. Hospital Clínic Barcelona, Barcelona, Spain, 2Rheumatology Department. Hospital Sant Pau, Barcelona, Catalonia, Spain, 3Rheumatology Department. Hospital del Mar, Barcelona, Catalonia, Spain, 4Rheumatology Department. Hospital Clínic Barcelona, Barcelona, Catalonia, Spain, 5Department of Rheumatology, Hospital Clínic, Barcelona, Barcelona, Catalonia, Spain, 6Hospital de la Santa Creu i Sant Pau, Barcelona, Spain, 7Hospital de la Santa Creu i Sant Pau, Barcelona, Catalonia, Spain, 8Rheumatology Department, Hospital Sant Pau, Barcelona, Catalonia, Spain, 9Department of Rheumatology, Hospital Clínic, Barcelona, Barcelona, Spain

    Background/Purpose: Immune checkpoint inhibitors (ICI) against CTLA-4 or PD- 1/PD-L1 and more recently TIM3,  have demonstrated efficacy in improving the survival of patients with diverse…
  • Abstract Number: 2585 • ACR/ARP Annual Meeting 2019

    A Comparison of Risk of Ovarian Failure Following Intravenous Cyclophosphamide Therapy in Juvenile versus Adult Systemic Lupus Erythematosus

    shefali sharma1, Hemanth Chinthala 2, siddharth Jain 2, Arghya Chattopadhyay 2, Pooja Bahl 2, Varun Dhir 3, naresh Sachdeva 2 and Surjit Singh 4, 1Dr., Chandigarh, Chandigarh, India, 2Post Graduate Institute of Medical Education and Research, chandigarh, Chandigarh, India, 3Post Graduate Institute of Medical Education and Research, Chandigarh, India, 4Allergy Immunology Unit, Department pf Pediatrics, Advanced Pediatrics Centre, Postgraduate Institute of Medical Education and Research, Chandigarh, India

    Background/Purpose: Premature ovarian failure is a dreaded complication of cyclophosphamide (CYC).  It is related to age of initiation of therapy and the cumulative dose. This…
  • Abstract Number: 1116 • ACR/ARP Annual Meeting 2019

    Non-medical Switching from Reference to Biosimilar Etanercept – No Evidence for Nocebo Effect – a Retrospective Analysis of Real-life Data

    Uta Kiltz1, Styliani Tsiami 1, Xenofon Baraliakos 2 and Jürgen Braun 3, 1Rheumazentrum Ruhrgebiet/Ruhr University Bochum, Herne, Germany, Herne, Germany, 2Rheumazentrum Ruhrgebiet-Ruhr-University Bochum, Herne, Germany, Herne, Germany, 3Rheumazentrum Ruhrgebiet/Ruhr University, Herne, Germany

    Background/Purpose: Real-world data about switching patients from originator product to a biosimilars are important to assess and to document the outcome of switches in clinical…
  • Abstract Number: 1194 • ACR/ARP Annual Meeting 2019

    Can an MDHAQ (Multidimensional Health Assessment Questionnaire) 60-Symptom Checklist to Monitor Early Medication Outcomes (MDHAQ/MEMO60) Detect Adverse Events of High-Risk Medications?

    Sarah Abu Mehsen 1, Isabel Castrejon 1 and Theodore Pincus2, 1Rush University Medical Center, Chicago, IL, 2Division of Rheumatology, Rush University Medical Center, Chicago, IL

    Background/Purpose: Adverse events of medications have been reported to account for 5% of hospital admissions in the US, and as many as 10% in the…
  • Abstract Number: 1329 • ACR/ARP Annual Meeting 2019

    Pooled Safety Analyses from Phase 3 Studies of Filgotinib in Patients with Rheumatoid Arthritis

    Kevin Winthrop1, Mark Genovese 2, Bernard Combe 3, Yoshiya Tanaka 4, Alan Kivitz 5, Franziska Matzkies 6, Beatrix Bartok 6, Lei Ye 6, Ying Guo 6, Chantal Tasset 7, John Sundy 6, Edward Keystone 8, Rene Westhovens 9, William F.C. Rigby 10 and Gerd Burmester 11, 1Oregon Health and Science University, Portland, OR, 2Stanford University, Stanford, CA, 3CHU Montpellier, Montpellier University, Montpellier, France, 4University of Occupational and Environmental Health Japan, Kitakyushu, Japan, 5Altoona Center for Clinical Research, Duncansville, PA, 6Gilead Sciences, Inc., Foster City, CA, 7Galapagos NV, Mechelen, Belgium, 8Mount Sinai Hospital and University of Toronto, Toronto, Canada, 9University Hospitals, Leuven, Belgium, 10Dartmouth College, Lebanon, NH, 11Charité—University Medicine Berlin, Berlin, Germany

    Background/Purpose: Filgotinib (FIL) is an orally administered, selective inhibitor of Janus Kinase 1 (JAK1) that is under development for the treatment of RA and other…
  • Abstract Number: 1436 • ACR/ARP Annual Meeting 2019

    Analysis of Adverse Events of Methotrexate (MTX), bDMARDs and Tofacitinib (TOFA) Reported to Pharmaceuticals and Medical Devices Agency (PMDA), Japan

    Naonori Tsuda1, Shigeko Inokuma 2, Kenichi Hiraga 3, Yoshinori Masui 3 and Toshikazu Kano 3, 1Kohondai Hospital, National Center for Global health and Medicine, Ichikawa, Chiba, Japan, 2Chiba Central Medical Center, Ichikawa, Chiba, Japan, 3Kohnodai Hospital, National Center for Global health and Medicine, Ichikawa, Chiba, Japan

    Background/Purpose: Among DMARDs (disease modifying anti-rheumatic drugs), methotrexate (MTX), bDMARDs (biologic DMARDs) and JAK (Janus kinase) inhibitors are the major. Many adverse events of these…
  • Abstract Number: 1809 • ACR/ARP Annual Meeting 2019

    A Quarter of Patients Treated with Checkpoint Inhibitors Develop Immune-Related Adverse Events: A University Center Experience

    Celine Zhou 1, Whitney Elg-Salsman1, Sonam Kiwalkar 2, Nishad Sathe 1, Marcia Friedman 1 and Atul Deodhar 2, 1Oregon Health and Science University, Portland, OR, 2Oregon Health & Science University, Portland, OR

    Background/Purpose: Immune checkpoint inhibitors (ICIs) are increasingly becoming the mainstay of management of advanced malignancies, but can result in immune related adverse events (irAEs) affecting…
  • Abstract Number: 1537 • ACR/ARHP Annual Meeting 2018

    Frequency and Duration of Early Non-Serious Adverse Events in Rheumatoid Arthritis Patients Treated with Tofacitinib 5 Mg Twice Daily As Monotherapy and Combination Therapy

    Ara Dikranian1, Jürgen Wollenhaupt2, Valderilio F Azevedo3, Louis Bessette4, David Gold5, Jose L Rivas6, Harry Shi7, Lisy Wang8, John Woolcott7, Andrea Shapiro9 and Peter Nash10, 1Cabrillo Center for Rheumatic Disease, San Diego, CA, 2Schön Klinik Hamburg-Eilbek Teaching Hospital of the University of Hamburg, Hamburg, Germany, 3Universidade Federal do Paraná, Curitiba, Brazil, 4Laval University, Kirkland, QC, Canada, 5Pfizer Canada, Montreal, QC, Canada, 6Pfizer SLU, Madrid, Spain, 7Pfizer Inc, Collegeville, PA, 8Pfizer Inc, Groton, CT, 9Pfizer Inc, Peapack, NJ, 10University of Queensland, Brisbane, Australia

    Background/Purpose: Tolerability remains ill-defined in clinical trials and most commonly refers to non-serious adverse events (AEs) that may impact patient (pt) satisfaction and adherence to…
  • Abstract Number: 2585 • ACR/ARHP Annual Meeting 2018

    Secukinumab Immunogenicity in Patients with Psoriatic Arthritis and Ankylosing Spondylitis during a 52-Week Treatment Period

    Atul A. Deodhar1, Dafna D Gladman2, Iain B. McInnes3, Vibeke Strand4, Mengyuan Ren5, Sebastian Spindeldreher6, Luminita Pricop7, Brian Porter7, Jorge Safi7, Abhijit Shete8 and Gerard Bruin6, 1Oregon Health & Science University, Portland, OR, 2Krembil Research Institute, Toronto Western Hospital, Toronto, ON, Canada, 3Institute of Infection, Immunity and Inflammation, University of Glasgow, Glasgow, United Kingdom, 4Division of Immunology/Rheumatology, Stanford University, Palo Alto, CA, 5Novartis Pharmaceuticals, Shanghai, China, 6Novartis Institutes for BioMedical Research, Basel, Switzerland, 7Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA, East Hanover, NJ, 8Novartis Pharma AG, Basel, Switzerland, Basel, Switzerland

    Background/Purpose: Secukinumab, a fully human monoclonal IgG1 antibody (mAb) that selectively targets IL-17A, is efficacious for the treatment of psoriasis, psoriatic arthritis (PsA) and ankylosing…
  • Abstract Number: 1539 • ACR/ARHP Annual Meeting 2018

    Safety of Methotrexate and Leflunomide Combination Therapy in the Treatment of Rheumatoid Arthritis

    María Badilla1, Nicia Moldenhauer2, Diego Neira3, Luis Muñoz4 and Oscar Neira1, 1Rheumatology Section., Hospital del Salvador, Universidad de Chile., Santiago, Chile, 2Rheumatology Section, Hospital del Salvador, Universidad de Chile, Santiago, Chile, 3Internal Medicine Departament, Hospital del Salvador, Universidad de Chile, Santiago, Chile, 4Pharmacy Department, Hospital del Salvador, Santiago, Chile

    Background/Purpose: Best treatment of Rheumatoid Arthritis (RA) requires to begin early, with a tight control, including nonsteroidal anti-inflammatory drugs (NSAIDs), steroids, disease-modifying antirheumatic drugs (DMARDs)…
  • Abstract Number: 2604 • ACR/ARHP Annual Meeting 2018

    Incidence of Serious Gastrointestinal Events and Inflammatory Bowel Disease Among Tildrakizumab-Treated Patients with Moderate to Severe Plaque Psoriasis: Data from 3 Large Randomized Clinical Trials

    Melinda Gooderham1, Boni E. Elewski2, David M. Pariser3, Howard Sofen4, Alan M Mendelsohn5, Nicole Cichanowitz6 and Qing Li6, 1Probity Medical Research, and Skin Center for Dermatololgy, Waterloo, and Peterborough, ON, Canada, 2University of Alabama at Birmingham, Birmingham, AL, 3Eastern Virginia Medical School and Virginia Clinical Research, Inc., Norfolk, VA, 4Ronald Reagan UCLA Medical Center, Department of Medicine (Dermatology) UCLA, Los Angeles, CA, 5Sun Pharmaceutical Industries, Inc., Princeton, NJ, 6Merck & Co., Inc., Kenilworth, NJ

    Background/Purpose: Tildrakizumab (TIL), a high-affinity, humanized, immunoglobulin G1κ, anti–interleukin-23p19 monoclonal antibody, has demonstrated efficacy in the treatment of chronic plaque psoriasis.1,2 Here, we evaluate the…
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