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 • 2020 Pediatric Rheumatology Symposium
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 • 2019 ACR/ARP Annual Meeting
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 • 2019 ACR/ARP Annual Meeting
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 • 2019 ACR/ARP Annual Meeting
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 • 2019 ACR/ARP Annual Meeting
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 • 2019 ACR/ARP Annual Meeting
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 • 2019 ACR/ARP Annual Meeting
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 • 2019 ACR/ARP Annual Meeting
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 • 2019 ACR/ARP Annual Meeting
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 • 2018 ACR/ARHP Annual Meeting
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 • 2018 ACR/ARHP Annual Meeting
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 • 2018 ACR/ARHP Annual Meeting
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 • 2018 ACR/ARHP Annual Meeting
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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