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: 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: 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: 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: 2340 • 2018 ACR/ARHP Annual Meeting
The Impact of Chronic Glucocorticoid Use Amongst Patients with Rheumatoid Arthritis: A Qualitative Study
Jonathan Cheah^1,2, Sarah Young³, Susan M. Goodman^4,5, Catherine Hill^6,7, Susan Beard⁸, Pamela Richards⁹, Sarah Mackie¹⁰, Joanna Robson^11,12 and Iris Navarro-Millán^5,13, ¹Medicine, Hospital for Special Surgery, New York, NY, ²Medicine, Weill Cornell Medicine, New York, NY, ³Binghamton University, Binghamton, NY, ⁴Rheumatology, Weill Cornell Medicine, New York, NY, ⁵Hospital for Special Surgery, New York, NY, ⁶The Queen Elizabeth Hospital, Adelaide, Australia, ⁷Medicine, The University of Adelaide, Adelaide, Australia, ⁸Patient Research Partner, Adelaide, Australia, ⁹Patient Research Partner, Bristol, United Kingdom, ¹⁰NIHR-Leeds Musculoskeletal Biomedical Research Unit, University of Leeds, Leeds, United Kingdom, ¹¹Faculty of Health and Applied Science, University of the West of England, Bristol, United Kingdom, ¹²School of Clinical Sciences, University of Bristol, Bristol, United Kingdom, ¹³Weill Cornell Medicine, New York, NY
Background/Purpose: Glucocorticoids (GCs) have well documented adverse effects. However, the absolute risk and importance of these effects have not been well documented from the perspective…
Abstract Number: 1515 • 2018 ACR/ARHP Annual Meeting
Malignancy in Japanese Patients with Rheumatoid Arthritis Treated with Tofacitinib: Interim Analysis of All-Case Post-Marketing Surveillance
Naoto Tamura¹, Masataka Kuwana², Tatsuya Atsumi³, Syuji Takei⁴, Masayoshi Harigai⁵, Takao Fujii⁶, Hiroaki Matsuno⁷, Tsuneyo Mimori⁸, Shigeki Momohara⁹, Kazuhiko Yamamoto¹⁰, Yoshinari Takasaki¹¹, Kazuto Nomura¹², Yutaka Endo¹², Tomohiro Hirose¹², Yosuke Morishima¹², Naonobu Sugiyama¹², Noritoshi Yoshii¹² and Michiaki Takagi¹³, ¹Juntendo University, Tokyo, Japan, ²Nippon Medical School, Tokyo, Japan, ³Hokkaido University, Sapporo, Japan, ⁴Medical Center for Children, Kagoshima, Japan, ⁵Tokyo Women’s Medical University, Tokyo, Japan, ⁶Wakayama Medical University, Wakayama, Japan, ⁷Matsuno Clinic for Rheumatic Diseases, Toyama, Japan, ⁸Kyoto University, Kyoto, Japan, ⁹Hakkeikai Inc Medical Institution, Shizuoka, Japan, ¹⁰The University of Tokyo, Tokyo, Japan, ¹¹Juntendo Koshigaya Hospital, Juntendo University Faculty of Medicine, Saitama, Japan, ¹²Pfizer Japan Inc, Tokyo, Japan, ¹³Yamagata University Faculty of Medicine, Yamagata, Japan
Background/Purpose: Tofacitinib is an oral Janus kinase inhibitor for the treatment of RA. The efficacy and safety of tofacitinib have been demonstrated in patients (pts)…
Abstract Number: 2390 • 2018 ACR/ARHP Annual Meeting
Incidence of and Risk Factors for Adrenal Suppression Following Ultrasound-Guided Intra-Articular Corticosteroid Injection with Triamcinolone Acetonide in Juvenile Idiopathic Arthritis
Katherine K Ngo¹, Angelina Bernier¹, Melissa E Elder², Renee F Modica² and Akaluck Thatayatikom¹, ¹Pediatrics, University of Florida, Gainesville, FL, ²Department of Pediatrics, University of Florida, Gainesville, FL
Background/Purpose: Intra-articular corticosteroid injection (IACI) is routinely used in juvenile idiopathic arthritis (JIA) with oligoarticular disease and as adjunct therapy for other types of JIA.…

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