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: 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: 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: 960 • 2018 ACR/ARHP Annual Meeting
The Risk of Gastrointestinal Perforations Associated with Biologic Disease-Modifying Anti-Rheumatic Drugs Used in Rheumatoid Arthritis: A Nationwide Swedish Cohort Study
Andrei Barbulescu¹, Thomas Frisell¹, Johan Askling² and Bénédicte Delcoigne¹, ¹Clinical Epidemiology Unit, Department of Medicine, Solna, Karolinska Institutet, Stockholm, Sweden, ²Unit of Clinical Epidemiology, Department of Medicine, Solna, Karolinska Institutet, Stockholm, Sweden
Background/Purpose: Gastrointestinal (GI) perforations occur more often than expected in patients with RA. Reports indicate that tocilizumab may be associated with an increased risk of…
Abstract Number: 2141 • 2018 ACR/ARHP Annual Meeting
Development of a Pediatric Glucocorticoid Toxicity Index
Paul Brogan¹, Raymond P. Naden², Stacy P. Ardoin³, Jennifer C. Cooper⁴, Fabrizio De Benedetti⁵, Jean-Francois Dicaire⁶, Despina Eleftheriou⁷, Brian M. Feldman⁸, Jon Goldin⁹, Seth E. Karol¹⁰, Eli Miloslavsky¹¹, Fiona Price-Kuehne¹², David Skuse⁹, Constantine A. Stratakis¹³, Nicholas Webb¹⁴ and John H. Stone¹⁵, ¹Infection Inflammation and Rheumatology, UCL Institute of Child Health, and Great Ormond Street Hospital NHS Foundation Trust, London, United Kingdom, ²New Zealand Ministry of Health, New Zealand Ministry of Health, Auckland, New Zealand, ³The Ohio State University Wexner Medical Center, Columbus, OH, ⁴Pediatrics, Divison of Rheumatology, University of California, San Francisco, San Francisco, CA, ⁵IRCCS Ospedale Pediatrico Bambino Gesù, Roma, Italy, ⁶Pinnacle Inc., Quebec, QC, Canada, ⁷Infection, Inflammation and Rheumatology, UCL Institute of Child Health, London, United Kingdom, ⁸Rheumatology, The Hospital for Sick Children, Toronto, ON, Canada, ⁹Psychiatry, Great Ormond Street Hospital / University College London, London, United Kingdom, ¹⁰Oncology, St. Jude's Children's Hospital, Memphis, TN, ¹¹Division of Rheumatology, Massachusetts General Hospital, Harvard Medical School, Boston, MA, ¹²Rheumatology, Cambridge University Hospitals, Cambridge, United Kingdom, ¹³National Institute of Child Health and Human Development, Bethesta, MD, ¹⁴Pediatrics, Manchester University, Manchester, United Kingdom, ¹⁵Rheumatology (Medicine), Massachusetts General Hospital, Harvard Medical School, Boston, MA
Background/Purpose: A Glucocorticoid Toxicity Index app (GTI 2.0) is now used as a clinical trial outcome measure in adults, but glucocorticoid (GC) toxicity issues in…
Abstract Number: 2959 • 2018 ACR/ARHP Annual Meeting
Development of a Set of Potentially Preventable Adverse Conditions Specific to Lupus: A Delphi Consensus Study
Candace H. Feldman¹, Cameron Speyer¹, Rachel Ashby², Bonnie L. Bermas³, Shamik Bhattacharyya⁴, Eliza Chakravarty⁵, Brendan Everett⁶, Elizabeth Ferucci⁷, Aimee O. Hersh⁸, Francisco Marty⁹, Joseph F. Merola¹⁰, Rosalind Ramsey-Goldman¹¹, Brad Rovin¹², Mary Beth Son¹³, Laura Tarter¹⁴, Sushrut Waikar¹⁵, Jinoos Yazdany¹⁶, Joel Weissman¹⁷ and Karen Costenbader¹, ¹Division of Rheumatology, Immunology and Allergy, Brigham and Women's Hospital, Boston, MA, ²Obstetrics and Gynecology, Brigham and Women's Hospital, Boston, MA, ³Rheumatology, UT Southwestern, Dallas, TX, ⁴Neurology, Brigham and Women's Hospital, Boston, MA, ⁵Arthritis and Clinical Immunology, Oklahoma Medical Research Foundation, Oklahoma City, OK, ⁶Cardiology, Brigham and Women's Hospital, Boston, MA, ⁷Alaska Native Medical Center, Anchorage, AK, ⁸Pediatrics/Rheumatology, University of Utah, Salt Lake City, UT, ⁹Infectious Disease, Brigham and Women's Hospital, Boston, MA, ¹⁰Medicine, Rheumatology and Dermatology, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, ¹¹FSM, Northwestern University, Chicago, IL, ¹²Ohio State University Wexner Medical Center, Columbus, OH, ¹³Boston Children's Hospital, Harvard Medical School, Brookline, MA, ¹⁴Rheumatology, Immunology and Allergy, Brigham and Women's Hospital, Boston, MA, ¹⁵Renal, Brigham and Women's Hospital, Boston, MA, ¹⁶University of California, San Francisco, San Francisco, CA, ¹⁷Brigham and Women's Hospital, Boston, MA
Background/Purpose: The U.S. Agency for Healthcare Research and Quality developed a set of general ambulatory care-sensitive conditions that may result acute care use (hospitalizations and…
Abstract Number: 1190 • 2018 ACR/ARHP Annual Meeting
Use of Biologic Drugs and Adverse Events in Patients with Rheumatic Disease: DATA from the Mexican Biologics Registry
Daniel Xibille-Friedmann¹, Sandra Miriam Carrillo -Vazquez², Sandra Sicsik Ayala³, Fedra Irazoque-Palazuelos⁴, Azucena Ramos-Sanchez⁵, Sergio Duran-Barragan⁶, Miguel A Saavedra⁷, Leonor Barile⁸ and Guadalupe Olvera⁹, ¹Research and Training Department, Servicios de Salud de Morelos, Cuernavaca, Mexico, ²Rheumatology, Hospital 1 de Octubre ISSSTE, Mexico City, Mexico, ³Rheumatology, UMAE 71 IMSS, Torreon, Mexico, Torreon, Mexico, ⁴Rheumatology Department, CMN 20 de Noviembre ISSSTE,, CDMX, Mexico, ⁵Rheumatology, CMN NE 25 IMSS, Monterrey, Mexico, ⁶Centro Universitario de Ciencias de la Salud, Instituto de Investigación en Reumatología y del Sistema Músculo Esquelético, Universidad de Guadalajara, Guadalajara, Mexico, ⁷Novartis Farmaceutica, Calz de Tlaplan 1779, Mexico, Mexico, ⁸Hospital Ángeles del Pedregal, Mexico, Mexico, ⁹Research Department, Colegio Mexicano de Reumatologia, Mexico City, Mexico
Background/Purpose: National registries of biologic drugs have proven to be valuable tools in following patients with rheumatic disease and some outcomes in real-life situations. The…

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