ACR Meeting Abstracts

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Abstracts tagged "drug safety"

  • Abstract Number: 047 • 2020 Pediatric Rheumatology Symposium

    Patients with Juvenile Idiopathic Arthritis in the Childhood Arthritis and Rheumatology Research Alliance (CARRA) Registry: Clinical Characteristics and Inception Cohorts

    Yongdong Zhao1, Timothy Beukelman 2, Yukiko Kimura 3, Mara Becker 4, Sarah Ringold 5, Anne Dennos 6 and Laura Schanberg 7 for the CARRA investigators, 1University of Washington, Seattle, 2University of Alabama at Birmingham, Birmingham, 3Hackensack Meridian School of Medicine, Hackensack, 4Duke University Medical Center/Duke Clinical Research Institute, Chapel Hill, 5Seattle Children's, Seattle, 6Duke University, Durham, 7Duke University Hospital, DURHAM

    Background/Purpose: In July 2015, the CARRA Registry was re-established as a multi-center observational study that collects essential data from patients with childhood-onset rheumatic diseases. The…
  • Abstract Number: 050 • 2020 Pediatric Rheumatology Symposium

    Long Term Safety of Biologics and Biosimilars in Pediatric Rheumatic Diseases: An Experience from a Single North Indian Centre

    MANJARI AGARWAL 1, Sujata Sawhney2 and Anju Singh 3, 1Sir Ganga Ram Hospital, NEW DELHI, Delhi, India, 2Sir ganga ram hospital, Sector 37 noida, Uttar Pradesh, India, 3Sir Ganga Ram Hospital, delhi, India

    Background/Purpose:  The use of biologic response modifiers(BRMs) is associated with an increased risk of infections.We also use biosimilars for two reasons:1. originator not available, like…
  • Abstract Number: L12 • 2019 ACR/ARP Annual Meeting

    Safety and Efficacy of Olokizumab in a Phase III Trial of Patients with Moderately to Severely Active Rheumatoid Arthritis Inadequately Controlled by Methotrexate – CREDO1 Study

    Evgeniy Nasonov 1, Saeed Fatenejad 2, Elena Korneva 3, Diana Krechikova 4, Alexey Maslyansky 5, Tatyana Plaksina 6, Marina Stanislav 7, Rumen Stoilov 8, Tamara Tyabut 9, Sergey Yakushin 10, Elena Zonova 11 and Mark Genovese12, 1FSBSI "Scientific Research Institute of Rheumatology n.a. V.A. Nasonova", Moscow, Russia, 2SFC Medica, Charlotte, North Carolina, 3R-Pharm, Moscow, Russia, 4Non-governmental Healthcare Institution "Regional Clinical Hospital at Smolensk station of OJSC "Russian Railways, Smolensk, Russia, 5SBHI "North-West Federal Medical Research Center n.a. V.A.Almazov" of the Ministry of Healthcare of the Russian Federation, St-Petersburg, Russia, 6SBHI of Nizhny Novgorod Region "Nizhny Novgorod Regional Clinical Hospital n.a. P.A.Semashko", N.Novgorod, Russia, 7V.A. Nasonova Research Rheumatology Institute, Moscow, Russia, 8UMHAT St. Ivan Rilski, Clinic of Rheumatology, Sofia, Bulgaria, 9Belarusian Medical Academy of Postgraduate Education, City Clinical Hospital N1, Minsk, Belarus, 10Ryazan State Medical University, Ryazan, Russia, 11Novosibirsk State Medical University, State Clinical Polyclinic 1, Novosibirsk, Russia, 12Stanford University, Stanford, CA

    Background/Purpose: Olokizumab (OKZ) is a new humanized monoclonal antibody targeting IL-6 1, 2. Here we present the results of the first phase III study of…
  • Abstract Number: 267 • 2019 ACR/ARP Annual Meeting

    Develop Risk Prediction Model and Drug Withdrawl Road Map Through Pattern Extraction and Data Mining: Create a Master Algorithm from the Smart System of Disease Management (SSDM)

    Yan Zhao1, Xiaomei Li 2, Rong Mu 3, Xiaoxia Zuo 4, Hua Wei 5, Lingli Dong 6, Shouxin Li 6, Hongsheng Sun 7, Guanmin Gao 8, Lijun Wu 9, Bing Wu 10, Yuhua Jia 11, Hui Xiao 12, Minghua Xu 13, Wenyu Zhou 14, Aichun Chu 15, Li Dong 16, Huiqin Yang 17, Ming Gui 18, Weiqi Min 19, Zhenchun Zhang 20, Ying Pan 21, Junli Zhang 22, Jinchang He 23, Haiying Chen 24 and Fei Xiao 25, 1Peking Union Medical College hospital, Beijing, Beijing, China (People's Republic), 2the First Affiliated Hospital of University of Science and Technology of China, Hefei, China (People's Republic), 3People's Hospital, Beijing University Medical School, Beijing, China (People's Republic), 4Xiangya Hospital Centeral South University, Changsha, China (People's Republic), 5Northern Jiangsu People's Hospital, Yangzhou, China (People's Republic), 6Tongji Hospital,Tongji Medical Colllege,Huazhong University of Science and Technology, Wuhan, Hubei, China (People's Republic), 7Shandong Provincial Hospital Affiliated to Shandong University, Jinan, China (People's Republic), 8the First Affiliated Hospital of Zhengzhou University, Zhengzhou, China (People's Republic), 9People's Hospital of Xinjiang Uygur Autonomous region, Wulumuqi, Xinjiang, China (People's Republic), 10Shanghai Gothic Internet Technology Co., Ltd, Shanghai, China (People's Republic), 11Shanghai Gothic Internet Technology Co., Ltd., Shanghai, Shanghai, China (People's Republic), 12Shanghai Gothic Internet Technology Co., Ltd, shanghai, Shanghai, China (People's Republic), 13Affiliated Hospital of Hebei University, Baoding, China (People's Republic), 14WuHan Fourth Hospital, Wuhan, China (People's Republic), 15Hubei general hospital, Wuhan, China (People's Republic), 16Jingzhou Central Hospital, Jingzhou, China (People's Republic), 17Wuhan NO.1 Hospital, Wuhan, China (People's Republic), 18The third xiangya hospital of central south university, Changsha, China (People's Republic), 19Heze municipal hospital, Heze, China (People's Republic), 20Linyi People's Hospital, Linyi, China (People's Republic), 21the First Affiliated Hospital of xi'an Jiaotong University, Xi'an, China (People's Republic), 22Xi'an Fifth Hospital, Xian, China (People's Republic), 23Panzhihua Central Hospital, Panzhihua, China (People's Republic), 24The Third Hospital of Hebei Medical University, Shijiazhang, China (People's Republic), 25Shanghai Gothic Internet Technology Co., Ltd., shanghai, China (People's Republic)

    Background/Purpose: Combination therapy with DMARDs for treating RA is considered as a standard of care. However, certain rates of adverse events (AEs) are unavoidable. The…
  • Abstract Number: 1326 • 2019 ACR/ARP Annual Meeting

    Safety Profile to Date of the Novel, Intra-articular Agent Lorecivivint (LOR; SM04690), a CLK/DYRK1A Inhibitor That Modulates the Wnt Pathway, in Subjects with Knee Osteoarthritis

    Ismail Simsek 1, Chris Swearingen 1, Sarah Kennedy 1, Jeyanesh Tambiah 1, Yusuf Yazici2, Nancy Lane 3 and Marc C. Hochberg 4, 1Samumed, LLC, San Diego, 2Samumed, LLC, San Diego, CA, 3University of California at Davis Medical Center, Sacramento, CA, 4University of Maryland School of Medicine, Baltimore, MD

    Background/Purpose: Recent concerns over osteoarthritis (OA) pharmacotherapy safety have led to revision of treatment guidelines and highlight the need for therapies with good safety profiles.…
  • 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: 1331 • 2019 ACR/ARP Annual Meeting

    No Confirmation of Increased Risk of Idiopathic Facial Nerve Palsy Under Tocilizumab

    Anja Strangfeld1, Yvette Meissner 2, Martin Schaefer 3, Lisa Baganz 2, Matthias Schneider 4, Elke Wilden 5, Silke Zinke 6 and Angela Zink 7, 1German Rheumatism Research Center (DRFZ), Berlin, Germany, 2German Rheumatism Research Centre, Berlin, Germany, 3German Rheumatism Research Center, Berlin, Germany, 4Policlinic for Rheumatology & Hiller Research Centre for Rheumatology, Heinrich-Heine-University Duesseldorf, Düsseldorf, Germany, 5Rheumatologist, Cologne, Germany, 6Rheumatologist, Berlin, Germany, 7German Rheumatism Research Centre and Charité University medicine, Berlin, Germany

    Background/Purpose: Spontaneous reports of nine facial paralyses and five facial pareses made by healthcare professionals from Europe have recently prompted EMA’s Pharmacovigilance Risk Assessment Committee…
  • Abstract Number: 1418 • 2019 ACR/ARP Annual Meeting

    Predictors of Response, Adverse Events and Treatment Retention in RA Patients Treated with Either Subcutaneous- or Intravenous- Golimumab in a Prospective, Observational Registry

    Proton Rahman 1, Rafat Faraawi 2, Louis Bessette 3, Andrew Chow 4, Jodie Reis 5, Keltie Anderson 5, Emmanouil Rampakakis 6, Meagan Rachich 7, Odalis Asin-Milan 7, Allen Lehman 7 and Francois Nantel7, 1Memorial University, Newfoundland, NL, Canada, 2McMaster University, Hamilton, ON, Canada, 3Laval University, Laval, QC, Canada, 4Credit Valley Rheumatology, Mississauga, ON, Canada, 5University of Saskatchewan, Saskatoon, SK, Canada, 6JSS Medical Research, Montreal, Canada, 7Janssen Inc., Toronto, ON, Canada

    Background/Purpose: The Biologic Treatment Registry Across Canada (BioTRAC) was a prospective, observational registry that enrolled rheumatoid arthritis (RA) patients treated with either subcutaneous golimumab (GLM-SC)…
  • Abstract Number: 1890 • 2019 ACR/ARP Annual Meeting

    Methotrexate Adverse Events in a Randomized Double-Blind Placebo-Controlled Trial:Results from the Cardiovascular Inflammation Reduction Trial (CIRT)

    Daniel Solomon1, Robert Glynn 2, Elizabeth Karlson 3, Fengxin Lu 3, Cassandra Corrigan 3, Joshua Colls 3, Chang Xu 3, Jean MacFadyen 3, Medha Barbhaiya 4, Nancy Berliner 3, Paul Dellaripa 3, Brendan Everett 3, Sara Hammond 3, Meredith Murray 3, Deepak Rao 3, Susan Ritter 5, Anna Rutherford 5, Jeffrey Sparks 3, Jacklyn Stratton 5, Dong Suh 3, Sara K. Tedeschi 6, Kathleen Vanni 3, Nina Paynter 5 and Paul Ridker 5, 1Brigham and Women´s Hospital, Div. of Rheumatology, Immunology and Allergy, Boston, MA, 2Harvard Medical School - Boston, MA, Boston, MA, 3Brigham and Women's Hospital, Boston, MA, 4Hospital for Special Surgery, Weill Cornell Medicine, New York, NY, 5Brigham and Women's Hospital, Boston, 6Brigham and Women's Hospital, Div. of Rheumatology, Immunology and Allergy, Boston, MA

    Background/Purpose: Prior observational studies have estimated the risk of adverse events with low dose methotrexate (MTX). However, prior randomized controlled trials (RCT) were too small…
  • Abstract Number: 2120 • 2019 ACR/ARP Annual Meeting

    No Evidence of an Increased Risk of Serious Infections Among 3 Classes of Biologics for Psoriasis or Psoriatic Arthritis: A Retrospective Real-World Cohort Study

    Xintong Li 1, Kathleen M Andersen2, Hsien-Yen Chang 3, G. Caleb Alexander 4 and Jeffrey Curtis 5, 1Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, 2Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health,, Baltimore, MD, 3Johns Hopkins Bloomberg School of Public Health, Baltimore, 4Johns Hopkins Bloomberg School of Public Health. Center for Drug Safety and Effectiveness, Baltimore, MD, 5University of Alabama at Birmingham, Birmingham, AL

    Background/Purpose: The real-world risk of serious infections associated with interleukin (IL) and tumor necrosis factor-alpha (TNF-α) inhibitors for patients with psoriasis (PsO) and psoriatic arthritis…
  • Abstract Number: 2357 • 2019 ACR/ARP Annual Meeting

    Methotrexate Liver Toxicity in a Large Randomized Controlled Trial

    Daniel Solomon1, Nina Paynter 2, Anna Rutherford 2, Robert Glynn 3, Jean MacFadyen 4, Fengxin Lu 4, Chang Xu 4, Elizabeth Karlson 4 and Paul Ridker 2, 1Brigham and Women´s Hospital, Div. of Rheumatology, Immunology and Allergy, Boston, MA, 2Brigham and Women's Hospital, Boston, 3Harvard Medical School - Boston, MA, Boston, MA, 4Brigham and Women's Hospital, Boston, MA

    Background/Purpose: Liver test abnormalities are known to predict liver pathology in patients using methotrexate (MTX). Monitoring guidelines for MTX suggest frequent assessment of liver tests…
  • Abstract Number: 2358 • 2019 ACR/ARP Annual Meeting

    Short-term Risk of Major Adverse Cardiovascular Events or Venous Thrombo-embolic Events in Patients with Rheumatoid Arthritis Initiating a Janus Kinase Inhibitor: A Meta-analysis of Randomised Controlled Trials

    Margaux MALAURIE1, Arnaud Constantin 2, Yannick Degboé 1, Adeline Ruyssen-Witrand 3 and Thomas Barnetche 4, 1CHU TOULOUSE, TOULOUSE, France, 2CHU TOUOUSE, TOULOUSE, France, 3Rheumatology Unit, Toulouse university Hospital, UMR 1027, Inserm, Université Paul Sabatier Toulouse III, Toulouse, France, 4FHU ACRONIM, Department of Rheumatology, Centre Hospitalier Universitaire, Bordeaux, France, Bordeaux, France

    Background/Purpose: The objective was to investigate the short-term risk of major adverse cardiovascular events (MACEs) or venous thromboembolic events (VTEs) in patients with rheumatoid arhthritis…
  • Abstract Number: 2529 • 2019 ACR/ARP Annual Meeting

    Safety of Chloroquine and Hydroxychloroquine During Pregnancy: A Systematic Review and Meta-Analysis

    Thibaut Naveau 1, Olivier Lichau 1, Thomas Barnetche 1, Thierry Schaeverbeke 1, Estibaliz Lazaro 2, Marie-Elise Truchetet 3 and Christophe Richez4, 1FHU ACRONIM, Department of Rheumatology, Centre Hospitalier Universitaire, Bordeaux, France, Bordeaux, France, 2FHU ACRONIM, Department of Internal Medecine, Centre Hospitalier Universitaire, Bordeaux, France, Pessac, France, 3FHU ACRONIM, Department of Rheumatology, Centre Hospitalier Universitaire, Bordeaux, France. Bordeaux University, CNRS 5164, 33000 Bordeaux, France, Bordeaux, France, 4Pellegrin Hospital, University Hospital of Bordeaux, Bordeaux, France

    Background/Purpose: Chloroquine (CQ) and Hydroxychloroquine (HCQ) have been used for years during pregnancy for multiple indications (malaria prevention, autoimmune disorders, etc.…). Recently, some countries face…
  • Abstract Number: 2547 • 2019 ACR/ARP Annual Meeting

    Safety Results of 50% Enrollment from a Multicenter, Randomized, Double‑blind, Placebo‑controlled Study to Assess the Efficacy and Safety of Repository Corticotropin Injection in Patients with Systemic Lupus Erythematosus Despite Moderate‑dose Corticosteroid Use

    Anca Askanase1, Dharani Munirathinam 2, Enxu Zhao 2, Julie Zhu 2, Erin Connolly-Strong 2 and Richard Furie 3, 1Columbia University Medical Center, New York, NY, 2Mallinckrodt Pharmaceuticals, ARD, LLC, Bedminster, NJ, 3Northwell Health, Great Neck, NY

    Background/Purpose: Repository corticotropin injection (RCI) is a naturally sourced complex mixture of adrenocorticotropic hormone (ACTH1-39) analogues and other pituitary peptides that stimulates endogenous corticosteroid (CS)…
  • 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…
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