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Abstracts tagged "biosimilars"

  • Abstract Number: 549 • 2019 ACR/ARP Annual Meeting

    US Rheumatologists’ Beliefs and Knowledge About Biosimilars – an Ongoing Survey

    Allan Gibofsky1, Dorothy McCabe 2 and Sam Badawi 2, 1Weill Cornell Medical College, New York, NY, 2Boehringer Ingelheim, Ridgefield, CT

    Background/Purpose: A systematic review of survey literature from 2014-2018 found that clinicians in the US and Europe are cautious about biosimilar use (JMCP; 2019;25:102). We…
  • Abstract Number: 1115 • 2019 ACR/ARP Annual Meeting

    Switching Patterns Among Patients with Chronic Inflammatory Diseases Switching to an Infliximab Biosimilar or Remaining on Originator Infliximab (REMICADE)

    Bruno Emond 1, Kay Sadik 2, Marie-Hélène Lafeuille 1, Willy Wynant 1, Aurélie Côté-Sergent 1, Patrick Lefebvre 1, Kimberly Woodruff 2 and Timothy Fitzgerald3, 1Analysis Group, Inc, Montreal, QC, Canada, 2Janssen Scientific Affairs, LLC, Titusville, NJ, 3Janssen Scientific Affairs, LLC, Horsham, PA

    Background/Purpose: Chronic inflammatory diseases (CIDs) such as rheumatoid arthritis (RA), psoriatic arthritis (PsA), plaque psoriasis (PsO), ankylosing spondylitis (AS), Crohn's disease (CD), and ulcerative colitis…
  • 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: 1118 • 2019 ACR/ARP Annual Meeting

    US Community Rheumatologists’ Knowledge and Perceptions of Biosimilar Expanded Indication Approval by Extrapolation

    Ting-Chun Yeh1, Yolaine Jeune-Smith 1, Eli Phillips 1, Ajeet Gajra 1 and Bruce Feinberg 1, 1Cardinal Health Specialty Solutions, Dublin, OH

    Background/Purpose: To expand treatment options, increase access to life-saving medications, and lower healthcare costs through competition, the US Congress created an abbreviated licensure pathway for…
  • Abstract Number: 2534 • 2018 ACR/ARHP Annual Meeting

    Impact of Block Switch to Biosimilar Etanercept in Practice, Accross Different Rheumatic Diseases

    Luisa Brites1, Flavio Costa2, João Freitas3, Mariana Luis4, Margarida Coutinho4, Mariana Santiago3, Cátia Duarte5, Maria Joao Salvador4 and José António P. da Silva6, 1Rheumatology, Centro Hospitalar e Universitário de Coimbra, Coimbra, Portugal, 2Rheumatology Department, Centro Hospitalar e Universitario de Coimbra, Coimbra, Portugal, 3Rheumatology, Centro Hospitalar e Universitário de Coimbra, CHUC-EPE, Coimbra, Portugal, 4Centro Hospitalar e Universitário de Coimbra, Coimbra, Portugal, 5Faculty of Medicine, Universidade de Coimbra, Coimbra, Portugal, 6Department of rheumatology, Centro Hospitalar e Universitário de Coimbra (SRHUC), Coimbra, Portugal

    Background/Purpose: Biosimilars of biotechnological agents represent an important opportunity to increase accessibility to these medications. Clinicians still maintain reservations regarding the similarity of their efficacy…
  • Abstract Number: 2617 • 2018 ACR/ARHP Annual Meeting

    Prolonged Effectiveness of a 12 Week Regimen of Biosimilar Adalimumab in Indian (Asian) Patients Suffering from Symptomatic Acute-Chronic Ankylosing Spondylitis (AS)

    Arvind Chopra1, Nagnath Khadke2, Manjit Saluja3, Toktam Kainifard4 and Anuradha Venugopalan5, 1Center for Rheumatic Diseases, Pune, India, 2Rheumatolgy, Consultant, Pune, India, 3Rheumatology, Research Co-ordinator, Pune, India, 4Rheumatology, Consultant research and Dietitian, Tehran, Iran (Islamic Republic of), 5Rheumatology, R & D, Lab, Center for Rheumatic Diseases, Pune, India

    Background/Purpose: On regulatory approval in India, challenging socioeconomics and infection prone scenario compelled us to seek prolonged effectiveness of short term anti-TNF therapeutic  regimen (Chopra…
  • Abstract Number: 216 • 2018 ACR/ARHP Annual Meeting

    Inflectra and Remicade Use and Cost in Canada Under Provincial Drug Plans in 2016

    Cristiano S. Moura1, Denis Choquette2, Gilles Boire3, Vivian P. Bykerk4, Carter Thorne5, Walter P. Maksymowych6, Peter Lakatos7, Talat Bessissow8, Larry Svenson9, Laura Targownik10, Waqqas Afif8 and Sasha Bernatsky11, 1The Centre for Outcomes Research and Evaluation (CORE), McGill University Health Centre, Montreal, QC, Canada, 2Osteoarthritis Research Unit, University of Montreal Hospital Research Centre (CRCHUM), Notre-Dame Hospital, Montreal, QC, Canada, 3Rheumatology Division, Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke and Universite de Sherbrooke, Sherbrooke, QC, Canada, 4Hospital for Special Surgery, New York, NY, 5University of Toronto, Newmarket, ON, Canada, 6Department of Medicine, CaRE Arthritis and University of Alberta, Edmonton, Canada, Edmonton, AB, Canada, 7Medicine, Gastroenterology, McGill University, Montreal, QC, Canada, 8Gastroenterology, McGill University, Montreal, QC, Canada, 9Division of Preventive Medicine, University of Alberta, Edmonton, AB, Canada, 10Gastroenterology, University of Manitoba, Winnipeg, MB, Canada, 11Divisions of Rheumatology and Clinical Epidemiology, The Research Institute of the McGill University Health Centre, Montreal, QC, Canada

    Background/Purpose: Inflectra (infliximab) was the first biosimilar for inflammatory bowel disease and/or arthritis, approved by Health Canada on the belief that it is as safe…
  • Abstract Number: 559 • 2018 ACR/ARHP Annual Meeting

    Radiographic Progression Based on Baseline Demographics and Disease Characteristics from Three TNF-Alpha Inhibitor Biosimilar Studies in Patients with Rheumatoid Arthritis

    Josef S. Smolen1, Young Mo Kang2, Wan-Hee Yoo3, Paul Emery4, Michael E Weinblatt5, Edward C. Keystone6, Mark C. Genovese7, Gihyun Myung8, Evelyn Hong8, Inyoung Baek8 and Jeehoon Ghil8, 1Division of Rheumatology, Department of Medicine 3, Medical University of Vienna, Vienna, Austria, 2Kyungpook National University School of Medicine, Daegu, Korea, Republic of (South), 3Chonbuk National University School of Medicine, Jeonju, Korea, Republic of (South), 4University of Leeds and NIHR Leeds Biomedical Research Centre, Leeds, United Kingdom, 5Brigham and Women's Hospital, Boston, MA, 6Mount Sinai Hospital, Toronto, ON, Canada, 7Stanford University Medical Center, Palo Alto, CA, 8Samsung Bioepis Co., Ltd., Incheon, Korea, Republic of (South)

    Background/Purpose: SB4, SB2, and SB5 are biosimilars of reference etanercept, infliximab, and adalimumab, respectively. Radiographic data were assessed using the modified Total Sharp Score (mTSS)…
  • Abstract Number: 977 • 2018 ACR/ARHP Annual Meeting

    Nurse Led Safe Switching from Original Reference Product Infliximab to Biosimalar in Patients with Juvenile Idiopathic Arthritis and Uveitis – a Single Centre Experience Including Baseline and Post Switch Infliximab Levels and Antibodies

    Andrew Fell1, Emma Carson1, Gillian Coyle1, Neil Martin1, Jo Walsh1 and Janet Gardner-Medwin2, 1Paediatic Rheumatology, Royal hospital for Children, Glasgow, United Kingdom, 2School of Medicine, Dentistry & Nursing, Child Health, University of Glasgow, Glasgow, United Kingdom

    Background/Purpose: Original Reference Product (ORP) Infliximab lost market exclusivity in europe in early 2015. The Scottish National Health service (SNHS), runs a national procurement system…
  • Abstract Number: 1532 • 2018 ACR/ARHP Annual Meeting

    Impact of Immunogenicity on Clinical Efficacy and Administration Related Reaction in TNF Inhibitors: A Pooled-Analysis from Three Biosimilar Studies in Patients with Rheumatoid Arthritis

    Paul Emery1, Michael E Weinblatt2, Josef S. Smolen3, Edward C. Keystone4, Mark C. Genovese5, Jiri Vencovsky6, Jonathan Kay7, Evelyn Hong8 and Jeehoon Ghil8, 1University of Leeds and NIHR Leeds Biomedical Research Centre, Leeds, United Kingdom, 2Rheumatology, Immunology and Allergy, Brigham and Women's Hospital, Boston, MA, 3Division of Rheumatology, Department of Medicine 3, Medical University of Vienna, Vienna, Austria, 4Mount Sinai Hospital, Toronto, ON, Canada, 5Stanford University Medical Center, Palo Alto, CA, 6Institute of Rheumatology and Department of Rheumatology, 1st Faculty of Medicine, Charles University, Czech Republic, Prague 2, Czech Republic, 7UMass Memorial Medical Center and University of Massachusetts Medical School, Worcester, MA, 8Samsung Bioepis Co., Ltd., Incheon, Korea, Republic of (South)

    Background/Purpose: SB4, SB2, and SB5 are biosimilars of reference etanercept, infliximab, and adalimumab, respectively. The phase III randomized, double-blind clinical studies comparing the efficacy and…
  • Abstract Number: 1769 • 2018 ACR/ARHP Annual Meeting

    Efficacy and Safety of Biomimic Rituximab in Granulomatosis with Polyangiitis – Experience from a Single Tertiary Care Centre in India

    Aman Sharma1, Sakshi Mittal2, GSRSNK Naidu3, Saket Jha2, Manish Rathi4, Vikas Sharma2, Arghya Chattopadhyay5, Varun Dhir6, Kusum Sharma7, Ranjana Minz8, Ritambhra Nada9 and Sanjay Jain10, 1Clinical Immunology and Rheumatology Services, Department of Internal Medicine, Postgraduate Institute of Medical Education and Research, Chandigarh, India, Chandigarh, India, 2Internal Medicine, PGIMER, Chandigarh, India, 3PGIMER, cHANDIGARH, India, 4Department of Nephrology,, Postgraduate Institute of Medical Education and Research, Chandigarh, India, 5PGIMER, Chandigarh, India, 6Internal Medicine (Rheumatology Unit), Postgraduate Institute of Medical Education and Research, Chandigarh, India, Chandigarh, India, 7Department of Medical Microbiology,, PGIMER,, Chandigarh, India, 8Department of Immunopathology,, PGIMER,, Chandigarh, India, 9Postgraduate Institute of Medical Education and Research, Chandigarh, India, 10Postgraduate Institute of Medical Education and Research, Chandigarh, India, CHANDIGARH, India

    Background/Purpose: Though rituximab(RTX) has become a standard of care for remission induction and maintenance in Granulomatosis with Polyangiitis(GPA), there is very limited data on the…
  • Abstract Number: 1936 • 2018 ACR/ARHP Annual Meeting

    A Randomized, Double-Blind, Parallel-Group, Multicenter Study to Compare the Efficacy, Safety and Immunogenicity of a Proposed Adalimumab Biosimilar (GP2017) with Reference Adalimumab in Patients with Moderate-to-Severe Active Rheumatoid Arthritis

    Piotr Wiland1, Sławomir Jeka2, Eva Dokoupilová3,4, Juan Manuel Miranda Limón5, Julia Jauch-Lembach6, Anjali Thakur6, Halimuniyazi Haliduola6 and Norman B Gaylis7, 1Wrocław Medical University, Wrocław, Poland, 2Collegium Medicum UMK, 2nd University Hospital, Bydgoszcz, Poland, 3MEDICAL PLUS s.r.o., Uherské Hradiště, Czech Republic, 4Faculty of Pharmacy, University of Veterinary and Pharmaceutical sciences, Brno, Czech Republic, 5RM Pharma Specialists, Mexico City, Mexico, 6Hexal AG, Holzkirchen, Germany, 7Arthritis & Rheumatic Disease Specialties, Aventura, FL

    Background/Purpose: GP2017, a proposed adalimumab biosimilar, matched reference adalimumab (refADL) in preclinical and pharmacokinetics studies.1,2 The confirmatory efficacy and safety study in patients with plaque-type…
  • Abstract Number: 2154 • 2018 ACR/ARHP Annual Meeting

    Biosimilar Infliximab Treated-Patients with Rheumatoid Arthritis, Psoriatic Arthritis, and Ankylosing Spondylitis in France: Characteristics and Clinical Outcomes

    Hubert Marotte1, NADIR MAMMAR2 and Bruno Fautrel3, 1University Hospital of Saint Etienne,, Saint Etienne, France, 2Pfizer, PARIS, France, 3Institut Pierre Louis d'Epidémiologie et de Santé Publique (iPLESP), UMR S 1136, Sorbonne Université, GRC-UPMC 08, Paris, France

    Background/Purpose: CT-P13 was the first monoclonal antibody biosimilar to infliximab (IFX) approved in France. Reflect trial has been set up to evaluate in real life…
  • Abstract Number: 2367 • 2018 ACR/ARHP Annual Meeting

    Acceptance Rate and Sociological Factors Involved in the Switch from Originator to Biosimilar Etanercept (SB4)

    Marc Scherlinger1,2,3, Vincent Germain1, Emmanuel Langlois4 and Thierry Schaeverbeke5, 1Department of Rheumatology, Bordeaux University Hospital, Bordeaux, France, 2FHU ACRONIM, Bordeaux, France, 3Rheumatology, UMR CNRS 5164 - Immunoconcept, France, Bordeaux, France, 4CNRS-UMR 5116 Centre Emile Durkheim, Bordeaux, France, 5Department of Rheumatology, Bordeaux University Hospital, BORDEAUX, France

    Background/Purpose: Biosimilars represent major potential savings while preserving treatment quality. However, few data are known on how to address the switch from originator to biosimilar…
  • Abstract Number: 2384 • 2018 ACR/ARHP Annual Meeting

    Biosimilar Use in Young Adults with Juvenile Idiopathic Arthritis in Germany

    Jens Klotsche1, Martina Niewerth1, Gerd Horneff2 and Kirsten Minden3,4, 1Program Area Epidemiology, German Rheumatism Research Center, Berlin, Germany, 2Department of Pediatrics, Asklepios Clinics St. Augustin, Sankt Augustin, Germany, 3Charité–Universitätsmedizin Berlin, Berlin, Germany, 4German Rheumatism Research Center, Berlin, Germany

    Background/Purpose: The first biosimilars have been approved for the treatment of juvenile idiopathic arthritis (JIA) in the last two years. To date, only a few…
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