ACR Meeting Abstracts

ACR Meeting Abstracts

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Abstracts tagged "biosimilars"

  • Abstract Number: 0745 • ACR Convergence 2021

    Patient-reported Outcomes and Safety Measures in Patients with Rheumatic Diseases Who Switched from Reference or Other Biosimilar Etanercept to Biosimilar Etanercept GP2015 and in Biologic-naïve Patients Starting a Treatment with GP2015: 12-month Interim Analysis from a Real-world Study

    Ayman Askari1, Marc Schmalzing2, Slawomir Jeka3, Javier De Toro Santos4, Eduardo Collantes-Estevez5, Fabricio Furlan6, Sohaib Hachaichi6 and Herbert Kellner7, 1The Robert Jones and Agnes Hunt Orthopaedic Hospital, Shropshire, United Kingdom, 2Rheumatology/Clinical Immunology, Department of Internal Medicine II, University of Wuerzburg, Wuerzburg, Germany, 3Clinic and Department of Rheumatology and Connective Tissue Diseases, University Hospital No 2 in Bydgoszcz Collegium Medicum UMK in Toruń, Bydgoszcz, Poland, 4University Hospital Coruña, Servicio de Reumatología, A Coruña, Galicia, Spain, 5IMIBIC/Reina Sofia Hospital/University of Córdoba, Córdoba, Spain, 6Hexal AG (A Sandoz company), Holzkirchen, Germany, Holzkirchen, Germany, 7Hospital Neuwittelsbach, Center for Rheumatology and Gastroenterology, Munich, Germany, Munich, Germany

    Background/Purpose: GP2015 is a biosimilar of etanercept (ETN). COMPACT is an ongoing, non-interventional study, evaluating the effectiveness, safety, and quality of life with GP2015 treatment…
  • Abstract Number: 0823 • ACR Convergence 2021

    Pharmacokinetic and Pharmacodynamic Evaluation of a Proposed Biosimilar MSB11456 versus Both the US-licensed and EU-approved Tocilizumab: Results of a Randomized, Double-blind, Parallel-group, Single-dose Trial in Healthy Adults

    Christian Schwabe1, Chris Wynne2, Andras Illes3, Martin Ullmann3, Emmanuelle Vincent3, Vishal Ghori3, Corinne Petit-Frere3, Anne-Sophie Racault3 and Joelle Monnet3, 1Auckland Clinical Studies Ltd, Auckland, New Zealand, 2Christchurch Clinical Studies Trust Ltd, Christchurch, New Zealand, 3Fresenius Kabi SwissBioSim, Eysins, Switzerland

    Background/Purpose: Tocilizumab, a biologic disease-modifying antirheumatic drug, is a recombinant humanized monoclonal immunoglobulin G1 antibody against the interleukin-6 receptor (IL-6R). MSB11456 is a proposed biosimilar…
  • Abstract Number: 042 • 2020 Pediatric Rheumatology Symposium

    Safety Analysis of Infliximab-dyyb as Compared to Infliximab in Pediatric Rheumatic Conditions

    Mary Culp 1, Dusty Lewis 1, Bethanne Thomas 2, Fatima Barbar-Smiley 3, Kyla Driest 4, Edward Oberle 4, Stacy Ardoin 1 and Kelly Wise1, 1Nationwide Children's Hospital, Columbus, 2Nationwide Children's, Columbus, 3Nationwide Children's Hospital, Columbus, Ohio, 4Division of Rheumatology, Nationwide Children's Hospital, Columbus

    Background/Purpose: Infliximab is an effective treatment for many pediatric rheumatic conditions, but high medication cost creates a barrier to patient access. Biosimilar drugs are proven…
  • 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: 2406 • 2019 ACR/ARP Annual Meeting

    Hepatobiliary Events in >5000 Patients with Inflammatory Arthritis Treated with Biosimilar or Originator Etanercept in Routine Care, Results from the Danish Nationwide DANBIO Registry

    Bente Glintborg 1, Stylianos Georgiadis 2, Mette Nørgaard 3, Frank Mehnert 3, Kathrine Lederballe Grøn 1, Niels Steen Krogh 4 and Merete Lund Hetland1, 1DANBIO and Copenhagen Center for Arthritis Research (COPECARE), Center for Rheumatology and Spine Diseases, Centre of Head and Orthopaedics, Rigshospitalet, Copenhagen, Denmark, 2DANBIO registry and Copenhagen Center for Arthritis Research, Centre for Rheumatology and Spine Diseases, Rigshospitalet, Copenhagen, Denmark, 3Department of Clinical Epidemiology, Aarhus University Hospital, Aarhus, Denmark, 4Zitelab / DANBIO, Copenhagen, Denmark

    Background/Purpose: Marketing of biosimilar biological drugs may significantly reduce drug costs if comparable safety and efficacy of originator and the biosimilar can be documented. In…
  • Abstract Number: 205 • 2019 ACR/ARP Annual Meeting

    Does a Mandatory Non-medical Switch from Originator to Biosimilar Etanercept Lead to Increase in Healthcare Use and Costs? A Danish Register-based Study of 1620 Patients with Inflammatory Arthritis

    Bente Glintborg 1, Rikke Ibsen 2, Rebekka Elisabeth Qwist Bilbo 3, Merete Lund Hetland1 and Jakob Kjellberg 3, 1DANBIO and Copenhagen Center for Arthritis Research (COPECARE), Center for Rheumatology and Spine Diseases, Centre of Head and Orthopaedics, Rigshospitalet, Copenhagen, Denmark, 2i2minds, Aarhus, Denmark, 3VIVE, The Danish Centre for Social Science Research, Copenhagen, Denmark

    Background/Purpose: Marketing of cheaper biosimilar biological agents has created financial incentives for switching from the corresponding originator drugs (=non-medical switch). The economic benefit might potentially…
  • Abstract Number: 207 • 2019 ACR/ARP Annual Meeting

    Effects of Successive Switches to Different Biosimilars Infliximab on Immunogenicity in Chronic Inflammatory Diseases in Daily Clinical Practice

    Ambre Lauret 1, Anna Moltó 1, Vered Abitbol 2, Loriane Guterlann 3, Ornella Conort 3, Francois Chast 3, Claire Goulvestre 4, Claire Le Jeunne 5, Stanislas Chaussade 2, Christian Roux 1, Frédéric Batteux 6, Maxime Dougados 7, Yannick Allanore 1 and Jerome Avouac1, 1Paris Descartes University, Cochin Hospital, Rheumatology department, Paris, France, 2Paris Descartes University, Cochin Hospital, Gastroenterology department, Paris, France, 3Paris Descartes University, Cochin Hospital, Department of Pharmacy, paris, France, 4Paris Descartes University, Cochin Hospital, Immunology Laboratory, Paris, France, 5Paris Descartes University, Cochin Hospital, Internal Medicine department, Paris, France, 6Paris Descartes University, Cochin Hospital, Immunology Laborator, Paris, France, 7Cochin Hospital, Paris, France

    Background/Purpose: To determine whether the successive switches from innovator infliximab to a first then a second biosimilar infliximab, or from a first to a second…
  • Abstract Number: 251 • 2019 ACR/ARP Annual Meeting

    Long-term Financial Impact of Switching from Reference to Biosimilar Etanercept When Considering Short-term Formulary Management Costs in the US

    Dylan Mezzio 1, Edward Li2 and Sanjeev Balu 3, 1Xcenda, Pleasant Hill, CA, 2Sandoz Inc., Princeton, NJ, 3Sandoz Inc, Princeton, NJ

    Background/Purpose: Biosimilars have enabled some US institutions and payers to achieve significant financial savings after implementing a formulary change from the reference biologic. However, within…
  • Abstract Number: 310 • 2019 ACR/ARP Annual Meeting

    Efficacy, Immunogenicity and Cost Analysis of a Systematic Switch from Originator Infliximab to Biossimilar CT-P13 of All Patients with Inflamatory Arthritis from a Single Center

    Ana Valido1, Joana Silva-Dinis 2, Maria João Saavedra 1, Inês Iria 3, João Gonçalves 3, João Cruz 4, Nuno Bernardo 5 and João Eurico Fonseca 2, 1Serviço de Reumatologia e Doenças Ósseas Metabólicas, Hospital de Santa Maria, CHLN; Lisboa, Portugal., Lisbon, Portugal, 2Rheumatology and Bone Diseases Department, Hospital de Santa Maria, Centro Hospitalar Universitário Lisboa Norte; Unidade de Investigação em Reumatologia, Instituto de Medicina Molecular, Faculdade de Medicina, Universidade de Lisboa; Centro Académico de Medicina de Lisboa; Lisbon, Portugal., Lisbon, Portugal, 3Faculdade de Farmácia da Universidade de Lisboa; Portugal, Lisbon, Portugal, 4Associate Professor with Habilitation, Faculdade de Farmácia da Universidade de Lisboa, Portugal, Lisbon, Portugal, 5Unidade de Negociação – Serviço de Gestão de Compras, Hospital Santa Maria, CHLN, Lisboa, Portugal., Lisbon, Portugal

    Background/Purpose: Biotechnological drugs are a fundamental resource for the treatment (Tx) of rheumatic patients (Pts). Biosimilar drugs are intended to be as effective as the…
  • Abstract Number: 514 • 2019 ACR/ARP Annual Meeting

    A Pooled Analysis of 1-year Clinical Outcomes Among 6-month Responders and Non-responders from Three Randomized Controlled Studies of TNF Inhibitor Biosimilars in Patients with Rheumatoid Arthritis

    Josef Smolen1, Michael Weinblatt 2, Paul Emery 3, Jung Yoon Choe 4, Jonathan Kay 5, Jieun Lee 6, Gihyun Myung 6, Hyoryeong Seo 6 and Jeehoon Ghil 6, 1Medical University of Vienna, Vienna, Austria, 2Brigham and Women's Hospital, Boston, MA, 3Leeds Institute of Rheumatic and Musculoskeletal Medicine, Leeds, United Kingdom, 4Division of Rheumatology, Daegu Catholic University Medical Center, Daegu, Republic of Korea, 5UMass Memorial Medical Center and University of Massachusetts Medical School, Worcester, MA, 6Samsung Bioepis Co., Ltd., Incheon, Republic of Korea

    Background/Purpose: SB4, SB2, and SB5 are biosimilars of etanercept, infliximab, and adalimumab. Phase III randomized, double-blind studies were conducted to compare efficacy and safety between…
  • Abstract Number: 519 • 2019 ACR/ARP Annual Meeting

    Efficacy of Biosimilar Candidate ABP 710 in a Phase 3 Study in Subjects with Moderate to Severe RA: Additional Analysis Focusing on the ACR Individual Components

    Mark Genovese1, Juan Sanchez-Burson 2, Éva Balázs 3, Andrea Everding 4, MyungShin Oh 5, Gary Fanjiang 5 and Stanley Cohen 6, 1Stanford University, Stanford, CA, 2Hospital Infanta Luisa, Sevilla, Spain, 3Dr. Bugyi István Hospital, Szentes, Hungary, 4HRF Hamburger Rheuma Forschungszentrum, Hamburg, Germany, 5Amgen, Thousand Oaks, CA, 6Metroplex Clinical Research Center, Dallas, TX

    Background/Purpose: ABP 710 is being developed as a biosimilar to infliximab. Both ABP 710 and infliximab reference product (RP) inhibit tumor necrosis factor-alpha. Following demonstration…
  • Abstract Number: 536 • 2019 ACR/ARP Annual Meeting

    PERFUSE: A French Prospective/Retrospective Non-interventional Cohort Study of Infliximab-naïve and Transitioned Patients Receiving Infliximab Biosimilar SB2; An Interim Analysis

    Bruno Fautrel1, Yoram Bouhnik 2, Guillaume Desjeux 3, Ulrich Freudensprung 4, Janet Addison 5 and Amira Brigui 6, 1Pitié-Salpêtrière Hospital, Department of Rheumatology, AP-HP, Sorbonne University, UPMC university, Paris, Ile-de-France, France, 2Beaujon Hospital, Department of Gastroenterology, AP-HP, Paris Diderot University, Clichy, France, 3E-health Services Sanoïa, Digital CRO, Gémenos, France, 4Biogen International GmbH, Zug, Switzerland, 5Biogen UK, Maidenhead, United Kingdom, 6Biogen France SAS, Paris, France

    Background/Purpose: SB2 is approved in the EU as an infliximab (IFX) biosimilar, having demonstrated bioequivalence and similar efficacy, safety and immunogenicity as the reference. There…
  • Abstract Number: 540 • 2019 ACR/ARP Annual Meeting

    Comparing Real-world Retention Rates in a Matched Cohort of Rheumatoid Arthritis Patients Who Either Remained on the Etanercept Originator or Switched to a Biosimilar

    Lisa Baganz1, Anja Strangfeld 2, Peter Herzer 3, Andreas Krause 4, Hans-Peter Tony 5 and Angela Zink 6, 1German Rheumatism Research Center, Berlin, Germany, 2German Rheumatism Research Center (DRFZ), Berlin, Germany, 3Scientific Advisory Board, München, Germany, 4Immanuel Krankenhaus, Berlin, Germany, 5Department of Rheumatology/Clinical Immunology, University Hospital, Wuerzburg, Germany, Würzburg, Germany, 6German Rheumatism Research Centre and Charité University medicine, Berlin, Germany

    Background/Purpose: In Germany, the first etanercept biosimilar was licensed in 2016. In contrast to other European countries there is no uniform recommendation for the prescription…
  • Abstract Number: 541 • 2019 ACR/ARP Annual Meeting

    Multicenter, Evaluator-blinded, Randomized, Non-inferiority Study, to Assess the Efficacy, Safety and Immunogenicity of Etanercept Biosimilar (EtaBS) vs. Reference Etanercept (EtaRef) in Combination with Methotrexate for the Treatment of Patients with Rheumatoid Arthritis

    Ingrid Strusberg1, Daniel Siri 2, Maria Correa 3, Santiago Scarafia 4, Rodolfo Pardo Hidalgo 5, Alberto Spindler 6, Patricio Tate 7, Horacio Venarotti 8, Jorge Velasco Zamora 9, Gustavo Citera 10, Eduardo Mysler 11, Ezequiel Klimovsky 12, Andrea Federico 12, Gabriela Eizikovits 12, Lucas Cordeiro 13 and Nestor Lago 13, 1Instituto Strusberg, Córdoba, Argentina, 2Paediatric Rheumatology International Trials Organisation (PRINTO), Genoa, Italy, 3Consultorios Reumatológicos Pampa, Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, 4Hospital Municipal "San Cayetano", Buenos Aires, Buenos Aires, Argentina, 5CER San Juan, San Juan, Argentina, 6Centro Médico Privado de Reumatología, Tucumán, Argentina, 7OMI Centro Médico, Buenos Aires, Argentina, 8Atención Integral en Reumatología – AIR, Buenos Aires, Argentina, 9Instituto Médico CER, Quilmes, Argentina, 10Instituto de Rehabilitación Psicofísica, Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, 11Organización Médica de Investigación, Buenos Aires, Argentina, 12QUID Quality In Drugs SRL, BUENOS AIRES, Argentina, 13Gema Biotech SAU, Buenos Aires, Argentina

    Background/Purpose: Enerceptan® (EtaBS) has been developed as a proposed biosimilar of etanercept. Phase I study demonstrated pharmacokinetic equivalence with EtaRef.Methods: A multicenter, non-inferiority, randomized, assessor -blinded,…
  • Abstract Number: 542 • 2019 ACR/ARP Annual Meeting

    ‘BENEFIT’ Pan-European Observational Study to Evaluate the Real-world Effectiveness of SB4 Transition from Originator Etanercept (ETN) in Patients with Rheumatoid Arthritis or Axial Spondyloarthritis: A Switch Success Story

    Carlo Selmi 1, Klaus Krüger2, Alain Cantagrel 3, Abad Hernández 4, Ulrich Freudensprung 5, Mourad Farouk Rezk 5 and Janet Addison 6, 1Humanitas Research Hospital, University of Milan, Milan, Italy, 2Medical Centre of Rheumatology, Munich, Germany, 3Center of Rheumatology of CHU, Toulouse, France, 4FEA Reumatología, Hospital Virgen del Puerto, Cáceres, Spain, 5Biogen International GmbH, Zug, Switzerland, 6Biogen UK, Maidenhead, United Kingdom

    Background/Purpose: SB4, a biosimilar to the reference ETN, received EU marketing authorisation in January 2016, based on the totality of evidence from pre-clinical and clinical…
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