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  • Abstract Number: 539 • 2019 ACR/ARP Annual Meeting

    A Randomized Double-Blind Study Comparing Pharmacokinetics (PK) and Pharmacodynamics (PD) of ABP 798 with Rituximab in Subjects with Moderate to Severe RA

    Gerd Burmester1, Stanley Cohen 2, David Chien 3, Vincent Chow 3 and Zhiying Pan 3, 1Charité—University Medicine Berlin, Berlin, Germany, 2Metroplex Clinical Research Center, Dallas, TX, 3Amgen, Thousand Oaks, CA

    Background/Purpose: ABP 798 is being developed as a biosimilar to rituximab, a CD20-directed cytolytic antibody that is approved in the US and EU for treatment…
  • 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…
  • Abstract Number: 543 • 2019 ACR/ARP Annual Meeting

    Cytokine Signaling Pathways Inhibited by Different Biologics in Rheumatoid Arthritis Patients

    Sergio Duran-Barragan1, Efrain Chavarria-Avila 1, Marisol Esesarte-Rodriguez 1, Rosal Valenzuela-Marrufo 1, Karla Arrona-Ríos 1, Jorge Aguilar-Arreola 1, Oscar Pizano Martínez 1 and Monica Vazquez-del Mercado 1, 1Universidad de Guadalajara, Guadalajara, Jalisco, Mexico

    Background/Purpose: Different types of cells play pathogenic roles in Rheumatoid Arthritis (RA). The immunogenetics of RA suggests a key role of aberrant pathways of T…
  • Abstract Number: 544 • 2019 ACR/ARP Annual Meeting

    Tolerance, Survival, and Adherence to Methotrexate Treatment in Patients with Rheumatoid Arthritis

    Juan Sevillano1, Dafne Capelusnik 2, Emilce Schneeberger 3 and Gustavo Citera 4, 1Instituto de Rehablitacion Psicofisica, Ciudad Autonoma de Buenos Aires, Ciudad Autonoma de Buenos Aires, Argentina, 2Instituto de Rehabilitacion Psicofisica, CABA, Ciudad Autonoma de Buenos Aires, Argentina, 3Instituto de Rehabilitación Psicofísica, Buenos Aires, Argentina, 4Instituto de Rehabilitación Psicofísica, Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina

    Background/Purpose: Methotrexate (MTX) is the most frequently used medication in patients with Rheumatoid Arthritis (RA). However, several authors have questioned its success due to the…
  • Abstract Number: 545 • 2019 ACR/ARP Annual Meeting

    Molecular Analysis of the Mode of Action of Upadacitinib in Rheumatoid Arthritis Patients: Whole Blood RNA Expression Data from the SELECT-NEXT Study

    Samantha Lent 1, Thierry Sornasse 2, Robert Georgantas 1, Jeremy Sokolove 2 and Iain McInnes3, 1AbbVie, Inc., North Chicago, IL, 2AbbVie Immunology Clinical Development, Redwood City, 3Institute of Infection, Immunity & Inflammation, University of Glasgow, Glasgow, United Kingdom

    Background/Purpose: Upadacitinib (UPA), an oral JAK inhibitor selective for JAK1, demonstrated efficacy in patients with moderate-to-severe rheumatoid arthritis (RA) with an inadequate response to conventional…
  • Abstract Number: 546 • 2019 ACR/ARP Annual Meeting

    Change in Rheumatoid Arthritis (RA)-Related Autoantibody Profile and Risk of Disease Flare After Withdrawal of Therapy in Patients with Early RA Treated with Abatacept and MTX

    René Toes1, Thomas Lehman 2, Joshua Bryson 3, Amy Min Kim 2, Sandhya Balachandar 2, Sumanta Mukherjee 2, Michael Maldonado 2, Sean Connolly 2 and Thomas Huizinga 1, 1Leiden University Medical Center, Leiden, Netherlands, 2Bristol-Myers Squibb, Princeton, NJ, 3Bristol-Myers Squibb, Princeton

    Background/Purpose: An emerging concept of “immunologic remission” in RA raises questions about the relevance of the RA autoantibody profile in patients (pts) who are otherwise…
  • Abstract Number: 547 • 2019 ACR/ARP Annual Meeting

    Inhibition of Structural Joint Damage with Upadacitinib as Monotherapy or in Combination with Methotrexate in Patients with Rheumatoid Arthritis

    Charles Peterfy1, Mark Genovese 2, In-Ho Song 3, Alan Friedman 4, Stephen Hall 5, Eduardo Mysler 6, Patrick Durez 7, Xenofon Baraliakos 8, Jose Jeffrey Enejosa 9, Tim Shaw 4, Yihan Li 9, Su Chen 4 and Vibeke Strand 10, 1Spire Sciences Inc, Boca Raton, 2Stanford University, Stanford, CA, 3AbbVie Inc., North Chicago, IL, USA, North Chicago, IL, 4AbbVie Inc., North Chicago, 5Monash University and Emeritus Research, Melbourne, Australia, 6Organización Medica de Investigación, Buenos Aires, Argentina, Buenos Aires, Argentina, 7Pôle de Recherche en Rhumatologie, Institut de Recherche Expérimentale et Clinique, UCL Saint-Luc, Brussels, Belgium, 8Rheumatology Department, Rheumazentrum Ruhrgebiet Herne, Ruhr-University Bochum, Bochum, Germany, 9AbbVie Inc., North Chicago, IL, 10Division of Immunology/Rheumatology, Stanford University, Stanford, CA

    Background/Purpose: Long­‑term prevention of structural joint damage is a key treatment goal in the management of RA1. Upadacitinib (UPA), a JAK1-selective inhibitor, inhibited the progression…
  • Abstract Number: 548 • 2019 ACR/ARP Annual Meeting

    Efficacy and Safety of a Novel Subcutaneous Formulation of CT-P13 over the 1-year Treatment Period and After Switching from Intravenous CT-P13 in Patients with Active Rheumatoid Arthritis: Results from Part 2 of Phase I/III Randomized Controlled Trial

    Rene Westhovens1, Piotr Wiland 2, Marek Zawadzki 3, Delina Ivanova 4, Alfredo Berrocal 5, Elias Chalouhi 6, Éva Balázs 7, Sergii Shevchuk 8, Larisa Eliseeva 9, Mykola Stanislavchuk 10, Roman Yatsyshyn 11, SangJoon Lee 12, SungHyun Kim 12, NooRi Han 13, YooBin Jung 13 and DaeHyun Yoo 14, 1University Hospitals, Leuven, Belgium, 2Medical Univeristy, Dpt of Rheumatology , Wroclaw, Wroclaw, Poland, 3Medical Univeristy, Dpt of Rheumatology, Wroclaw, Wroclaw, Poland, 4Diagnostic-Consultative Center Aleksandrovska EOOD, Sofia, Bulgaria, 5Cayetano Heredia University, Lima, Peru, 6Clinica Internacional Sede Lima, Lima, Peru, 7Dr. Bugyi István Hospital, Szentes, Hungary, 8Clinic of SRI of Invalid Rehab. (ESTC) of VNMU n.a. M.I.Pyrohov, Vinnytsia, Ukraine, 9Siberian State Medical University of Roszdrav, Tomsk, Russia, 10National Pirogov Memorial Medical University, Vinnytsya, Vinnytsia, Ukraine, 11Ivano-Frankivsk National Medical University, Ivano-Frankivsk, Ukraine, 12Celltrion Inc., Incheon, Republic of Korea, 13Celltrion, Inc., Incheon, Republic of Korea, 14Hanyang University Hospital for Rheumatic Diseases, Seoul, Republic of Korea

    Background/Purpose: Efficacy and safety of a new subcutaneous (SC) formulation (CT-P13 SC) were evaluated up to Week 30. The phase I/III randomized controlled trial in…
  • 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: 550 • 2019 ACR/ARP Annual Meeting

    Rheumatoid Arthritis Treatment with Filgotinib: Week 156 Safety and Efficacy Data from a Phase 2b Open-Label Extension Study

    Arthur Kavanaugh1, Rene Westhovens 2, Kevin Winthrop 3, Susan Lee 4, Joy Greer 4, Adam DeZure 4, Di An 4, Lei Ye 4, John Sundy 4, Robin Besuyen 5, Luc Meuleners 5, Rieke Alten 6 and Mark Genovese 7, 1University of California, San Diego School of Medicine, La Jolla, CA, 2University Hospitals, Leuven, Belgium, 3Oregon Health and Science University, Portland, OR, 4Gilead Sciences, Inc., Foster City, CA, 5Galapagos NV, Mechelen, Belgium, 6Schlosspark-Klinik University Medicine, Berlin, Germany, 7Stanford University, Stanford, CA

    Background/Purpose: Filgotinib (FIL) is an oral selective Janus kinase (JAK1) inhibitor. In studies to date, FIL has been shown to be effective and safe in…
  • Abstract Number: 551 • 2019 ACR/ARP Annual Meeting

    Upadacitinib Treatment and the Routine Assessment of Patient Index Data 3 (RAPID3) Among Patients with Rheumatoid Arthritis

    Martin Bergman1, Yoshiya Tanaka 2, Gustavo Citera 3, Sami Bahlas 4, Mira Ali 5, Sebastian Meerwein 6, Yanna Song 7 and Vibeke Strand 8, 1Drexel University College of Medicine, Stockholm, Sweden, 2University of Occupational and Environmental Health Japan, Kitakyushu, Japan, 3Instituto de Rehabilitación Psicofísica, Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, 4Medicine, King Abdulaziz University, Jeddah, Saudi Arabia, Jeddah, Saudi Arabia, 5AbbVie Inc., North Chicago, IL, USA, North Chiacgo, 6AbbVie GmbH Co. KG, Ludwigshafen, Germany, Wiesbaden, Germany, 7AbbVie Inc., North Chicago, IL, USA, North Chicago, 8Division of Immunology/Rheumatology, Stanford University, Stanford, CA

    Background/Purpose: Upadacitinib (UPA) is an oral reversible JAK inhibitor engineered for greater selectivity for JAK1 vs JAK2, JAK3, and TYK2, and is currently being assessed…
  • Abstract Number: 552 • 2019 ACR/ARP Annual Meeting

    In the Real World Clinical Setting Etanercept Biosimilar SB4(BENEPAIL®) Demonstrates Equivalent Safety and Effectiveness in Biological Naïve as Well as with ENBREL® Pretreated RA,SPA, and PSA Patients

    Herbert Kellner1, 1Praxis Prof. Herbert Kellner, Munich, Germany

    Background/Purpose: Background: Biosimilar TNFα inhibitors have only become available in the last few years. Etanercept bisosimilar SB-4 Benepali® has been launched in March 2016 in…
  • Abstract Number: 553 • 2019 ACR/ARP Annual Meeting

    Etanercept Biosimilar GP 2015 (Erelzi®) in Rheumatic Diseases: Interim Analysis of Real-World Data from COMPACT: A Multicentric, Prospective, Observational Cohort Study

    Marc Schmalzing1, Ayman Askari 2, David Walsh 3, Maria Carmen Castro 4, Francisco J. De Toro 5, Slawomir Jeka 6, Herbert Kellner 7, Hilke Friccius-Quecke 8, Fabricio Furlan 8, Sohaib Hachaichi 8 and Tom Sheeran 9, 1Universitätsklinikum Würzburg, Department of Rheumatology/ Clinical Immunology, Wuerzburg, Germany, 2Robert Jones and Agnes Hunt Orthopaedic Hospital NHS Foundation Trust, Oswestry, England, United Kingdom, 3Sherwood Forest Hospitals NHS Foundation Trust, Nottingham, United Kingdom, 4IMIBIC/Reina Sofia Hospital/University of Cordoba, Cordoba, Spain, 5University Hospital A Coruña, A Coruña, Spain, 6University Hospital Bydgoszcz no 2, CM UMK, Bydgoszcz, Poland, 7Praxis Prof. Herbert Kellner, Munich, Germany, 8Hexal AG, a Sandoz company, Holzkirchen, Germany, 9Cannock and Wolverhampton Hospitals, Staffordshire, United Kingdom

    Background/Purpose: GP2015 is an etanercept biosimilar approved for moderate to severely active rheumatoid arthritis (RA), severe active ankylosing spondylitis (AS), and active and progressive psoriatic…
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All abstracts accepted to ACR Convergence are under media embargo once the ACR has notified presenters of their abstract’s acceptance. They may be presented at other meetings or published as manuscripts after this time but should not be discussed in non-scholarly venues or outlets. The following embargo policies are strictly enforced by the ACR.

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