ACR Meeting Abstracts

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Abstracts tagged "biosimilars"

  • Abstract Number: 2515 • 2018 ACR/ARHP Annual Meeting

    Joint Damage Progression According to Disease Activity States in Patients with Rheumatoid Arthritis Treated with CT-P10 and Reference Rituximab: Up to 48 Weeks Results from Phase III Study

    Chang-Hee Suh1, Dae-Hyun Yoo2, Won Park3, Seung-Cheol Shim4, Sang-Joon Lee5, Yun Ju Bae5, Sang Eun Han5 and Sang Mi Lee5, 1Rheumatology, Ajou University School of Medicine, Suwon, Korea, Republic of (South), 2Department of Rheumatology, Hanyang University Hospital for Rheumatic Diseases, Seoul, Korea, Republic of (South), 3Medicine/Rheumatology, Inha University Hospital, Incheon, Korea, Republic of (South), 4Division of Rheumatology, Department of Internal Medicine, Daejeon Rheumatoid & Degenerative Arthritis Center, Chungnam National University Hospital, Daejeon, Korea, Republic of (South), 5CELLTRION, Inc., Incheon, Korea, Republic of (South)

    Background/Purpose: CT-P10 is a biosimilar of the reference rituximab (RTX) and has been approved by several regulatory agencies including EMA. Pharmacokinetic and therapeutic equivalence from…
  • Abstract Number: 2521 • 2018 ACR/ARHP Annual Meeting

    A Randomized, Double-Blind Phase III Study Comparing the Efficacy, Safety and Immunogenicity of PF-06438179/GP1111 (Ixifi™), an Infliximab Biosimilar, and Infliximab Reference Product (Remicade®) in Patients with Moderate to Severe Active RA: Results from Week 54 to Week 78

    Stanley Cohen1, Alan J. Kivitz2, Michael Tee3, Carol Cronenberger4, Min Zhang5, Sarah Hackley6, Karl Schumacher7 and Muhammad I. Rehman8, 1Metroplex Clinical Research Center, LLC, Dallas, TX, 2Altoona Center for Clinical Research, Duncansville, PA, 3Department of Medicine, Medical Center Manila and University of the Philippines, Manila, Philippines, 4Pfizer Inc, Collegeville, PA, 5Pfizer Inc, La Jolla, CA, 6Pfizer Ltd, Sandwich, United Kingdom, 7Global Clinical Development, Biopharmaceuticals, Sandoz Biopharmaceuticals, Holzkirchen, Germany, 8Pfizer Inc, Andover, MA

    Background/Purpose: PF-06438179/GP1111 (IFX-PF) is an infliximab (IFX) biosimilar for the treatment of immune-mediated inflammatory diseases, including RA. This randomized, double-blind, comparative clinical study evaluated the…
  • Abstract Number: 2522 • 2018 ACR/ARHP Annual Meeting

    Biosimilar BI 695501 and Adalimumab Reference Product (RP) Have Similar Efficacy and Safety in Patients (pts) with Moderately-to-Severely Active Rheumatoid Arthritis (RA): Long-Term Results from a Phase IIIb Extension Study (VOLTAIRE®-RAext)

    Stanley Cohen1, Niklas Czeloth2, Eric Lee3, Piotr A. Klimiuk4, Nuala Peter5 and Girish Jayadeva2, 1Metroplex Clinical Research Center, Dallas, TX, 2Boehringer Ingelheim, Ingelheim a.R., Germany, Ingelheim, Germany, 3Inland Rheumatology, Upland, CA, 4Medical University of Bialystok and Gabinet Internistyczno-Reumatologiczny, Bialystok, Poland, 5Boehringer Ingelheim, Biberach a.d.R., Germany, Ingelheim a.R., Germany

    Background/Purpose: Clinical equivalence of BI 695501 to the adalimumab RP has been shown in pts with moderately-to-severely active RA in the Phase III VOLTAIRE®-RA study…
  • Abstract Number: 2526 • 2018 ACR/ARHP Annual Meeting

    Revealing and Addressing Knowledge Gaps Regarding Biosimilars in Rheumatology Practice with Targeted Continuing Education and Patient Surveys

    Katie Robinson and Robert Esgro, Vindico Medical Education, Thorofare, NJ

    Background/Purpose: With the recent introduction of biosimilars in the US market, providers lack knowledge of how these agents compare to reference biologics and the implications…
  • Abstract Number: 2532 • 2018 ACR/ARHP Annual Meeting

    The Efficacy and Drug Survival of the Biosimilar Infliximab (CT–P13) Compared to the Original Reference Infliximab in Inflammatory Rheumatic Diseases; Results from the Turkbio Registry

    Sadettin Uslu1, Gerçek Can1, Soner Senel2, Ediz Dalkiliç3, Nevsun Inanc4, Servet Akar5, Sinem Burcu Kocaer1, Merih Birlik1, Sedat Capar6, Nurullah Akkoc7 and Fatos Onen1, 1Rheumatology, Dokuz Eylul University Faculty of Medicine, İzmir, Turkey, 2Rheumatology, Kayseri Erciyes University, Faculty of Medicine, Kayseri, Turkey, 3Rheumatology, Uludag University Faculty of Medicine, Bursa, Turkey, 4Rheumatology, Marmara University, School of Medicine, Istanbul, Turkey, 5Rheumatology, Izmir Katip Celebi University, School of Medicine, Rheumatology, Izmir, Turkey, 6Dokuz Eylül University Faculty of Statistics, Izmir, Turkey, 7Rheumatology, İzmir, Turkey, İzmir, Turkey

    Background/Purpose: Biosimilar infliximab (CT-P13) has been used to treat patients with rheumatoid arthritis (RA), ankylosing spondylitis (AS) and psoriatic arthritis (PsA) in Turkey since 2013.The…
  • Abstract Number: 1549 • 2017 ACR/ARHP Annual Meeting

    A Non-Medical Switch from Originator Infliximab to Biosimilar CT-P13 in 36 Patients with Ankylosing Spondylitis:  6 – Months Clinical Outcomes from the Czech Biologic Registry Attra

    Šárka Forejtová1, Jakub Zavada1, Lenka Szczukova2, Katerina Jarosova1, Tom Philipp3 and Karel Pavelka4, 1Institute of Rheumatology and Department of Rheumatology, 1st Faculty of Medicine, Charles University, Czech Republic, Prague, Czech Republic, 2Institute of Biostatistics and Analyses, Faculty of Medicine, Masaryk University, Brno, Brno, Czech Republic, 3Department of Rheumatology and Physiotherapy, Thomayer Hospital, Prague, Praha 4, Czech Republic, 4Institute of Rheumatology, Prague, Czech Republic, Prague, Czech Republic

    Background/Purpose: A non-medical switch from originator (INX, Remicade) to biosimilar infliximab (CT-P13, Remsima) was conducted in 36 patients with ankylosing spondylitis (AS) in one clinical…
  • Abstract Number: 2800 • 2017 ACR/ARHP Annual Meeting

    Long-Term Safety and Efficacy of Biosimilar Infliximab (CT-P13) after Switching from Originator Infliximab: Results from the 26-Week Open Label Extension of a Randomized Norwegian Trial

    Guro Løvik Goll1, Kristin Kaasen Jørgensen2, Joe Sexton1, Inge C Olsen3, Nils Bolstad4, Merete Lorentzen5, Espen A. Haavardsholm6, Cato Mork7, Jorgen Jahnsen8 and Tore K Kvien9, 1Dept Rheumatology, Diakonhjemmet Hospital, Oslo, Norway, 2Dept Gastroenterology, Akershus University Hospital, Lørenskog, Norway, 3Department of Rheumatology, Diakonhjemmet Hospital, Oslo, Norway, 4Department of Medical Biochemistry,, OUS-Radiumhospitalet, Oslo, Norway, 5Dept of Dermatology, Rikshospitalet, Oslo, Norway, 6Dept. of Rheumatology, Diakonhjemmet Hospital, Oslo, Norway, 7Dept of cancer and Molecular medicine, Norwegian University of Science and Technology, Trondheim, Norway, 8Dept of Gastroenterology, Akershus University Hospital, Lorenskog, Norway, 9Diakonhjemmet Hospital, Oslo, Norway

    Background/Purpose: TNF-inhibitors (TNFi) have improved treatment of rheumatoid arthritis (RA), spondyloarthritis (SpA), psoriatic arthritis (PsA) , Crohn’s disease (CD), ulcerative colitis (UC), and chronic plaque…
  • Abstract Number: 1550 • 2017 ACR/ARHP Annual Meeting

    One-Year Clinical Outcomes in 1623 Patients with Inflammatory Arthritis Who Switched from Originator to Biosimilar Etanercept – an Observational Study from the Danish Danbio Registry

    Bente Glintborg1, Emina Omerovic1, Kamilla Danebod1, Dorte Vendelbo Jensen1, Henrik Nordin1, Anne Gitte Loft1, Stavros Chrysidis1, Johnny Lillelund Raun1, Oliver Hendricks1, Hanne Lindegaard1, Jakob Espesen1, Susanne Jakobsen1, Inger Marie J. Hansen1, Jolanta Grydehøj1, Emil Dalgaard1, Dorte Dalsgaard Pedersen1, Natalia Manilo2, Lis Smedegaard Andersen3, Salome Kristensen1, Asta Linauskas1, Niels Steen Krogh4 and Merete Lund Hetland5, 1The DANBIO registry and the Danish Departments of Rheumatology, Copenhagen, Denmark, 2Center for Rheumatology and Spine Diseases, Copenhagen University Hospital Frederiksberg, Copenhagen, Denmark, 3Department of Rheumatology, The DANBIO registry and the Danish Departments of Rheumatology, Copenhagen, Denmark, 4The DANBIO Registry, Copenhagen Center for Arthritis Research, Center for Rheumatology and Spine Diseases, Rigshospitalet, Copenhagen, Denmark, 5The DANBIO registry and the Danish Departments of Rheumatology, Glostrup, Denmark

    Background/Purpose: According to Danish national guidelines issued in April 2016, a non-medical switch from originator (ETA, Enbrel) to biosimilar Etanercept (SB4, Benepali) (50 mg s.c.)…
  • Abstract Number: 2879 • 2017 ACR/ARHP Annual Meeting

    Switching from Adalimumab to Chs-1420: A Randomized, Double-Blind Global Clinical Trial in Patients with Psoriasis and Psoriatic Arthritis

    Jennifer Hodge, Hong Tang, Paula O'Connor and Barbara Finck, Coherus BioSciences, Inc., Redwood City, CA

    Background/Purpose: CHS-1420 is a proposed biosimilar to adalimumab. A phase 3, randomized, double-blind, multicenter study evaluated the equivalence of CHS-1420 to adalimumab in patients with…
  • Abstract Number: 2260 • 2017 ACR/ARHP Annual Meeting

    Communication Strategies Are Highly Important to Avoid Nocebo Effect When Performing Non-Medical Switch from Originator Product to Biosimilar Product: Danish Results from Applying the Parker Model a Qualitative 3-Step Research Model

    Tanja Schjødt Jørgensen1, Marie Skougaard1, Hans Christian Asmussen2,3, Anne Lee4, Peter C. Taylor5, Henrik Gudbergsen1 and Lars Erik Kristensen1, 1The Parker Institute, Copenhagen University Hospital, Bispebjerg and Frederiksberg, Copenhagen F, Denmark, 2NATiON, Copenhagen, Denmark, 3Communication IKH, Roskilde University, Roskilde, Denmark, 4University of Southern Denmark, Odense, Denmark, 5University of Oxford Botnar Research Centre, Kennedy Institute of Rheumatology, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, Oxford, United Kingdom

    Background/Purpose: Introducing a non-medical switch from originator to a biosimilar product in the management of chronic arthritis, i.e. switching patients in remission or low disease…
  • Abstract Number: 2438 • 2017 ACR/ARHP Annual Meeting

    Open Label Transitioning from Originator Etanercept to Biosimilar SB4 Compared to Continuing Treatment with Originator Etanercept in a Historical Cohort in Rheumatic Diseases in Daily Practice

    L. Tweehuysen1, V.J.B. Huiskes2, B.J.F. Van den Bemt (PharmD, PhD)3, S. Teerenstra4, F.H.J. van den Hoogen5, C.H.M. van den Ende5 and A.A. Den Broeder5, 1Rheumatology, Sint Maartenskliniek, Nijmegen, Netherlands, 2Pharmacy, Sint Maartenskliniek, Nijmegen, Netherlands, 3Pharmacy, Sint Maartenskliniek and Radboudumc, Nijmegen, Netherlands, 4Biostatistics, Radboudumc, Nijmegen, Netherlands, 5Rheumatology, Sint Maartenskliniek and Radboudumc, Nijmegen, Netherlands

    Background/Purpose: Blinded transitioning from originator infliximab (INX) to biosimilar CT-P13 was not inferior to continuing INX treatment.1 Open label mandatory transitioning resulted in a  slightly…
  • Abstract Number: 2439 • 2017 ACR/ARHP Annual Meeting

    Switching from RA Originator to Biosimilar in Routine Clinical Care:  Early Data from the British Society for Rheumatology Biologics Register for Rheumatoid Arthritis

    Diederik De Cock1, Lianne Kearsley-Fleet1, Kath Watson1 and Kimme L. Hyrich1,2, 1Arthritis Research UK Centre for Epidemiology, University of Manchester, Manchester Academic Health Science Centre, Manchester, United Kingdom, 2National Institute of Health Research Manchester Musculoskeletal Biomedical Research Centre, Central Manchester NHS Foundation Trust, Manchester Academic Health Science Centre, Manchester, United Kingdom

    Background/Purpose: Biosimilars, biopharmaceuticals assessed by regulatory agencies to have efficacy and safety similar to their reference products, were introduced to the UK market in February…
  • Abstract Number: 2441 • 2017 ACR/ARHP Annual Meeting

    A Phase III, Multicenter, Double-Blind, Randomized, Parallel-Group Study to Evaluate the Similarities between LBEC0101 and Etanercept Reference Product in Terms of Efficacy and Safety in Patients with Active Rheumatoid Arthritis Inadequately Responding to Methotrexate

    Hiroaki Matsuno1,2, Masato Tomomitsu3, Atsushi Hagino3, Seonghye Shin4, Jiyoon Lee4 and Yeong Wook Song5,6, 1Matsuno Clinic for Rheumatic Diseases, Toyama, Japan, 2Institute of Medical Science, Tokyo Medical University, Tokyo, Japan, 3Mochida Pharmaceutical Co.,Ltd., Tokyo, Japan, 4Clinical Development, LG Chem, Ltd., Seoul, Korea, Republic of (South), 5Department of Molecular Medicine and Biopharmaceutical Sciences, Graduate School of Convergence Science and Technology, and College of Medicine, Seoul National University, Seoul, Korea, Republic of (South), 6Department of Molecular Medicine and Biopharmaceutical Sciences, Graduate School of Convergence Science and Technology, and College of Medicine, Medical Research Center, Seoul National University, Seoul, Korea, Republic of (South)

    Background/Purpose: LBEC0101 has been developed as a biosimilar to the etanercept reference product (ETN-RP). This study was to evaluate the similarities between LBEC0101 and ETN-RP…
  • Abstract Number: 2445 • 2017 ACR/ARHP Annual Meeting

    Efficacy and Safety of Rituximab Biosimilar, CT-P10, after a Single Switch from Innovator Rituximabs in Patients with Rheumatoid Arthritis: Results from Phase 3 Randomized Controlled Trial over 72 Weeks

    Seung-Cheol Shim1, Ljubinka Bozic Majstorovic2, Alfredo Berrocal Kasay3, Elias Chalouhi El-Khouri4, Fedra Irazoque-Palazuelos5, Francisco Cons Molina6, Francisco G. Medina-Rodriguez7, Pedro Miranda8, Pavel Shesternya9, Jose Chavez Corrales10, Piotr Wiland11, Slawomir Jeka12, Olena Garmish13, Pawel Hrycaj14, Natalia Fomina15, Won Park16, Chang-Hee Suh17, Sang-Joon Lee18, Sung Young Lee19 and Dae-Hyun Yoo20, 1Department of Internal Medicine, Chungnam National University Hospital, Daejeon, Korea, Republic of (South), 2Clinical Centre Banja Luka, Bonja Luka, Bosnia and Herzegovina, 3ABK Reuma SRL – Medicentro Biociencias, Lima, Peru, 4Clinica Internacional, Lima, Peru, 5Centro de Invstigacion y Tratamiento Reumatologico S.C, Mexico City, Mexico, 6Centro de Investigacion en Artritis y Osteoporosis, Mexicali, Mexico, 7Rheumatology, LaSalle University, Mexico City, Mexico, 8Centro De Estudios Reumatológicos, Santiago, Chile, 9Rheumatology Department, Krasnoyarsk State Medical University, Krasnoyarsk, Russia, 10Clinica San Borja, Lima, Peru, 11Department and Clinic of Rheumatology and Internal Medicine, Medical University, Wroclaw, Poland, 122nd University Hospital, CM UMK, Department of Rheumatology and Connective Tissue Diseases,, Bydgoszcz, Poland, 13Institute of Cardiology named by M.D. Strazhesko NAMS of Ukraine, Kyiv, Ukraine, 14Department of Rheumatology and Clinical Immunology, Poznan University of Medical Sciences, Poznan, Poland, 15Kemerovo Regional Clinical Hospital, Kemerovo, Russian Federation, 16Medicine/Rheumatology, Inha University Hospital, Incheon, Korea, Republic of (South), 17Ajou University School of Medicine, Suwon, Korea, Republic of (South), 18CELLTRION, Inc., Incheon, Korea, Republic of (South), 19Clinical Planning Department, CELLTRION, Inc., Incheon, Korea, Republic of (South), 20Department of Rheumatology, Hanyang University Hospital for Rheumatic Diseases, Seoul, Korea, Republic of (South)

    Background/Purpose: Similarity of pharmacokinetic, efficacy and safety between CT-P10 and reference rituximab (RTX) were shown in the phase 3 randomized controlled trial (NCT02149121) up to…
  • Abstract Number: 2447 • 2017 ACR/ARHP Annual Meeting

    Effectiveness and Tolerability of Benepali in Rheumatoid Arthritis Patients Switched from Enbrel

    Sarah Dyball1, Victoria Hoskins2, Sharon Christy-Kilner2 and Sahena Haque3, 1Rheumatology, University Hospitals of South Manchester NHS Foundation Trust, Manchester, United Kingdom, 2University Hospitals of South Manchester NHS Foundation Trust, Manchester, United Kingdom, 3Rheumatology department, University Hospitals of South Manchester NHS Foundation Trust, Manchester, United Kingdom

    Background/Purpose: Benepali, the etanercept biosimilar, is licenced in the UK for rheumatoid arthritis (RA) and costs less than Enbrel. This study aimed to evaluate the…
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