Abstracts tagged "biosimilars"

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: 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: 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. Hyrich^1,2, 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 Matsuno^1,2, Masato Tomomitsu³, Atsushi Hagino³, Seonghye Shin⁴, Jiyoon Lee⁴ and Yeong Wook Song^5,6, 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…
Abstract Number: 2461 • 2017 ACR/ARHP Annual Meeting
Rituximab Is Effective in the Treatment of Rheumatoid Arthritis Irrespective of Body Mass Index; Up to 48 Weeks Results from Phase 3 Study
Dae-Hyun Yoo¹, Won Park², Chang-Hee Suh³, Seung-Cheol Shim⁴, Sang-Joon Lee⁵, Yun Ju Bae⁵, Chan Park⁵ and Noo Ri Han⁵, ¹Department of Rheumatology, Hanyang University Hospital for Rheumatic Diseases, Seoul, Korea, Republic of (South), ²Medicine/Rheumatology, Inha University Hospital, Incheon, Korea, Republic of (South), ³Ajou University School of Medicine, Suwon, Korea, Republic of (South), ⁴Department of Internal Medicine, Chungnam National University Hospital, Daejeon, Korea, Republic of (South), ⁵CELLTRION, Inc., Incheon, Korea, Republic of (South)
Background/Purpose: High body mass index (BMI) is known to be associated with inadequate clinical response to anti-TNF agents in RA patients.1 However, there are limited…
Abstract Number: 2484 • 2017 ACR/ARHP Annual Meeting
When Etanercept Switch Fails – Clinical Considerations
Oliver Hendricks and Kim Hørslev-Petersen, King Christian X's Hospital for Rheumatic Diseases, University of Southern Denmark, Institute of Regional Health Research, Denmark, Graasten, Denmark
Background/Purpose: On January 14th 2016 EMA approved the biosimilar Etanercept (SB4, Benepali) for clinical use. A non-medical switch from originator Etanercept (ETA, Enbrel) to SB4…
Abstract Number: 2492 • 2017 ACR/ARHP Annual Meeting
The Long-Term Safety and Durability of Response of Chs-0214, a Proposed Biosimilar to Etanercept: An Open-Label Safety Extension Study
Ingrid Louw¹, Alan J. Kivitz², Tsutomu Takeuchi³, Yoshiya Tanaka⁴, Satoshi Nakashima⁵, Jennifer Hodge⁶, Hong Tang⁶, Paula O'Connor⁶ and Barbara Finck⁶, ¹Panorama Medical Centre, Cape Town, South Africa, ²Department of Rheumatology, Altoona Center for Clinical Research, Duncansville, PA, ³Keio University School of Medicine, Tokyo, Japan, ⁴School of Medicine, University of Occupational and Environmental Health, Kitakyushu, Japan, ⁵Daiichi Sankyo, Tokyo, Japan, ⁶Coherus BioSciences, Inc., Redwood City, CA
Background/Purpose: CHS-0214 is a proposed biosimilar to etanercept for the treatment of rheumatoid arthritis and other auto-immune diseases. Two randomized, double-blind studies demonstrated equivalence of…
Abstract Number: 2795 • 2017 ACR/ARHP Annual Meeting
Comparison of Switching from the Originator Rituximab to the Biosimilar Rituximab GP2013 or Re‑Treatment with the Originator Rituximab in Patients with Active Rheumatoid Arthritis: Safety and Immunogenicity Results from a Multicenter, Randomized, Double-Blind Study
Hans-Peter Tony¹, Hendrik Schulze-Koops², Klaus Krüger³, Stanley B Cohen⁴, Alan J. Kivitz⁵, Slawomir Jeka⁶, Edit Vereckei⁷, Liyi Cen⁸ and Dmitrij Kollins⁸, ¹Department of Internal Medicine 2, Rheumatology and Clinical Immunology, University Hospital Würzburg, Würzburg, Germany, ²Division of Rheumatology and Clinical Immunology, Department of Internal Medicine IV, University of Munich, Munich, Germany, ³Praxiszentrum St. Bonifatius München, München, Germany, ⁴Metroplex Clinical Research Centre, Dallas, TX, ⁵Altoona Center for Clinical Research, Duncansville, PA, ⁶2nd University Hospital, CM UMK, Department of Rheumatology and Connective Tissue Diseases,, Bydgoszcz, Poland, ⁷National Institute of Rheumatology and Physiotherapy, Budapest, Hungary, ⁸Clinical Development, Sandoz, a Novartis Division, Holzkirchen, Germany
Background/Purpose: GP2013, is a biosimilar to European Union (EU) approved reference rituximab (RTX), developed in a stepwise approach that adheres to stringent biosimilar development guidelines.…
Abstract Number: 2796 • 2017 ACR/ARHP Annual Meeting
A Randomized, Double Blind Trial over 52 Weeks to Demonstrate Bioequivalence of GP2013 and Reference Rituximab in Patients with Rheumatoid Arthritis
Josef S. Smolen¹, Stanley B Cohen², Morton Scheinberg³, Tamas Shisha⁴, Dmitrij Kollins⁴, Peijuan Zhu⁵, Liyi Cen⁴, Alan J. Kivitz⁶, Andra Rodica Balanescu⁷, Juan J. Gomez-Reino⁸ and Hans-Peter Tony⁹, ¹Medical University Vienna, Division of Rheumatology, Department of Internal Medicine III, Vienna, Austria, ²Metroplex Clinical Research Centre, Dallas, TX, ³Rheumatology, Hospital Israelita Albert Einstein, Sao Paulo, Brazil, ⁴Clinical Development, Sandoz, a Novartis Division, Holzkirchen, Germany, ⁵Clinical Pharmacology, Sandoz, a Novartis Division, NJ, NJ, ⁶Altoona Center for Clinical Research, Duncansville, PA, ⁷Research Center of Rheumatic Diseases, “Sf. Maria” Hospital, University of Medicine and Pharmacy “Carol Davila”, Bucharest, Romania, ⁸BIOBADASER, Santiago, Spain, Santiago de Compostela, Spain, ⁹Department of Internal Medicine 2, Rheumatology and Clinical Immunology, University Hospital Würzburg, Würzburg, Germany
Background/Purpose: Rituximab (RTX) is a mAB indicated for the treatment of RA in patients with inadequate response to anti-TNF therapy. The current study compares the…
Abstract Number: 455 • 2017 ACR/ARHP Annual Meeting
Analysis of Real-World Treatment Patterns in a Matched Sample of Rheumatology Patients with Continuous Infliximab Therapy or Switched to Biosimilar Infliximab
Lorie A. Ellis¹, Ismail Simsek², Lin Xie³, Adesuwa Ogbomo³, Dennis Parenti⁴, Kavitha Goyal⁴ and Yusuf Yazici⁵, ¹Janssen HECOR Immunology, Horsham, PA, ²Guven Hospital, Ankara, Turkey, ³STATinMED Research Inc., Ann Arbor, MI, ⁴Janssen Scientific Affairs, LLC, Horsham, PA, ⁵New York University School of Medicine, New York, NY
Background/Purpose: Biosimilar infliximab (CT-P13) was first approved in Europe in 2013.This study compared treatment (tx) patterns of Turkish pts with a diagnosis of rheumatoid arthritis(RA)…

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