Abstracts tagged "biosimilars"

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…
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: 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…

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