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Abstracts tagged "etanercept and rheumatoid arthritis (RA)"

  • 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: 592 • 2018 ACR/ARHP Annual Meeting

    Improved Response to Etanercept Is Associated with Serum Vitamin D Levels in Rheumatoid Arthritis

    W Dankers1, Pascal HP de Jong2, S Heil3, S van den Berg3, A Weel4, JMW Hazes5, E Colin6 and Erik Lubberts7, 1Immunology, Erasmus MC, University Medical Center, Rotterdam, Netherlands, 2Rheumatology, Maasstad Hospital, Rotterdam, Netherlands, 3Clinincal Chemistry, Erasmus MC, Rotterdam, Netherlands, 4Rheumatology, Erasmus MC, Rotterdam, Netherlands, 5Department of Rheumatology, Erasmus University Medical Center, Rotterdam, Netherlands, 6ZGT Almelo, Deventer, Netherlands, 7Erasmus Medical Center, Rheumatology, Rotterdam, Netherlands

    Background/Purpose: Although treatment of rheumatoid arthritis (RA) has significantly improved during the past decades, many patients do not adequately respond or become resistant to current…
  • Abstract Number: 2994 • 2018 ACR/ARHP Annual Meeting

    Costs Associated with Non-Medical Switching from Originator to Biosimilar Etanercept in Patients with Rheumatoid Arthritis in the UK

    Kateryna Onishchenko1, Stamatia Theodora Alexopoulos1, Cinzia Curiale2 and Miriam Tarallo2, 1Consulting at McCann Health, London, United Kingdom, 2Pfizer, Rome, Italy

    Background/Purpose: To estimate the cost impact of non-medical switching from originator etanercept (ETN) to biosimilar ETN in patients with rheumatoid arthritis (RA) in the UK.…
  • 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: 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: 2797 • 2017 ACR/ARHP Annual Meeting

    Etanercept Biosimilar GP2015 Has Equivalent Efficacy and Safety to Etanercept Originator in Patients with Moderate to Severe Rheumatoid Arthritis: The Phase 3 Equira Study

    Arthur Kavanaugh1, Yannick Allanore2, Eugeniusz J. Kucharz3 and Goran Babic4, 1Medicine, University of California, San Diego, La Jolla, CA, 2Department of Rheumatology, Cochin Hospital, Paris Descartes University, Paris, France, 3Department of Internal Medicine and Rheumatology, Medical University of Silesia, Katowice, Poland, 4Clinical development, Biopharmaceuticals, Hexal AG, a Sandoz company, Holzkirchen, Germany

    Background/Purpose: The biosimilarity of GP2015 and etanercept originator product (ETN) has been previously demonstrated in patients with chronic plaque-type psoriasis.1 The randomized, double-blind, phase 3…
  • Abstract Number: 591 • 2016 ACR/ARHP Annual Meeting

    Patient-Reported Outcomes for Etanercept Therapy in Adult Patients with Moderate to Severe Rheumatoid Arthritis Who Failed Adalimumab Treatment

    Louis Bessette1, Majed Khraishi2, Alan J Kivitz3, Arunan Kaliyaperumal4, Rama Grantab5, Melanie Poulin-Costello5, Maya Isaila5 and David Collier4, 1Rhumatology, Centre d’Ostéoporose et de Rhumatologie de Québec (CORQ), Québec, QC, Canada, 2Medical Consultants of West Newfoundland, Western Memorial Hospital, Corner Brook, NF, Canada, 3Altoona Center for Clinical Research, Duncansville, PA, 4Amgen Inc., Thousand Oaks, CA, 5Amgen Canada Inc., Mississauga, ON, Canada

    Background/Purpose: When a tumor necrosis factor inhibitor (TNFi) fails in a patient with moderate to severe rheumatoid arthritis (RA), new American College of Rheumatology (ACR)…
  • Abstract Number: 2526 • 2016 ACR/ARHP Annual Meeting

    TNF Blocker Concentrations or Detection of Antibodies Against Anti-TNF before a Tapering Process Are Not Predictive to Relapse

    Hubert Marotte1,2, Mélanie Rinaudo-Gaujous3, Stéphane Paul3,4 and Bruno Fautrel5, 1SAINBIOSE INSERM U1059 and Rheumatology department, University of Lyon and University Hospital of Saint Etienne, Saint Etienne, France, 2Rheumatology Department, University Hospital of Saint-Etienne, Saint-Etienne, France, 3Laboratory of Immunology and immunomonitoring, CIC CIE3 Inserm Vaccinology, GIMAP EA3064, Hôpital Nord, Saint-Etienne, France, 4Centre Hospitalier Universitaire de Saint-Étienne, Saint-Étienne, France, 5Rheumatology, Pitié Salpêtrière Hospital, Paris, France

    Background/Purpose:  The goal of rheumatoid arthritis (RA) strategy is to reach remission or at least a low disease activity. When this goal is reached, no…
  • Abstract Number: 2579 • 2016 ACR/ARHP Annual Meeting

    Etanercept Treatment Does Not Adversely Affect Traditional Cardiovascular Risk Factors in Patients with Rheumatoid Arthritis

    Atul A. Deodhar1, Bojena Bitman2, Yue Yang2 and David Collier3, 1Division of Arthritis & Rheumatic Diseases OP09, Oregon Health & Science University, Portland, OR, 2Amgen Inc., South San Francisco, CA, 3Amgen Inc., Thousand Oaks, CA

    Background/Purpose: Patients with rheumatoid arthritis (RA) are at increased risk of cardiovascular (CV) disease. This analysis evaluated changes in metabolic and lipid CV risk factors…
  • Abstract Number: 540 • 2015 ACR/ARHP Annual Meeting

    Clinical Relevance of Etanercept Levels and Anti-Etanercept Antibodies in Long-Term Treatment of Rheumatoid Arthritis Patients

    Susanne Drynda and Jörn Kekow, Univ of Magdeburg, Clinic of Rheumatology, Vogelsang-Gommern, Germany

    Background/Purpose: Biological compounds have belonged to the therapeutic options for the treatment of rheumatoid arthritis for about 15 years. The application of biological substances is…
  • Abstract Number: 598 • 2015 ACR/ARHP Annual Meeting

    Economic Impact of Decreasing Adalimumab and Etanercept Doses and Drug Monitoring in Patients with Rheumatoid Arthritis in Clinical Remission: Preliminary Study from a Local Biologics Unit

    José Rosas1, Francisca Llinares-Tello2, José Miguel Senabre1, Gregorio Santos-Soler1, Esteban Salas-Heredia1, Xabier Barber3, Ana Pons4, Catalina Cano4, Marisa Lorente5 and Juan Molina6, 1Rheumatology, Hospital Marina Baixa, Villajoyosa, Spain, 2Clinical Analysis, Hospital Marina Baixa, Clinical Analysis, Villajoyosa, Spain, 3Centro de Investigación Operativa, Miguel Hernández University, Elche, Spain, 4Hospital Marina Baixa, Nursing, Villajoyosa, Spain, 5Marina Baixa Hospital, Nursing, Villajoyosa, Spain, 6Hospital Marina Baixa, Clinical Analysis, Villajoyosa, Spain

    Background/Purpose: To evaluate the economic impact of adalimumab (ADL) and etanercept (ETN) dose reduction (by decreasing treatment frequency) and drug monitoring in patients with rheumatoid…
  • Abstract Number: 2739 • 2015 ACR/ARHP Annual Meeting

    Survival of Etanercept (ETN) Responders after Methotrexate (MTX) Failure When ETN Is Initiated As Mono or Combination Therapy or after MTX Withdrawal from ETN/MTX Combination in Long Standing Rheumatoid Arthritis (RA). a Single Center Retrospective Study

    Edward C. Keystone1, Abdulaziz ALKhalaf2,3, Sabri ALSaeedi4,5, Mosaab Makkawy4,6, Deborah Weber7 and Daming Lin8, 1Mount Sinai Hospital, University of Toronto, Toronto, ON, Canada, 2Rheumatology Division, Medicine Department, UNIVERSITY OF TORONTO/Mount Sinai Hospital, Toronto, ON, Canada, 3Rheumatology Division, Medicine Department, King Saud University, Riyadh, Saudi Arabia, 4Rheumatology Division, Medicine Department, UNIVERSITY OF TORONTO/ Mount Sinai Hospital, Toronto, ON, Canada, 5Rheumatology Division, Medicine Department, King Fahd Hospital, Jeddah, Saudi Arabia, 6Rheumatology Division, Medicine Department, Prince Mohammad Bin Abdulaziz Hospital, Riyadh, Saudi Arabia, 7Advanced Therapeutics, Mt Sinai Hosp 2nd Floor 02-205, Toronto, ON, Canada, 8Rheumatology, Mount Sinai Hospital, University of Toronto, Toronto, ON, Canada

    Background/Purpose: The long term sustainability of ETN as monotherapy (mono) or in combination (combo) with methotrexate (MTX) is uncertain in patients with longstanding RA  responding…
  • Abstract Number: 477 • 2015 ACR/ARHP Annual Meeting

    On-Demand Use of Etanercept Only for Disease Flares Reduced the Disease Activity Score and Structural Damage Equivalent to Fully-Use of Etanercept in RA Patients

    Kentaro Inui1, Tatsuya Koike2, Masahiro Tada3, Yuko Sugioka2, Kenji Mamoto4, Tadashi Okano4, Akira Sakawa5, Kenzo Fukushima6 and Hiroaki Nakamura4, 1Orthopaedic Surgery, Osaka City University Graduate School of Medicine, Osaka, Japan, 2Center for Senile Degenerative Disorders (CSDD), Osaka City University Graduate School of Medicine, Osaka, Japan, 3Orthopaedic Surgery, Osaka City General Hospital, OSAKA, Japan, 4Orthopedic Surgery, Osaka City University Graduate School of Medicine, Osaka, Japan, 5Orthopaedic Surgery, Osaka City Juso Hospital, Osaka, Japan, 6Orthopaedic Surgery, Fujiidera Municipal Hospital, Fujiidera, Japan

    Background/Purpose: Biological disease-modifying antirheumatic drugs (bDMARDs) are essential in the treatment of rheumatoid arthritis (RA). Biological DMARDs are particularly recommended for patients with active RA…
  • Abstract Number: 2924 • 2014 ACR/ARHP Annual Meeting

    Clinical Utility of Random Anti-TNF Drug Level Testing and Measurement of Anti-Drug Antibodies on Long-Term Treatment Response in Rheumatoid Arthritis

    Meghna Jani1, Hector Chinoy1,2, Richard B. Warren3, Christopher E.M Griffiths3, Ann W. Morgan4, Anthony G. Wilson5, Kimme L. Hyrich1, John Isaacs6, Darren Plant1,2 and Anne Barton1,7, 1Centre for Musculoskeletal Research, University of Manchester, Manchester, United Kingdom, 2NIHR Manchester Musculoskeletal Biomedical Research Unit, Manchester Academy of Health Sciences, Manchester, United Kingdom, 3Dermatology Centre, University of Manchester, Manchester, United Kingdom, 4Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, United Kingdom, 5Conway Institute of Biomolecular & Biomedical Research, University College Dublin, Dublin, Ireland, 6Institute of Cellular Medicine, University of Newcastle, Newcastle, United Kingdom, 7NIHR Manchester Musculoskeletal Biomedical Research Unit, Manchester Academic Health Science Centre, Manchester, United Kingdom

    Background/Purpose Up to 40% of RA patients on anti-TNF treatment fail to respond either due to primary inefficacy or loss of response. One explanation is…
  • Abstract Number: 2418 • 2014 ACR/ARHP Annual Meeting

    Treatment Pattern and Direct Cost of Biologics for Rheumatoid Arthritis Patients: A Real-World Analysis of Nationwide Japanese Claims Data

    Naonobu Sugiyama M.D., Ph.D1, Tatsunori Murata, M.S.2, Yosuke Morishima3, Yuri Fukuma4, Yoshiyuki Shibasaki4 and Lisa Marshall5, 1Medical Affairs, Pfizer Japan Inc. RA & Inflammation Area Medical Affairs Department, Tokyo, Japan, 2Health Economics Research Group, CRECON Research and Consulting Inc., Tokyo, Japan, 3RA & Inflammation Area Medical Affairs Department, Pfizer Japan Inc. RA & Inflammation Area Medical Affairs Department, Tokyo, Japan, 4Pfizer Japan Inc. RA & Inflammation Area Medical Affairs Department, Tokyo, Japan, 5Inflammation Immunology Disease Group, Pfizer Inc. Inflammation Immunology Disease Group, Collegeville, PA

    Background/Purpose Biologics such as etanercept (ETN), adalimumab (ADA), infliximab (IFX) and tocilizumab (TCZ) have led dramatic improvement in the treatment of rheumatoid arthritis (RA), but…
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