Abstracts Archive - Page 1951 of 2425 - ACR Meeting Abstracts

Abstract Number: 1509 • 2014 ACR/ARHP Annual Meeting
A Randomized, Double-Blind, Three-Arm, Parallel Group, Single-Dose Study to Compare the Pharmacokinetics, Safety, and Tolerability of Three Formulations of Infliximab (CT-P13, EU-sourced Infliximab and US-sourced Infliximab) in Healthy Volunteers
Dae-Hyun Yoo¹, Won Park², Seung-Cheol Shim³, Chang-Hee Suh⁴, Jihye Yun⁵ and Tina Pyo⁵, ¹Department of Rheumatology, Hanyang University Hospital for Rheumatic Diseases, Seoul, South Korea, ²Division of Rheumatology, Department of Internal Medicine, Inha University Hospital, Incheon, South Korea, ³Chungnam National University Hospital, Daejeon, South Korea, ⁴Allergy-Rheumatology, Ajou University Hospital, Suwon, South Korea, ⁵CELLTRION, Inc, Incheon, South Korea
Background/Purpose CT-P13 has been approved as the first biosimilar to innovator infliximab sourced from European Union (EU‑INX) in Sep 2013. Even if it has been…
Abstract Number: 1508 • 2014 ACR/ARHP Annual Meeting
Impact of Anti-Drug Antibody on Efficacy and Safety over Week 24 in Both CT-P10 and Innovator Rituximab Treatment Groups
Dae-Hyun Yoo¹, Won Park², Slawomir Jeka³, Fidencio Cons Molina⁴, Pawel Hrycaj⁵, Piotr Wiland⁶, Wolfgang Spieler⁷, Eun Young Lee⁸, Francisco G. Medina-Rodriguez⁹, Pavel Shesternya¹⁰, Sebastiao Radominski¹¹, Dong Hyuk Sheen¹², Mie Jin Lim¹³, Jung-Yoon Choe¹⁴, Leysan Myasoutova¹⁵, Taek Kwon¹⁶, Sang Joon Lee¹⁶, Seung-Cheol Shim¹⁷ and Chang-Hee Suh¹⁸, ¹Department of Rheumatology, Hanyang University Hospital for Rheumatic Diseases, Seoul, South Korea, ²Division of Rheumatology, Department of Internal Medicine, Inha University Hospital, Incheon, South Korea, ³University Hospital Nr 2 Dr. Jan Biziel, Collegium Medicum in Bydgoszcz, Nicolaus Copernicus University in Torun, Clinic of Rheumatology and Connective Tissue Diseases, Bydgoszcz, Poland, ⁴Centro de Investigacion en Artritis y Osteoporosis, Mexicali, Mexico, ⁵Department of Rheumatology and Clinical Immunology, Poznan University of Medical Sciences, Poznan, Poland, ⁶Department of Rheumatology, Medical University of Wroclaw, Wroclaw, Poland, ⁷Osteologie und Rheumatologie, ZeFOR GmbH Zentrum für Forschung, Zerbst, Germany, ⁸Internal Medicine, Seoul National University College of Medicine, Seoul, South Korea, ⁹Centro de Investigación Farmacológica y Biotecnológica, Mexico City, Mexico, ¹⁰Rheumatology Department, Krasnoyarsk State Medical University, Krasnoyarsk, Russia, ¹¹CETI-Centro de estudos em Terapias Inovadoras, Universidade Federal do Parana, Curitiba, Brazil, ¹²Rheumatology, Eulji University Hospital, DaeJeon, South Korea, ¹³Division of Rheumatology, Department of Internal Medicine,, Inha University Hospital, Incheon, South Korea, ¹⁴Division of Rheumatology, Catholic University of Daegu School of Medicine, Daegu, South Korea, ¹⁵City Reumatology Center, Research Medical Complex Vashe Zdorovie, Kazan, Russia, ¹⁶CELLTRION, Inc., Incheon, South Korea, ¹⁷Department of Internal Medicine, Chungnam National University Hospital, Daejeon, South Korea, ¹⁸Allergy-Rheumatology, Ajou University Hospital, Suwon, South Korea
Background/Purpose CT-P10 is a biosimilar candidate for rituximab. Pharmacokinetic equivalence and similarity of clinical efficacy, safety and immunogenicity had been demonstrated between CT-P10 and Innovator…
Abstract Number: 1507 • 2014 ACR/ARHP Annual Meeting
Patient Perspectives on the Introduction of Subsequent Entry Biologics in Canada
Suneet Sekhon¹, Raman Rai¹, Debbie McClory², Carolyn Whiskin², Melissa Deamude³, Cynthia Mech⁴, Lauri Vanstone², Alpesh Shah⁵, Arthur N. Lau⁶ and William Bensen⁷, ¹Rheumatology, Division of Rheumatology, McMaster University, Hamilton, ON, Canada, ²Rheumatology Health Team, Dr. Bensen's Rheumatology Clinic, Hamilton, ON, Canada, ³Dr William G Bensen Medicine Professional Corp, Rheumatology Health Team, Dr. Bensen's Rheumatology Clinic, Hamilton, ON, Canada, ⁴Dr. William G. Bensen, Rheumatology Health Team, Dr. Bensen's Rheumatology Clinic, Hamilton, ON, Canada, ⁵Epidemiology and Biostatistics, University of Western Ontario, MSc in Clinical Epidemiology, University of Western Ontario, London, ON, Canada, ⁶Rheumatology and Clinical Epidemiology, Division of Rheumatology, McMaster University, Hamilton, ON, Canada, ⁷Division of Rheumatology, McMaster University, Hamilton, ON, Canada
Background/Purpose: Biologic medications have revolutionized the treatment of inflammatory arthritis. Subsequent entry biologics (SEBs) or biosimilars are medications that are similar but not identical to…
Abstract Number: 1506 • 2014 ACR/ARHP Annual Meeting
Incidence of Adverse Events in Patients Treated with Intended Copies of Biologic Therapeutic Agents in Colombia and Mexico
Leonor A. Barile-Fabris¹, Fedra Irazoque-Palazuelos², Ramiro Hernández Vásquez³, Sandra Carrillo Vazquez⁴ and R. Gúzman⁵, ¹Rheumatology Department, Hospital Especialidades CMN, Mexico City, Mexico, ²Centro Médico Nacional "20 de Noviembre" ISSSTE, Mexico City, Mexico, ³Rheumatology, Hospital de Especialidades “Dr. Bernardo Sepúlveda Gutiérrez”, Mexico, Mexico, ⁴Rheumatology, Hospital Angeles Lindavista, Mexico DF, Mexico, ⁵IDEARG, SaludCoop, Bogotá, Colombia
Background/Purpose: A biosimilar is a copy of an approved biologic therapeutic agent that has undergone rigorous evaluation to ensure that it is similar to the…
Abstract Number: 1505 • 2014 ACR/ARHP Annual Meeting
The Biosimilar Landscape: A Systematic Review of Its Current Status
Niti Goel^1,2 and Kamali Chance³, ¹Rheumatology Center of Excellence, Quintiles, Durham, NC, ²Duke University Medical Center, Durham, NC, ³Global Biosimilars Unit, Quintiles, Durham, NC
Background/Purpose In the last 5 years, the number of biosimilars in development for the treatment of immunologic diseases has increased as innovator etanercept (ETA), infliximab (IFX), adalimumab…
Abstract Number: 1504 • 2014 ACR/ARHP Annual Meeting
Pharmacokinetic Equivalence of ABP 501 Relative to Adalimumab: Results from a Randomized, Single-Blind, Single-Dose, Parallel Group Study in Healthy Subjects
Primal P. Kaur¹, Vincent Chow², Nan Zhang³, Mike Moxness⁴ and Richard Markus³, ¹Amgen, Inc., Thousand Oaks, CA, ²Pharmacokinetics and Drug Metabolism, Amgen, Inc., Seattle, WA, ³Biosimilars, Amgen, Inc., Thousand Oaks, CA, ⁴Clinical Immunology and BSM, Amgen, Inc., Thousand Oaks, CA
Background/Purpose Adalimumab is a recombinant IgG1 monoclonal antibody that binds to TNFα blocking its interaction with p55 and p75 cell surface receptors. ABP 501 is…
Abstract Number: 1503 • 2014 ACR/ARHP Annual Meeting
Demonstration of Functional Similarity Comparing Adalimumab to Biosimilar Candidate ABP 501
Teresa Born¹, Jyoti Velayudhan², Yuh-fung Chen³, Heather Thomas⁴, Christina Pastula², Gwen Maher³ and Ryan Brown⁴, ¹Biosimilars Process Development, Amgen, Seattle, WA, ²Functional Biocharacterization, Amgen, Seattle, WA, ³Functional Biocharacterization, Amgen, Thousand Oaks, CA, ⁴Inflammation Research, Amgen, Seattle, WA
Background/Purpose: ABP 501 is being developed as a biosimilar to adalimumab, a recombinant monoclonal antibody that binds tumor necrosis factor alpha (TNF) thus inhibiting engagement…
Abstract Number: 1522 • 2014 ACR/ARHP Annual Meeting
Impact of Sarilumab on Health Related Quality of Life (HRQoL), Fatigue, and Sleep in Rheumatoid Arthritis Patients at Week 24 – Results of a Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study
Vibeke Strand¹, George Joseph², Hubert van Hoogstraten², Chieh-I Chen³, Chungpeng Fan², Paulo Carita⁴, Neil Graham³, Tanya Momtahen² and Mark C Genovese⁵, ¹Biopharmaceutical Consultant, Portola Valley, CA, ²Sanofi, Bridgewater, NJ, ³Regeneron Pharmaceuticals, Inc., Tarrytown, NY, ⁴Sanofi, Chilly-Mazarin, France, ⁵Division of Immunology and Rheumatology, Stanford University Medical Center, Palo Alto, CA
Background/Purpose: Sarilumab, a fully human monoclonal antibody directed against the IL-6 receptor, demonstrated efficacy in the phase 3 part of the RA-MOBILITY study (NCT01061736) in…
Abstract Number: 1521 • 2014 ACR/ARHP Annual Meeting
Sustained Improvements in Magnetic Resonance Imaging Outcomes with Abatacept Following the Withdrawal of All Treatment in Patients with Early Rheumatoid Arthritis
C Peterfy¹, Gerd Burmester², Vivian P. Bykerk³, B G Combe⁴, J C DiCarlo¹, Daniel E. Furst⁵, T W J Huizinga⁶, C S Karyekar⁷, D Wong⁷, Philip G. Conaghan⁸ and P Emery⁹, ¹Spire Sciences, Inc., Boca Raton, FL, ²Charité – University Medicine Berlin, Berlin, Germany, ³Hospital for Special Surgery, Weill Cornell Medical College, New York, NY, ⁴Hôpital Lapeyronie, Montpellier, France, ⁵University of California at Los Angeles, Los Angeles, CA, ⁶Leiden University Medical Center, Leiden, Netherlands, ⁷Bristol-Myers Squibb, Princeton, NJ, ⁸NIHR-Leeds Musculoskeletal Biomedical Research Unit and Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, United Kingdom, ⁹University of Leeds, Leeds, United Kingdom
Background/Purpose: Biologic treatment can lead to improved clinical outcomes in early RA. In the Assessing Very Early Rheumatoid arthritis Treatment (AVERT) study, abatacept (ABA) +…
Abstract Number: 1520 • 2014 ACR/ARHP Annual Meeting
Gene Expression Analyses of Abatacept- and Adalimumab-Treated Patients from the Ample Trial
S Bandyopadhyay¹, M Maldonado¹, M Schiff², ME Weinblatt³, Roy Fleischmann⁴ and SE Connolly¹, ¹Bristol-Myers Squibb, Princeton, NJ, ²University of Colorado, Denver, CO, ³Brigham and Women's Hospital, Boston, MA, ⁴University of Texas Southwestern Medical Center, Dallas, TX
Background/Purpose: The distinct mechanisms of action (MoA) of abatacept (ABA) and adalimumab (ADA) are expected to manifest in different transcriptional profiles in RA patients (pts).…
Abstract Number: 1519 • 2014 ACR/ARHP Annual Meeting
Implementation of an Acid Dissociation Procedure for Immunogenicity Detection in Patients Treated with ANTI-TNF Drugs
Francisca Llinares-Tello¹, Jose Rosas², José M. Senabre-Gallego³, Gregorio Santos-Soler³, Carlos Santos-Ramirez⁴, Esteban Salas-Heredia³, Xavier Barber⁵, Juan Molina¹, Catalina Cano³, Ana Pons³ and Group Aire-MB³, ¹Laboratory, Hospital Marina Baixa, Villajoyosa, Spain, ²Rheumatology, Hospital Marina Baixa. Villajoyosa, Villajoyosa, Spain, ³Rheumatology, Hospital Marina Baixa, Villajoyosa, Spain, ⁴Rheumatology, Hospital Marina Salud, Denia, Spain, ⁵Universidad Miguel Hernández, CIO, Elche, Spain
Background/Purpose To evaluate the application of an acid dissociation procedure in monitoring patients with subtherapeutic serum concentrations of infliximab (IFX), adalimumab (ADL) and etanercept (ETN),…
Abstract Number: 1518 • 2014 ACR/ARHP Annual Meeting
Disentangling the Effects of Tocilizumab on Neutrophil Survival and Function
Timo Gaber^1,2,3, Martin Hahne⁴, Cindy Strehl², Paula Hoff¹, Yvonne Doerffel⁵, Eugen Feist¹, Gerd Burmester¹ and Frank Buttgereit⁶, ¹Department of Rheumatology and Clinical Immunology, Charité University Medicine, Berlin, Germany, ²German Rheumatism Research Center (DRFZ), Berlin, Germany, ³Berlin-Brandenburg Center of Regenerative Therapies (BCRT), Berlin, Germany, ⁴Berlin-Brandenburg School of Regenerative Therapies (BSRT), Berlin, Germany, ⁵Department of Gastroenterology and Hepatology, Charité University Medicine, Berlin, Germany, ⁶Charité University Hospital, Berlin, Germany
Background/Purpose The synovial tissue in rheumatoid arthritis (RA) represents a hypoxic environment with up-regulated pro-inflammatory cytokines and cellular infiltrates including neutrophils. Tocilizumab, a humanized IgG1…
Abstract Number: 1517 • 2014 ACR/ARHP Annual Meeting
Analysis of Gene Expression Fluctuation with Abatacept Highlights the Involvement of the Proteasome Pathway As a Mechanism of Action of Abatacept in Rheumatoid Arthritis
C Derambure¹, O Vittecoq^1,2, G Dzangue Tchoupou¹, Maria-Antonietta d'Agostino³, P Gaudin⁴, C Gaillez⁵, M Le Bars⁶ and T Lequerré^1,2, ¹Inserm 905, Institute for Biomedical Research, University of Rouen, Rouen, France, ²Department of Rheumatology, Rouen University Hospital, Rouen, France, ³AP-HP Ambroise Paré Hospital, Boulogne-Billancourt, France, ⁴Department of Rheumatology, University Hospital Grenoble, Grenoble, France, ⁵Formerly of Bristol-Myers Squibb, Rueil-Malmaison, France, ⁶Bristol-Myers Squibb, Rueil-Malmaison, France
Background/Purpose: Abatacept (ABA) is a biologic therapy targeting T cells, which play a major role in the pathophysiology of RA. Overall, 57.1% of patients reached…
Abstract Number: 1488 • 2014 ACR/ARHP Annual Meeting
Clinical Efficacy of Add-on Iguratimod Therapy in Patients with Active Rheumatoid Arthritis Despite of Methotrexate ~a Multicenter Registry Study~
Yasuhide Kanayama¹, Toshihisa Kojima², Atsushi Kaneko³, Yuji Hirano⁴, Nobunori Takahashi², Shinya Hirabara⁴ and Naoki Ishiguro², ¹Orthopedic Surgery and Rheumatology, Toyota Kosei Hospital, Toyota, Japan, ²Orthopaedic Surgery and Rheumatology, Nagoya University Graduate School of Medicine, Nagoya, Japan, ³Orthopedic Surgery and Rheumatology, Nagoya Medical Center, Nagoya, Japan, ⁴Rheumatology, Toyohashi Municipal Hospital, Toyohashi, Japan
Background/Purpose Iguratimod (IGU) is a small-molecule antirheumatic drug that was approved in Japan in September 2012. IGU suppressed tumor necrosis factor-alpha-induced production of interleukin (IL)-6,…
Abstract Number: 1486 • 2014 ACR/ARHP Annual Meeting
Rapid Onset of Clinical Benefit Is Associated with a Reduction in Validated Biomarkers of Disease in Patients with Rheumatoid Arthritis Treated with Mavrilimumab, a Human Monoclonal Antibody Targeting GM-CSFRÃ¡
Iain B. McInnes¹, Gerd Burmester², Joel M. Kremer³, Pedro Miranda⁴, Mariusz Korkosz⁵, Jiri Vencovsky⁶, Andrea Rubbert-Roth⁷, Eduardo Mysler⁸, David Close⁹, Matthew A. Sleeman¹⁰, Alex Godwood¹¹, Sara Sandbach¹², Patricia C. Ryan¹³, Dominic Sinibaldi¹⁴, Wendy White¹³, Nadine A. Defranoux¹⁵ and Michael Weinblatt¹⁶, ¹Institute of Infection, Immunity and Inflammation, University of Glasgow, Glasgow, United Kingdom, ²Department of Rheumatology and Clinical Immunology, Charité - University Medicine Berlin, Berlin, Germany, ³Medicine, Albany Medical College and the Center for Rheumatology, Albany, NY, ⁴Centro de Estudios Reumatologicos, Santiago, Chile, ⁵Inernal Medicine and Gerontology, Malopolskie Centrum Medyczne, Krakow, Poland, ⁶Rheumatology, Charles University Institute of Rheumatology, Prague, Czech Republic, ⁷Med Clinic I, University of Cologne, koln, Germany, ⁸Rheumatology, OMI, Buenos Aires, Argentina, ⁹Clinical Development, MedImmune Ltd, Cambridge, United Kingdom, ¹⁰Respiratory, Inflammation and Autoimmunity, MedImmune Ltd, Cambridge, United Kingdom, ¹¹Clinical Biostatics and Data Management, MedImmune Ltd, Cambridge, United Kingdom, ¹²Clinical biologics, MedImmune Ltd, Cambridge, United Kingdom, ¹³Translational Sciences, MedImmune, Gaithersburg, MD, ¹⁴R&D IS Translational & Clinical Informatics, MedImmune, Gaithersburg, MD, ¹⁵Crescendo Bioscience Inc., South San Francisco, CA, ¹⁶Rheumatology, Brigham & Women's Hospital, Harvard Medical School, Boston, MA
Background/Purpose Macrophages are pivotal to rheumatoid pathogenesis and their inflammatory products drive many of the signs and symptoms of disease. Mavrilimumab inhibits macrophage activation and…

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