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  • Abstract Number: 593 • 2016 ACR/ARHP Annual Meeting

    Adalimumab (HUMIRA) Halts Radiographic Progression and Reduces Disease Activity in Patients with a Poor Initial Response to Methotrexate

    Josef S. Smolen1, Ronald F. van Vollenhoven2, Benjamin A. Wolfe3, Su Chen3, Jessica L. Suboticki3 and Arthur Kavanaugh4, 1Division of Rheumatology, Department of Medicine, Medical University of Vienna, and Hietzing Hospital, Vienna, Austria, 2Amsterdam Rheumatology and Immunology Center (ARC), Amsterdam, Netherlands, 3AbbVie Inc., North Chicago, IL, 4Division of Rheumatology, Allergy, and Immunology, University of California – San Diego, La Jolla, CA

    Background/Purpose:  In patients (pts) with early rheumatoid arthritis (RA), conventional synthetic DMARDs (csDMARDs), preferably methotrexate (MTX), are recommended as first line therapy.1,2 For pts who…
  • Abstract Number: 594 • 2016 ACR/ARHP Annual Meeting

    Maintenance of Improvements in Patients’ Physical Function, Workplace and Household Productivity, and Reduction in Caregiver Burden with 2 Years of Certolizumab Pegol Treatment in DMARD-Naive, Early RA Patients with Severe Progressive Disease

    Clifton Bingham III1, Paul Emery2, Michael Weinblatt3, Gerd-Rüdiger Burmester4, Daniel E. Furst5, Xavier Mariette6, Ronald van Vollenhoven7, Brenda VanLunen8, Oana Purcaru9 and Vivian P. Bykerk10, 1Johns Hopkins University, Baltimore, MD, 2University of Leeds, Leeds, United Kingdom, 3Brigham and Women’s Hospital, Boston, MA, 4Charité – University Medicine Berlin, Berlin, Germany, 5David Geffen School of Medicine at UCLA, Los Angeles, CA, 6Université Paris-Sud, Paris, France, 7Amsterdam Rheumatology and Immunology Center (ARC), Amsterdam, Netherlands, 8UCB Pharma, Raleigh, NC, 9UCB Pharma, Slough, United Kingdom, 10Divison of Rheumatology, Hospital for Special Surgery, New York, NY

    Background/Purpose: Rheumatoid arthritis (RA) is associated with loss of physical function, work disability, and decreased quality of life. Early treatment with certolizumab pegol (CZP) in…
  • Abstract Number: 595 • 2016 ACR/ARHP Annual Meeting

    Cinical Responses and Improvements in Patient-Reported Outcomes Are Associated with Increased Productivity in the Workplace and at Home in Rheumatoid Arthritis Patients Treated with Certolizumab Pegol

    Vivian P. Bykerk1, Paul Emery2, Michael Weinblatt3, Gerd-Rüdiger Burmester4, Daniel E. Furst5, Xavier Mariette6, Ronald van Vollenhoven7, Oana Purcaru8, Pauline Ralston9 and Clifton Bingham III10, 1Divison of Rheumatology, Hospital for Special Surgery, New York, NY, 2University of Leeds, Midlothian, United Kingdom, 3Brigham and Women’s Hospital, Boston, MA, 4Charité – University Medicine Berlin, Berlin, Germany, 5David Geffen School of Medicine at UCLA, Los Angeles, CA, 6Université Paris-Sud, Paris, France, 7Amsterdam Rheumatology and Immunology Center (ARC), Amsterdam, Netherlands, 8UCB Pharma, Slough, United Kingdom, 9Hays Pharma, London, United Kingdom, 10Johns Hopkins University, Baltimore, MD

    Background/Purpose: Rheumatoid arthritis (RA) is associated with work disability, loss of productivity and reduced quality of life. In established and early RA, compared with MTX…
  • Abstract Number: 596 • 2016 ACR/ARHP Annual Meeting

    Association Between Plasma Certolizumab Pegol Concentration and Improvement in Disease Activity in Rheumatoid Arthritis and Crohn’s Disease

    Gerrit Wolbink1,2, Philippe Goupille3, William Sandborn4, Hubert Marotte5, Denis Mulleman3, David Ternant3, Stéphane Paul5, Marc de Longueville6, Niels Vande Casteele4,7, Miren Zamacona6, Cathy O'Brien6, Tore K. Kvien8 and Arthur F. Kavanaugh9, 1Amsterdam Rheumatology Immunology Center (ARC), Reade, Amsterdam, Netherlands, 2Department of Immunopathology, Sanquin, Amsterdam, Netherlands, 3Université François-Rabelais, Tours, France, 4Division of Gastroenterology, UC San Diego School of Medicine, La Jolla, CA, 5Centre Hospitalier Universitaire de Saint-Étienne, Saint-Étienne, France, 6UCB Pharma, Brussels, Belgium, 7KU Leuven Department of Pharmaceutical and Pharmacological Sciences, Leuven, Belgium, 8Department of Rheumatology, Diakonhjemmet Hospital, Oslo, Norway, 9Division of Rheumatology, Allergy & Immunology, UC San Diego School of Medicine, La Jolla, CA

    Background/Purpose: Anti-TNFs neutralize the TNF-mediated component of inflammatory diseases such as rheumatoid arthritis (RA) and Crohn’s disease (CD) to reduce disease activity. In this study,…
  • Abstract Number: 597 • 2016 ACR/ARHP Annual Meeting

    Comparative Effectiveness of Different Anti-TNF Drugs As First Biological DMARD in RA: Results from the Nationwide Swedish Register 2010-2015

    Thomas Frisell1, Mats Dehlin2, Daniela Di Giuseppe3, Nils Feltelius4, Alf Kastbom5, Carl Turesson6, Johan Askling7 and the ARTIS Study Group, 1Clinical Epidemiology Unit, Department of Medicine, Karolinska Institutet, Stockholm, Sweden, 2Department of Rheumatology and Inflammation Research, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden, 3Clinical Epidemiology Unit, Dept. of Medicine, K2, Karolinska institutet, Stockholm, Sweden, 4Swedish Medical Products Agency, Uppsala, Sweden, 5Department of Clinical and Experimental Medicine, Rheumatology/AIR, Linköping, Sweden, 6Department of Rheumatology, Skåne University Hospital, Malmö, Sweden, 7Clinical Epidemiology Unit, Department of Medicine, Karolinska Institutet, Stockholm, Sweden, Stockholm, Sweden

    Background/Purpose:  Although evidence from randomized trials suggest similar efficacy and safety on a group level for the different anti-TNF drugs available for the treatment of…
  • Abstract Number: 598 • 2016 ACR/ARHP Annual Meeting

    An Assessment of the Correlation Between Gender and Anticipated Drug Retention to TNF Inhibitors: A Meta-Regression Analysis

    Cathy Lee Ching1, Elie Donath2 and Suresh Kumar3, 1Internal Medicine, University of Miami Miller School of Medicine/ JFK Med Ctr, Palm Beach Regional Campus GME Consortium, Atlantis, FL, 2Internal Medicine, University of Miami Miller School of Medicine, JFK Med Ctr, Palm Beach Regional Campus GME Consortium, Atlantis, FL, 3Rheumatology, Veterans Affairs Medical Center of West Palm Beach, West Palm Beach, FL

    Background/Purpose:  It is generally believed that a wide variety of patient-specific factors, and in particular gender, are likely to influence the response and tolerability of…
  • Abstract Number: 599 • 2016 ACR/ARHP Annual Meeting

    Real World United States-Based Clinical Experience with Prior Biologic Use Among First Time Golimumab Intravenous and Infliximab Treated Rheumatoid Arthritis Patients

    Sergio Schwartzman1, Dennis Parenti2, Shawn Black2, Kehzen Tang3, Yanli Wang3 and Shelly Kafka2, 1Rheumatology, Hospital for Special Surgery, New York, NY, 2Janssen Scientific Affairs, LLC, Horsham, PA, 3Janssen Research & Development, LLC, Spring House, PA

    Background/Purpose:  AWARE (Comparative and Pragmatic Study of Golimumab IV Versus Infliximab in Rheumatoid Arthritis) is a Phase 4 comparator study designed to provide a real-world…
  • Abstract Number: 600 • 2016 ACR/ARHP Annual Meeting

    Disease Activity Trends after Dose Escalation of Infliximab (Remicade) – Results from United States Consortium of Rheumatology Researchers of North America Registry

    Dennis Parenti1, George W. Reed2, Ying Shan2, Kimberly Dandreo2, Joel M. Kremer3 and Raphael J. DeHoratius4, 1Janssen Scientific Affairs, LLC, Horsham, PA, 2Corrona, LLC, Southborough, MA, 3Albany Medical College, Albany, NY, 4Janssen Scientific Affairs, LLC/Sidney Kimmel School of Medicine, Thomas Jefferson University, Horsham/Philadelphia, PA

    Background/Purpose: Dose escalation is a common strategy for patients (pts) on infliximab (IFX).  This study examined the trend in disease activity across dose escalations to…
  • Abstract Number: 601 • 2016 ACR/ARHP Annual Meeting

    Differing Contribution of Methotrexate Polyglutamation to Infliximab and Adalimumab Exposure As Compared to Etanercept

    Thierry Dervieux1, Joel M. Kremer2, Tyler O'Malley1, Alan J Kivitz3, John Conklin4 and Michael Weinblatt5, 1Research and Development, Exagen Diagnostics, Vista, CA, 2Albany Medical College, Albany, NY, 3Altoona Arthritis & Osteo Ctr, Duncansville, PA, 41261 Liberty Way Suite C, Exagen Diagnostics, Vista, CA, 5Division of Rheumatology, Immunology and Allergy, Harvard Medical School, Brigham and Women’s Hospital, Boston, MA

    Background/Purpose: Methotrexate (MTX) is known to improve exposure and clinical outcome to anti-tumor necrosis factor (TNF) therapy. While the precise mechanism of action for the…
  • Abstract Number: 602 • 2016 ACR/ARHP Annual Meeting

    Efficacy and Safety of Switching Between Certolizumab Pegol and Adalimumab after Primary Anti-TNF Treatment Failure: 2-Year Results from a Randomized, Investigator-Blind, Superiority Head-to-Head Study

    Roy Fleischmann1, Gerd-Rüdiger Burmester2, Bernard Combe3, Jeffrey R. Curtis4, Stephen Hall5, Boulos Haraoui6, Ronald van Vollenhoven7, Christopher Cioffi8, Cécile Ecoffet9, Lucian Ionescu10, Leon Gervitz11, Luke Peterson8 and Josef Smolen12, 1University of Texas Southwestern Medical Center at Dallas Metroplex Clinical Research Center, Dallas, TX, 2Charité – University Medicine Berlin, Berlin, Germany, 3Montpellier University Hospital, Montpellier, France, 4The University of Alabama at Birmingham, Birmingham, AL, 5Cabrini Medical Centre, Monash University, Melbourne, Australia, 6Department of Medicine, Centre Hospitalier de l’Université de Montréal, Montreal, QC, Canada, 7Amsterdam Rheumatology and Immunology Center (ARC), Amsterdam, Netherlands, 8UCB Pharma, Raleigh, NC, 9UCB Pharma, Brussels, Belgium, 10Allée De La Recherche 60, UCB Pharma, Brussels, Belgium, 11RA Patient Value Mission, UCB Pharma, Brussels, Belgium, 12Medical University of Vienna and Hietzing Hospital, Vienna, Austria

    Background/Purpose: EULAR, ACR and treat-to-target guidelines recommend switching treatment in inadequate responders (IRs) to alternative therapy by Week (Wk) 12.1-3 Although any biological (b)DMARD can…
  • Abstract Number: 603 • 2016 ACR/ARHP Annual Meeting

    Additional Efficacy Results of SB4 (Etanercept Biosimilar) up to Week 100: Comparison Between Continuing SB4 and Switching from Reference Etanercept (Enbrel®) to SB4

    Paul Emery1, Jiří Vencovský2, Anna Sylwestrzak3, Piotr Leszczyñski4, Wieslawa Porawska5, Barbara Stasiuk6, Joanna Hilt7, Zdenka Mosterova8, Soo Yeon Cheong9 and Jeehoon Ghil9, 1University of Leeds, Midlothian, United Kingdom, 2Institute of Rheumatology, Department of Rheumatology, 1st Faculty of Medicine, Charles University, Prague, Czech Republic, 3NZOZ Medica Pro Familia Sp. z o.o., Warsaw, Poland, 4Rheumatology and Rehabilitation, Poznan University of Medical Sciences, Poznan, Poland, 5Poznanski Osrodek Medyczny NOVAMED, Poznan, Poland, 6Medicome Sp. z o.o., Oswiecim, Poland, 7Centrum Terapii Wspolczesnej J.M. Jasnorzewska sp., Bialystok, Poland, 8Revmacentrum MUDr.Mostera sro, Brno, Czech Republic, 9Samsung Bioepis Co., Ltd., Incheon, South Korea

    Background/Purpose: SB4 is approved by the European Medicines Agency as a biosimilar of the reference etanercept (ETN). Long term safety and efficacy of SB4 up…
  • Abstract Number: 604 • 2016 ACR/ARHP Annual Meeting

    Sustained Efficacy and Comparable Safety and Immunogenicity after Transition to SB5 (an Adalimumab Biosimilar) Vs. Continuation of SB5 or Reference Adalimumab (Humira®) in Patients with Rheumatoid Arthritis: Results of Phase III Study

    Michael Weinblatt1, Asta Baranauskaite2, Jaroslaw Niebrzydowski3, Eva Dokoupilova4, Agnieszka Zielinska5, Karina Sitek-Ziolkowska6, Janusz Jaworski7, Artur Racewicz8, Margarita Pileckyte2, Krystyna Jedrychowicz-Rosiak9, Vyacheslav Zhdan10, Soo Yeon Cheong11 and Jeehoon Ghil11, 1Brigham and Women’s Hospital, Boston, MA, 2Lithuanian University of Health Sciences, Kaunas, Lithuania, 3Medica Pro Familia, Gdynia, Poland, 4MEDICAL PLUS s.r.o, Uherske Hradiste, Czech Republic, 5Medica Pro Familia Sp. z o.o. Spolka Komandytowo-Akcyjna, Warszawa, Poland, 6Medica pro Familia, Katowice, Poland, 7Reumatika Centrum Reumatologi, Warszawa, Poland, 8Zdrowie Osteo- Medic s.c, Bialystok, Poland, 9Przychodnia Neuromedyka, Zyrardów, Poland, 10M.V.Sklifosovskyi Poltava Regional Clinical Hospital, Poltava, Ukraine, 11Samsung Bioepis Co., Ltd., Incheon, South Korea

    Background/Purpose: SB5 has been developed as a biosimilar of the reference adalimumab (ADL). The 24-week results of the phase III study have been reported.1 Efficacy,…
  • Abstract Number: 605 • 2016 ACR/ARHP Annual Meeting

    Assessment of Comparative Immunogenicity in Biosimilar Development: Immunogenicity and Pharmacokinetics Following a Single Dose of M923, a Proposed Biosimilar for Reference Adalimumab (HUMIRA®), Compared with US- and EU-Sourced Reference Adalimumab in Healthy Subjects

    Jan Hillson1, Tim Mant2, Tanmoy Ganguly3, William Avery3, Molly Rosano3, Carolyn Huntenburg3, Donna Palmer4, Siddesh Darne4, Borislava Pavlova4, Jennifer Doralt4, Russell Reeve5, Niti Goel5, Doris Weilert5, Paul Rhyne6, John Caminis4 and James Roach3, 1Clinical Research, Momenta Pharmaceuticals, Inc., Cambridge, MA, 2Quintiles Drug Research Unit at Guy's Hospital, London, London, United Kingdom, 3Momenta Pharmaceuticals, Inc., Cambridge, MA, 4Shire, Cambridge, MA, 5Quintiles, Inc., Durham, NC, 6Q2 Solutions, Marietta, GA

    Background/Purpose:  324 healthy volunteers were randomized 1:1:1 to receive a single 40 mg dose of M923, US-sourced reference adalimumab, or EU-sourced reference adalimumab by subcutaneous…
  • Abstract Number: 606 • 2016 ACR/ARHP Annual Meeting

    A Randomized, Double Blind, Single Dose Study to Assess the Pharmacokinetics, Safety, and Tolerability of ONS-3010 (Adalimumab, Oncobiologics, Inc.) Compared to Two Reference Products of Humira® (AbbVie) in Healthy Adult Subjects

    Kenneth Bahrt1, Joannes Reijers2, Marlous Dillingh2, Claudia Rehrig1 and Jacobus Burggraaf3, 1Oncobiologics Inc, Cranbury, NJ, 2Centre for Human Drug Research, Leiden, Netherlands, 3Centre for Human Drug Research, Leiden,, Netherlands

    ONS-3010 is being developed as a biosimilar candidate of Humira® (Adalimumab), a full-length recombinant human IgG1 monoclonal antibody specific for TNFα. This study evaluated the b,…
  • Abstract Number: 607 • 2016 ACR/ARHP Annual Meeting

    The Clinical Response to Biologic and Non-Biologic Disease Modifying Antirheumatic Drugs (DMARDs) According to Gender in a French-Canadian Population with Rheumatoid Arthritis (RA)

    Sonia Lagacé1, Louis Bessette2,3, Louis Coupal4 and Denis Choquette4, 1Medicine, Laval University, Quebec, QC, Canada, 2Rheumatology, Laval University, Québec, QC, Canada, 3Rhumatologie, CHU de Québec - Université Laval, Quebec, QC, Canada, 4Rheumatology, Institut de Recherche en Rhumatologie de Montréal (IRRM), Montréal, QC, Canada

    Background/Purpose: Several studies have reported that women with RA had higher level of pain, disease activity and functional impairment compared to men. In addition, women…
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