ACR Meeting Abstracts

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  • Abstract Number: 1613 • 2016 ACR/ARHP Annual Meeting

    Safe and Effective Tocilizumab Therapy in Elderly Patients with Rheumatoid Arthritis

    Christof Specker1, Jörg Kaufmann2, Herbert Kellner3, Peter Kaestner4, Christoph Volberg5, Verena Braunewell6, Martin Aringer7, Maren Sieburg8, Lothar Meier9, Michael Hofmann10, Jan-Paul Flacke11, Hans-Peter Tony12 and Gerhard Fliedner13, 1Rheumatology & Clinical Immunology, University Hospital Essen, Essen, Germany, 2Ambulant Centres for Rheumatology, Ludwigsfelde, Germany, 3Specialist Practice for Rheumatology and Gastroenterology, Munich, Germany, 4Outpatient department of Rheumatology, MVZ Ambulantes Rheumazentrum, Erfurt, Germany, 5Rheumazentrum Neuss, Neuss, Germany, 6Schwerpunktpraxis Rheumatologie, Moenchengladbach, Germany, 7Rheumatology, Medicine III, University Clinical Center Technical University of Dresden, Dresden, Germany, 8Rheumatologische Gemeinschaftspraxis, Magdeburg, Germany, 9Gemeinschaftspraxis für Innere Medizin - Rheumatologie, Hofheim am Taunus, Germany, 10Rheumatology, Chugai Pharma Europe Ltd., Frankfurt, Germany, 11Rheumatology, Roche Pharma AG, Grenzach-Wyhlen, Germany, 12Rheumatology/Immunology, Medical Clinic II, University Clinic Wuerzburg, Würzburg, Germany, 13Internal Med/Rheumatology, Rheumatological Practice, Osnabrueck, Germany

    Background/Purpose: The non-interventional study ICHIBAN was set up in 2010 to evaluate the effectiveness and safety of intravenously administered Tocilizumab (TCZ IV) in patients (pts)…
  • Abstract Number: 1614 • 2016 ACR/ARHP Annual Meeting

    Monotherapy with Abatacept, Rituximab or Tocilizumab Is Not Associated with a Significantly Lower Long Term Retention Than Combination with Synthetic DMARD: Long-Term Registry Data in 4498 Real-Life Patients with Rheumatoid Arthritis

    Jacques-Eric Gottenberg1, Jacques Morel2, Arnaud Constantin3, Thomas Bardin4, Alain G. Cantagrel5, Bernard Combe6, Maxime Dougados7, Rene-Marc Flipo8, Alain Saraux9, Thierry Schaeverbeke10, Jean Sibilia11, Martin Soubrier12, Olivier Vittecoq13, Elodie Perrodeau14, Philippe Ravaud15, Xavier Mariette16 and on behalf of the French Society of Rheumatology and of all the investigators participating to the AIR, ORA and REGATE registries, 1Department of Rheumatology, Strasbourg University Hospital, Strasbourg, France, 2Rheumatology, Department of Rheumatology, Montpellier University Hospital, Montpellier, France, 3Rheumatology, CHU Purpan - Hopital Pierre-Paul Riquet, Toulouse, France, 4Clinique de Rhumatologie, Hopital Lariboisiere, Paris Cedex 10, France, 5Rheumatology, Centre Hospitalier Universitaire, Toulouse Purpan, Toulouse, France, 6Département Rhumatologie, Hôpital Lapeyronie, Montpellier, France, 7Rheumatology, Paris Descartes University, Paris, France, 8Rheumatology, University Hospital, Lille, France, 9Rheumatology, Brest University Hospital, Brest, France, 10Rheumatology, CHU Bordeaux, Bordeaux, France, 11Department of Rheumatology, Strasbourg University Hospital, Strasbourg, France, 12Rheumatology, Department of Rheumatology, CHU Gabriel Montpied, Clermont-Ferrand, France, 13Rheumatology, Rouen University Hospital &INSERM U905, Rouen, France, 14Epidemiology, Hopital Hotel Dieu, Paris Descartes University, Paris, France, 15Epidemiologist, PARIS, France, 16Rheumatology, Rheumatology department, Bicetre Hospital, Paris-Sud University, Le Kremlin Bicetre, France

    Background/Purpose: Data are very limited concerning the association between cotreatment with a conventional synthetic DMARD (csDMARD) and long term retention of abatacept (ABA), rituximab (RTX) and tocilizumab…
  • Abstract Number: 1615 • 2016 ACR/ARHP Annual Meeting

    Sirukumab, an Anti–IL-6 Cytokine Monoclonal Antibody, Significantly Improves Physical Function and Reduces Morning Stiffness in Patients with Active Rheumatoid Arthritis Despite Anti-TNF Therapy: Results from a Global, Randomized, Placebo-Controlled, Phase 3 Trial

    Yoshiya Tanaka1, Clifton Bingham III2, Daniel Aletaha3, Prasheen Agarwal4, Sharon Popik4, Regina Kurrasch5, Steve Peterson4, Rita Ganguly5, Chenglong Han4 and Kelly McQuarrie4, 1University of Occupational and Environmental Health, Kitakyushu, Japan, 2Division of Rheumatology, Johns Hopkins University School of Medicine, Baltimore, MD, 3Division of Rheumatology, Medical University of Vienna, Vienna, Austria, 4Janssen Research & Development, LLC, Spring House, PA, 5GlaxoSmithKline, Collegeville, PA

    Background/Purpose: Improvement in physical function and morning stiffness are key goals of rheumatoid arthritis (RA) treatment.  Sirukumab, a selective human anti–IL6 monoclonal antibody, has recently…
  • Abstract Number: 1616 • 2016 ACR/ARHP Annual Meeting

    Mavrilimumab, a Fully Human Granulocyte-Macrophage Colony-Stimulating Factor Receptor-α Monoclonal Antibody: Long-Term Safety and Efficacy for up to 158 Weeks of Treatment in Patients with Rheumatoid Arthritis

    GR Burmester1, IB McInnes2, JM Kremer3, P Miranda4, J Vencovský5, A Godwood6, M Albulescu6, D Close^6 and Michael Weinblatt7, 1Charité – University Medicine Berlin, Berlin, Germany, 2University of Glasgow, Glasgow, United Kingdom, 3The Albany Medical College, Albany, NY, 4Centro De Estudios Reumatológicos, Santiago, Chile, 5Charles University, Prague, Czech Republic, 6MedImmune, Cambridge, United Kingdom, 7Brigham and Women’s Hospital, Boston, MA

    Background/Purpose: Inhibition of GM–CSFR-α is a novel approach to treat RA. Mavrilimumab, an investigational human monoclonal antibody targeting GM–CSFR-α, has demonstrated efficacy and an acceptable…
  • Abstract Number: 1617 • 2016 ACR/ARHP Annual Meeting

    Treatment with Sirukumab, an Anti-IL6 Cytokine Monoclonal Antibody, Improves Fatigue and Health-Related Physical and Emotional Well Being in Patients with Active Rheumatoid Arthritis Refractory to Conventional or Biologic Therapy: Results of 2 Global, Placebo-Controlled, Phase 3 Trials

    Clifton Bingham III1, Yoshiya Tanaka2, George Karpouzas3, Tsutomu Takeuchi4, Daniel Aletaha5, Carter Thorne6, Shihong Sheng7, Weichun Xu7, Ravi Rao8, Kaiyin Fei7, Benjamin Hsu7, Prasheen Agarwal7, Sharon Popik7, Regina Kurrasch9, Steve Peterson7, Rita Ganguly9, Chenglong Han7 and Kelly McQuarrie7, 1Division of Rheumatology, Johns Hopkins University School of Medicine, Baltimore, MD, 2University of Occupational and Environmental Health, Kitakyushu, Japan, 3Division of Rheumatology, Harbor-UCLA Medical Center, Torrance, CA, 4Division of Rheumatology, Keio University School of Medicine, Tokyo, Japan, 5Division of Rheumatology, Medical University of Vienna, Vienna, Austria, 6University of Toronto and Southlake Regional Health Centre, Newmarket, ON, Canada, 7Janssen Research & Development, LLC, Spring House, PA, 8GSK Medicines Research Centre, Stevenage, Hertfordshire, United Kingdom, 9GlaxoSmithKline, Collegeville, PA

    Background/Purpose: Patients (pts) with rheumatoid arthritis (RA) often experience both substantial fatigue and a decline in their health-related physical and emotional well-being. Sirukumab is a…
  • Abstract Number: 1618 • 2016 ACR/ARHP Annual Meeting

    Leflunomide, Sulfasalazine and Hydroxychloroquine for Rheumatoid Arthritis: Efficacious but Poorly Tolerated

    Kyle A. Register1, Amy C. Cannella2, Ted R. Mikuls3 and James R. O'Dell4, 1Division of Rheumatology and Immunology, University of Nebraska Medical Center, Omaha, NE, 2Section of Rheumatology, University of Nebraska Medical Center, Omaha, NE, 3Internal Medicine, Division of Rheumatology, University of Nebraska Medical Center, Omaha, NE, 4Department of Internal Medicine, University of Nebraska Medical Center, Omaha, NE

    Background/Purpose: The combination of methotrexate (MTX), sulfasalazine (SSZ) and hydroxychloroquine (HCQ) (triple therapy) is a highly effective and well-tolerated treatment in rheumatoid arthritis (RA). While…
  • Abstract Number: 1619 • 2016 ACR/ARHP Annual Meeting

    EARTH EXPLORER 2, a Phase IIb Exploratory Study Evaluating Efficacy and Safety of Mavrilimumab, a Fully Human Granulocyte-Macrophage Colony-Stimulating Factor Receptor-Alpha Monoclonal Antibody, and the Tumor Necrosis Factor Antagonist Golimumab in Rheumatoid Arthritis

    Michael Weinblatt1, IB McInnes2, JM Kremer3, P Miranda4, J Vencovský5, A Godwood6, M Albulescu6, D Close^6 and GR Burmester^7, 1Brigham and Women’s Hospital, Boston, MA, 2University of Glasgow, Glasgow, United Kingdom, 3The Albany Medical College, Albany, NY, 4Centro De Estudios Reumatológicos, Santiago, Chile, 5Charles University, Prague, Czech Republic, 6MedImmune, Cambridge, United Kingdom, 7Charité – University Medicine Berlin, Berlin, Germany

    Background/Purpose: Mavrilimumab, a fully human monoclonal antibody targeting the granulocyte-macrophage colony-stimulating factor receptor-α, has demonstrated efficacy and safety in disease-modifying antirheumatic drug (DMARD)-inadequate responder (IR)…
  • Abstract Number: 1620 • 2016 ACR/ARHP Annual Meeting

    Pharmacokinetics, Pharmacodynamics, and Immunogenicity of MEDI4920, a Novel, Engineered CD40 Ligand Antagonist, in Healthy Volunteers

    Jing Li1, Michele Gunsior2, Neang Ly1, Alex Godwood3, David Howe3, Marius Albulescu3, Lisa H Butler3, Krista Arbaugh2 and Raffaella Faggioni1, 1MedImmune, Mountain View, CA, 2MedImmune, Gaithersburg, MD, 3MedImmune, Cambridge, United Kingdom

    Background/Purpose:  Fifty-six healthy adult male subjects were randomized in the study at a single site and administered either placebo or MEDI4920 (3, 10, 30, 100,…
  • Abstract Number: 1621 • 2016 ACR/ARHP Annual Meeting

    A Phase I, Randomized, Double Blind, Placebo-Controlled, Dose Escalating Study of the Safety, Tolerability and Pharmacokinetics and Pharmacodynamics of Single and Multiple Doses of Hmpl‑523 in Australian Male Healthy Subjects

    Jason Lickliter1, Yan Wu2, Ye Hua2, Irena Yuan2, Guangxiu Dai2, Xiong Li2, Jian Wang2, Yang Sai2, Zhongcui Sun2, Angela Pan2, Jing Li2 and Weiguo Su2, 1Nucleus Network, Melbourne, Australia, 2Hutchison MediPharma Limited, Shanghai, China

    Background/Purpose:   Spleen Tyrosine Kinase (SYK) plays a pivotal role in the regulation of downstream signals in immune receptors, including B cell receptors (BCRs), which…
  • Abstract Number: 1622 • 2016 ACR/ARHP Annual Meeting

    Safety and Efficacy of Iguratimod in Patients with Active Rheumatoid Arthritis: A Multicenter, Single-Arm, Open-Label, Real World Study

    Rong Mu, Department of Rheumatology and Immunology, Peking University People's Hospital, Beijing, China

    Background/Purpose:  To evaluate the safety and efficacy of iguratimod, a novel DMARD, in active rheumatoid arthritis patients. Methods:  Patients with active rheumatoid arthritis received iguratimod…
  • Abstract Number: 1623 • 2016 ACR/ARHP Annual Meeting

    Early Effects of Tofacitinib on Bone Homeostasis in Patients with Rheumatoid Arthritis

    Masayasu Kitano1, Sachie Kitano1, Tetsuya Furukawa2, Yuichi Yokoyama3, Aki Nishioka1, Masahiro Sekiguchi1, Naoto Azuma1, Kiyoshi Matsui1 and Hajime Sano1, 1Division of Rheumatology, Department of Internal Medicine, Hyogo College of Medicine, Nishinomiya, Japan, 2Division ofRheumatology Department of internal medicine, Hyogo College of Medicine, Nishinomiya, Japan, 3Division of Rheumatology, Department of internal medicine, Hyogo College of Medicine, Nishinomiya, Japan

    Background/Purpose: The selective Janus kinase (JAK) inhibitor tofacitinib inhibits progression of structural damage in rheumatoid arthritis (RA). These results suggest the possibility that tofacitinib improves…
  • Abstract Number: 1624 • 2016 ACR/ARHP Annual Meeting

    Safety of Surgery in Patients Treated with Tocilizumab for Rheumatoid Arthritis : Data from a French Registry

    Marie Locci1, Bernard Combe2, Cédric Lukas3, Maxime Dougados4, Rene-Marc Flipo5, Christian Marcelli6, Stephanie Rist Bouillon7, Jean Sibilia8 and Jacques Morel9, 1rheumatology, CHU Lapeyronie, MONTPELLIER, France, 2Département Rhumatologie, Hôpital Lapeyronie, Montpellier, France, 3Rheumatology, CHU Lapeyronie and EA2415, Montpellier University, University of Montpellier, France, 4Rheumatology, Paris Descartes University, Paris, France, 5Rheumatology, University Hospital, Lille, France, 6Rheumatology dept, University Hospital Centre of Caen, Caen, France, 7Rhumatologie, Hopital La Source, La Source, France, 8Department of Rheumatology, Strasbourg University Hospital, Strasbourg, France, 9Rheumatology, Department of Rheumatology, Montpellier University Hospital, Montpellier, France

    Background/Purpose: Rheumatoid Arthritis (RA) patients have a higher risk of post-operative complications compared with the general population, especially considering the risk of infection. It remains…
  • Abstract Number: 1625 • 2016 ACR/ARHP Annual Meeting

    Analysis of a Phase 3 Study Evaluating the Efficacy of Sirukumab, an Anti-IL-6 Cytokine Monoclonal Antibody, Across Subgroups in Patients with Active Rheumatoid Arthritis Despite Treatment with Disease-Modifying Anti-Rheumatic Drugs

    Carter Thorne1, George Karpouzas2, Tsutomu Takeuchi3, Shihong Sheng4, Weichun Xu4, Ravi Rao5, Kaiyin Fei4 and Benjamin Hsu4, 1University of Toronto and Southlake Regional Health Centre, Newmarket, ON, Canada, 2Division of Rheumatology, Harbor-UCLA Medical Center, Torrance, CA, 3Division of Rheumatology, Keio University School of Medicine, Tokyo, Japan, 4Janssen Research & Development, LLC, Spring House, PA, 5GSK Medicines Research Centre, Stevenage, Hertfordshire, United Kingdom

    Background/Purpose: Sirukumab is a human monoclonal antibody that selectively binds to the IL-6 cytokine with high affinity, and is under development for rheumatoid arthritis (RA)…
  • Abstract Number: 1626 • 2016 ACR/ARHP Annual Meeting

    In Real Life Rheumatoid Arthritis Patients, Leflunomide Has Limited Impact As a Second Line DMARD after Methotrexate

    Gundula Weigt, Anne Erler and Martin Aringer, Medicine III, University Medical Center and Faculty of Medicine at the TU Dresden, Dresden, Germany

    Background/Purpose:  In patients with rheumatoid arthritis (RA), in whom methotrexate (MTX) is not inducing remission or at least low disease activity, or is not tolerated,…
  • Abstract Number: 1627 • 2016 ACR/ARHP Annual Meeting

    Network Meta-Analysis to Assess the Relative Efficacy of Sirukumab, an Anti–IL-6 Cytokine Monoclonal Antibody, in Combination Therapy for Patients with Active Rheumatoid Arthritis Despite Conventional Dmards

    Steve Peterson1, Maud Pacou2, Drifa Belhadi2, Suzy Van Sanden1, Thomas Webb1, Rita Ganguly3, Regina Kurrasch3, Ravi Rao3, Benjamin Hsu1, Kaiyin Fei1, Danuta Kielar1 and Rafael Alfonso3, 1Janssen Research & Development, LLC, Spring House, PA, 2Amaris, Paris, France, 3GSK Medicines Research Centre, Stevenage, Hertfordshire, United Kingdom

    Background/Purpose: Sirukumab is a human anti-interleukin-6 cytokine monoclonal antibody evaluated for the treatment of moderate to severe active rheumatoid arthritis (RA) and other diseases.  Our…
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