ACR Meeting Abstracts

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  • Abstract Number: 1280 • 2012 ACR/ARHP Annual Meeting

    Sustained Efficacy Responses and a Consistent Safety Profile with Rituximab Repeat Treatment Over 5 Years in Patients with Rheumatoid Arthritis and an Inadequate Response to Tumour Necrosis Factor Inhibitors

    Edward Keystone1, Stanley B. Cohen2, Paul Emery3, Joel M. Kremer4, Maxime R. Dougados5, James E. Loveless6, Carol Chung7, Pamela Wong7, Patrica B. Lehane8 and Helen Tyrrell8, 1The Rebecca MacDonald Centre for Arthritis and Autoimmunity, Mount Sinai Hospital, Toronto, ON, Canada, 2Metroplex Clinical Research Center, Dallas, TX, 3Division of Rheumatic & Musculoskeletal Disease, University of Leeds, Leeds, United Kingdom, 4Center for Rheumatology, Albany Medical College, Albany, NY, 5Hopital Cochin, René Descartes University, Paris, France, 6St Luke's Rheumatology, Boise, ID, 7Genentech, Inc., South San Francisco, CA, 8Roche Products Limited, Welwyn Garden City, United Kingdom

    Background/Purpose: In the REFLEX study conducted in anti-TNF inadequate responder (TNF-IR) patients with RA, a single course of rituximab (RTX) in combination with methotrexate (MTX)…
  • Abstract Number: 1281 • 2012 ACR/ARHP Annual Meeting

    IL-6 Signaling Inhibition Improves Abnormal Bone Homeostasis in Active Rheumatoid Arthritis

    Masayasu Kitano1, Sachie Kitano1, Chieri Sato1, Kazuyuki Fujita1, Takahiro Yoshikawa1, Yuki Katashima1, Masahiro Sekiguchi1, Naoto Azuma1, Naoaki Hashimoto, Shinichiro Tsunoda1, Kiyoshi Matsui1 and Hajime Sano1, 1Division of Rheumatology, Department of Internal Medicine, Hyogo College of Medicine, Nishinomiya-city, Japan

    Background/Purpose: Tocilizumab (TCZ) is a humanized monoclonal anti-IL-6 receptor antibody. TCZ has demonstrated efficacy in moderate to severe active rheumatoid arthritis (RA) with inadequate clinical…
  • Abstract Number: 1282 • 2012 ACR/ARHP Annual Meeting

    Tofacitinib, an Oral Janus Kinase Inhibitor, in the Treatment of Rheumatoid Arthritis: Open-Label, Long-Term Extension Safety and Efficacy up to 48 Months

    Jurgen Wollenhaupt1, Joel C. Silverfield2, Eun Bong Lee3, Susan P. Wood4, Koshika Soma5, Lisy Wang4, Hiroyuki Nakamura6, Yoshihiro Komuro6, Chudi I. Nduaka4, David Gruben4, Birgitta Benda7, Samuel H. Zwillich5, Richard Riese4 and John D. Bradley4, 1Schoen-Klinik Hamburg-Eilbek Teaching Hospital of the University of Hamburg, Hamburg, Germany, 2Healthpoint Medical Group, Tampa, FL, 3Seoul National University, Seoul, South Korea, 4Pfizer Inc., Groton, CT, 5Pfizer Inc, Groton, CT, 6Pfizer Japan Inc., Tokyo, Japan, 7Pfizer Inc., Collegeville, PA

    Background/Purpose: Tofacitinib is a novel, oral Janus kinase inhibitor being investigated as a targeted immunomodulator and disease-modifying therapy in RA. Here we report the safety…
  • Abstract Number: 1283 • 2012 ACR/ARHP Annual Meeting

    Effects of Tofacitinib On Patient-Reported Outcomes in Patients with Active Rheumatoid Arthritis Receiving Stable-Dose Methotrexate: Results of Two Phase 3 Studies

    Gerd Burmester1, Désirée van der Heijde2, Vibeke Strand3, Cristiano A. F. Zerbini4, Carol A. Connell5, Charles A. Mebus5, Samuel H. Zwillich6, John D. Bradley5, David Gruben5 and Gene Wallenstein5, 1Department of Rheumatology and Clinical Immunology, Charité – University Medicine Berlin, Berlin, Germany, 2Rheumatology, Leiden University Medical Center, Leiden, Netherlands, 3Adjunct, Division of Immunology / Rheumatology, Stanford University, Palo Alto, CA, 4Centro Paulista de Investigação Clinica, Sao Paulo, Brazil, 5Pfizer Inc., Groton, CT, 6Pfizer Inc, Groton, CT

    Background/Purpose: Tofacitinib is a novel, oral Janus kinase inhibitor being investigated as a targeted immunomodulator and disease-modifying therapy for RA. The efficacy and safety of…
  • Abstract Number: 1284 • 2012 ACR/ARHP Annual Meeting

    Evaluation of Influenza and Pneumococcal Vaccine Responses in Patients with Rheumatoid Arthritis Receiving Tofacitinib

    K. L. Winthrop1, A. Racewicz2, E. B. Lee3, B. Wilkinson4, S. H. Zwillich5, K. Soma4, S. Rottinghaus4, T. Kawabata4, R. Riese5, S. Wood5, J. Bradley6 and Clifton O. Bingham III7, 1Division of Infectious Diseases, Oregon Health and Science University, Portland, OR, 2Department of Internal Medicine and Osteoarthrology, Bialystok Regional Hospital, Bialystok, Poland, 3Seoul National University, Seoul, South Korea, 4Pfizer Inc, Groton, CT, 5Pfizer Inc., Groton, CT, 6Worldwide Pharmaceutical Development, Pfizer Inc., Groton, CT, 7Rheumatology, Johns Hopkins University, Baltimore, MD

    Background/Purpose: Tofacitinib is a novel, oral Janus kinase inhibitor being investigated as a targeted immunomodulator and disease-modifying therapy for RA. Clinical guidelines recommend the use…
  • Abstract Number: 1285 • 2012 ACR/ARHP Annual Meeting

    Short-Term Efficacy of Etanercept Plus Methotrexate Vs.Various Disease-Modifying Anti-Rheumatic Combinations with Methotrexate in Established Rheumatoid Arthritis

    Roy Fleischmann1, Andrew S. Koenig2, Annette Szumski3, Henk Nab4, Lisa Marshall5 and Eustratios Bananis3, 1University of Texas Southwestern Medical Center, Dallas, TX, 2Specialty Care Business Unit, Pfizer Inc., Collegeville, PA, 3Specialty Care, Pfizer Inc., Collegeville, PA, 4Pfizer Europe, Rome, Italy, 5Pfizer Inc., Collegeville, PA

    Background/Purpose: The objective of this study was to assess the short-term benefit of etanercept (ETN) + methotrexate (MTX) vs. various disease-modifying anti-rheumatic drugs (DMARDs; hydroxychloroquine…
  • Abstract Number: 1286 • 2012 ACR/ARHP Annual Meeting

    Antibodies to Etanercept and Adalimumab in Rheumatoid Arthritis Inadequate Responders and Clinical Outcomes After an Active Switch to Infliximab

    Chad Pool1, Gopi Shankar2, Allen Schantz2, George Gunn2, Rebecca Bolce3, Marjatta Leirisalo-Repo4, Jim Wang1, John A. Goldman5, Raphael J. DeHoratius6, Roy Fleischmann7 and Dennis Decktor6, 1Janssen Services, LLC, Horsham, PA, 2Janssen R&D, LLC, PA, 3Crescendo Bioscience Inc., South San Francisco, CA, 4Department of Medicine, Division of Rheumatology, Helsinki University Central Hospital, Helsinki, Finland, 5Medical Quarters #293, Atlanta, GA, 6Medical Affairs, Janssen Services, LLC, Horsham, PA, 7Rheumatology, University of Texas Southwestern Medical Center and Metroplex Clinical Research Center, Dallas, TX

    Background/Purpose: To determine if RA patients (pts) who had an inadequate response to etanercept(ETN) or adalimumab(ADA) and developed antibodies (Abs) to ETN or ADA responded…
  • Abstract Number: 1287 • 2012 ACR/ARHP Annual Meeting

    Rheumatoid Arthritis Comparison of Active Therapies in Methotrexate Suboptimal Responders: Validation of the Strategy of Conventional Disease Modifying Anti-Rheumatic Drugs Before Biologicals

    James R. O'Dell1, Ted R. Mikuls2, Thomas Taylor3, Vandana Ahluwalia4, Mary Brophy5, Stuart Warren6, Robert Lew5, Ciaran Phibbs7, Aslam H. Anis8, Amy C. Cannella9, Gary A. Kunkel10, Alan R. Erickson2, Edward Keystone11 and the CSP551 RACAT Research Group12, 1Dept of Internal Medicine, Omaha VA and University of Nebraska Medical Center, Omaha, NE, 2Omaha VA Medical Center and University of Nebraska Medical Center, Omaha, NE, 3VA Medical Center, White River Junction, VT, 4William Osler Health Center, Brampton, ON, Canada, 5VA Boston Heathcare System, Boston, MA, 6VA CSP Clinical Research Pharmacy Coordinating Center, Albuquerque, NM, 7Health Economics Resource Center (152), Palo Alto VA Health Care System, Menlo Park, CA, 8Population and Public Health, Univ of British Columbia, Vancouver, BC, Canada, 9Divison of Rheumatology, Omaha VA and University of Nebraska Medical Center, Omaha, NE, 10Div of Rheumatology, George Wahlen Veterans Affairs Medical Center, Salt Lake City, UT, 11University of Toronto, Toronto, ON, Canada, 12Boston, MA

    Background/Purpose: Double-blind placebo controlled randomized trials have demonstrated the efficacy of 15 different therapies in RA patients with active disease despite methotrexate (MTX). No blinded…
  • Abstract Number: 1288 • 2012 ACR/ARHP Annual Meeting

    A Significant Number of Patients with Chronic Arthritis Received a Reduced Dosage of Biological Drugs: an Observational Study in Clinical Practice

    Jose Inciarte-Mundo1, Maria Victoria Hernández2, Violeta Rosario1, Sonia Cabrera1, Virginia Ruiz-Esquide3, Maria Eugenia Gomez-Caballero1, Jose A. Gómez-Puerta1, Julio Ramirez1, Juan D. Cañete2 and Raimon Sanmarti1, 1Arthritis Unit. Rheumatology Department, Hospital Clínic of Barcelona, Barcelona, Spain, 2Rheumatology, Hospital Clínic of Barcelona. IDIBAPS. University of Barcelona, Barcelona, Spain, 3Rheumatology, Hospital Clinic, Barcelona, Spain

    Background/Purpose: Biological agents are used to treat chronic arthritis according to the standard dosages from phase III clinical trials. However, in some patients, a good…
  • Abstract Number: 1289 • 2012 ACR/ARHP Annual Meeting

    Abatacept Biologic-Free Remission Study in Established Rheumatoid Arthritis Patients. Orion Study

    Tsutomu Takeuchi1, Tsukasa Matsubara2, Shuji Ohta3, Masaya Mukai4, Koichi Amano5, Shigeto Tohma6, Yoshiya Tanaka7, Hisashi Yamanaka8 and Nobuyuki Miyasaka9, 1Keio University School of Medicine, Tokyo, Japan, 2Matsubara Mayflower Hospital, Hyogo, Japan, 3Department of Rheumatology, Taga General Hospital, Ibaraki, Japan, 4Dept Rheumatology & Hematology, Sapporo City General Hospital, Sapporo, Japan, 5Department of Rheumatology and Clinical Immunology, Saitama Medical Center, Saitama Medical University, Saitama, Japan, 6Clinical Research Center for Allergy and Rheumatology, Sagamihara Hospital, National Hospital Organization, Sagamihara, Japan, 7The First Department of Internal Medicine, University of Occupational and Environmental Health, Kitakyushu, Japan, 8Institute of Rheumatology, Tokyo Women's Medical University, Tokyo, Japan, 9Department of Medicine and Rheumatology and Global Center of Excellence Program, Tokyo Medical and Dental University, Tokyo, Japan

    Background/Purpose: Abatacept (ABA) has comparable efficacy to TNF inhibitors in achieving clinical remission in rheumatoid arthritis (RA) patients. However, although clinical evidence suggests that biologic-free…
  • Abstract Number: 1290 • 2012 ACR/ARHP Annual Meeting

    Effects of Tofacitinib On Lipid Profiles and Cholesterol and Lipoprotein Kinetics in Patients with Rheumatoid Arthritis

    Christina Charles-Schoeman1, Roy Fleischmann2, Jean Davignon3, Howard Schwartz4, Scott Turner5, Carine Beysen5, Mark Milad6, Zheng Luo7, John Bradley8, Irina Kaplan8, Richard Riese7, Andrea Zuckerman7 and Iain B. McInnes9, 1University of California, Los Angeles, CA, 2Metroplex Clinical Research Center, Dallas, TX, 3University of Montreal, Montreal, Canada, 4Miami Research Associates, Miami, FL, 5KineMed Inc., Emeryville, CA, 6Milad Pharmaceutical Consulting LLC, Plymouth, MI, 7Pfizer Inc., Groton, CT, 8Pfizer Inc, Groton, CT, 9Institute of Infection, Immunity and Inflammation, College of Medical, Veterinary and Life Sciences, University of Glasgow, Glasgow, United Kingdom

    Background/Purpose: Tofacitinib is a novel oral Janus kinase inhibitor being investigated as a targeted immunomodulator and disease-modifying therapy for RA. In RA patients (pts), suppression…
  • Abstract Number: 1291 • 2012 ACR/ARHP Annual Meeting

    A Phase Ib Clinical Trial with F8-IL10, an Anti-Inflammatory Immunocytokine for the Treatment of Rheumatoid Arthritis (RA), Used in Combination with Methotrexate (MTX)

    Mauro Galeazzi1, Caterina Baldi1, Elena Prisco2, Marco Bardelli1, Dario Neri3, Leonardo Giovannoni4, Enrico Selvi1 and Roberto Caporali2, 1Rheumatology, University of Siena, Siena, Italy, 2Rheumatology, University of Pavia, IRCCS Policlinico San Matteo Foundation, Pavia, Italy, 3Chemistry and Applied Biosciences, Swiss Federal Institute of Technology Zurich, Zurich, Switzerland, 4Philogen S.p.A., Siena, Italy

    Background/Purpose: Interleukin 10 (IL10) is an anti-inflammatory cytokine potentially efficacious for RA. F8-IL10 is a fusion protein in which the cytokine is fused with the…
  • Abstract Number: 1292 • 2012 ACR/ARHP Annual Meeting

    Fatigue Is an Independent Variable Predicting Physical Function and Disease Activity Score-28 Remission for Patients with Rheumatoid Arthritis Treated with Intravenously Administered Golimumab: Results From Phase 3, Placebo Controlled Clinical Trial

    Rene Westhovens1, Michael Weinblatt2, Chenglong Han3, Tim Gathany4, Lilianne Kim5, Michael Mack6, Jiandong Lu6, Daniel Baker7, Alan Mendelsohn7 and Clifton O. Bingham III8, 1Rheumatology, University Hospital KU Leuven, Leuven, Belgium, 2Rheumatology & Immunology, Brigham & Women's Hospital, Boston, MA, 3Outcomes Research, Johnson & Johnson Pharmaceutical Services, LLC, Malvern, PA, 4Janssen Global Services, LLC., Malvern, PA, 5Janssen Research & Development, a division of Pharmaceutical Research & Development LLC, Janssen Research & Development, LLC, Malvern, PA, 6Biostatistics, Janssen Research & Development, LLC., Spring House, PA, 7Immunology, Janssen Research & Development, LLC, Spring House, PA, 8Department of Medicine, Johns Hopkins University, Baltimore, MD

    Background/Purpose: To evaluate the association of fatigue with physical function and disease activity in patients with rheumatoid arthritis (RA), and the impact of treatment with…
  • Abstract Number: 1293 • 2012 ACR/ARHP Annual Meeting

    Importance of Steady-State Trough Concentrations After Intravenous Golimumab with Concomitant Methotrexate in Subjects with Active Rheumatoid Arthritis

    J. H. Leu1, Z. Xu1, C. Hu1, Alan Mendelsohn1, J. Ford1, Hugh M. Davis2 and H. Zhou1, 1Janssen Research and Development, LLC, Spring House, PA, 2Janssen Research & Development, LLC., Spring House, PA

    Background/Purpose: To determine an optimized dosing regimen for IV golimumab in subjects with active RA using population pharmacokinetic (PK) modeling and simulation.  Methods: Two Phase…
  • Abstract Number: 1294 • 2012 ACR/ARHP Annual Meeting

    A Phase Ib Multiple Ascending Dose Study Evaluating Safety, Pharmacokinetics, and Early Clinical Response of Brodalumab (AMG 827), a Human Anti-Interleukin 17 Receptor (IL-17R) Antibody, in Rheumatoid Arthritis

    Melvin A. Churchill1, Luis F. Flores-Suarez2, Daniel J. Wallace3, Kristine Phillips4, Richard W. Martin5, Mario H. Cardiel6, Jeffrey Kaine7, Edgar Bautista8, David H. Salinger9, Erin Stevens9, Christopher B. Russell9 and David A. Martin9, 1Arthritis Center of Nebraska, Lincoln, NE, 2Primary Systemic Vasculitides Clinic, Instituto Nacional de Enfermedades Respiratorias, Mexico City, Mexico, 3Cedars-Sinai Medical Center, Los Angeles, CA, 4Rheumatology, University of Michigan Medical School, Ann Arbor, MI, 5Medicine, Rheumatology, Michigan State University College of Human Medicine, Grand Rapids, MI, 6Research Unit, Hospital, Morelia, Mexico, 7Sarasota Arthritis Research Center, Sarasota, FL, 8Medical Sciences, Amgen, Thousand Oaks, CA, 9Medical Sciences, Amgen, Seattle, WA

    Background/Purpose:   The cytokine IL-17A is an innate inflammatory cytokine implicated in the pathogenesis of several human autoimmune diseases including rheumatoid arthritis (RA).  Brodalumab is…
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