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  • Abstract Number: 1602 • 2016 ACR/ARHP Annual Meeting

    Persistence of Tofacitinib in the Treatment of Rheumatoid Arthritis in Open-Label, Long-Term Extension Studies up to 8 Years

    Janet Pope1, Edward Keystone2, Shahin Jamal3, Lisy Wang4, Lara Fallon5, John Woolcott5, Irina Lazariciu6 and Boulos Haraoui7, 1Western University, London, ON, Canada, 2Mount Sinai Hospital, Toronto, ON, Canada, 3University of British Columbia, Vancouver, BC, Canada, 4Pfizer Inc, Groton, CT, 5Pfizer Canada, Montreal, QC, Canada, 6Quintiles, Saint-Laurent, QC, Canada, 7Institut de Rhumatologie de Montréal, Montreal, QC, Canada

    Background/Purpose: Tofacitinib is an oral JAK inhibitor for the treatment of RA. Open-label, long-term extension (LTE) studies enrolled tofacitinib-treated patients (pts) to evaluate safety and…
  • Abstract Number: 1603 • 2016 ACR/ARHP Annual Meeting

    Clinical Responses to Tocilizumab Analyzed By Serologic Status in Rheumatoid Arthritis

    Laura Cappelli1, J. Lynn Palmer2 and Clifton Bingham III3, 1Medicine/Rheumatology, Johns Hopkins University School of Medicine, Baltimore, MD, 2CORRONA Research Foundation, Phoenix, AZ, 3Johns Hopkins University, Baltimore, MD

    Clinical Responses to Tocilizumab Analyzed by Serologic Status in Rheumatoid Arthritis Background/Purpose: Biologic medications have improved outcomes for patients with rheumatoid arthritis (RA), but little…
  • Abstract Number: 1604 • 2016 ACR/ARHP Annual Meeting

    a First-in-Human Study of CR6086, a New Potent EP4 Prostanoid Receptor Antagonist, Demonstrates Good Safety and Tolerability at Therapeutically Relevant Exposures

    Stefano Persiani1, Carla Manzotti1, Cristina Vitalini1, Giampaolo Giacovelli2, Federica Girolami1, Massimo D'Amato1, Gianfranco Caselli1 and Lucio C. Rovati2,3, 1Rottapharm Biotech, Monza, Italy, 2Clinical Research Department, Rottapharm Biotech, Monza, Italy, 3University of Milano Bicocca, Milano, Italy

    Background/Purpose: CR6086 is a potent and selective antagonist of the prostaglandin EP4 receptor. EP4 receptors have a role in T-cell differentiation and expansion, and thus…
  • Abstract Number: 1605 • 2016 ACR/ARHP Annual Meeting

    Pooled Safety and Efficacy of Sarilumab in Rheumatoid Arthritis Patients 65 Years of Age and Older

    Roy Fleischmann1, Mark C. Genovese2, Janet van Adelsberg3, Erin Mangan4, Melitza Iglesias-Rodriguez5, Deborah Dukovic6 and TWJ Huizinga7, 1Medicine, University of Texas Southwestern Medical Center, Dallas, TX, 2Stanford University Medical Center, Palo Alto, CA, 3Clinical Science, Regeneron Pharmaceuticals, Inc., Tarrytown, NY, 4Regeneron Pharmaceuticals, Inc., Tarrytown, NY, 5Sanofi Genzyme, Cambridge, MA, 6Sanofi Genzyme, Bridgewater, NJ, 7Leiden University Medical Centre, Leiden, Netherlands

    Background/Purpose: Sarilumab is a human mAb blocking the IL-6Rα. Sarilumab (150 or 200 mg every 2 weeks [q2w] subcutaneously) + MTX demonstrated efficacy vs placebo…
  • Abstract Number: 1606 • 2016 ACR/ARHP Annual Meeting

    Metrotexate Treatment Inmunomodulate the Abnormal Cytokine Expression Present in NaïVe Rheumatoid Arthritis Patients

    Jorge Monserrat Sanz1, Ana Maria Gómez Lahoz1, Maria Dolores Sosa Reina1, Cristina Bohórquez Heras2, Atusa Movasat2, Ana Pérez Gómez2, Lucía Ruiz Gutiérrez2, Ana Sánchez Atrio2, Eduardo Cuende Quintana2, M José León2, David Diaz3, Fernando Albarrán Hernández2 and Melchor Alvarez-Mon2,3, 1Medicine and Medical Specialities, Laboratory of Immune System Diseases, Department of Medicine, University of Alcalá, Alcalá de Henares, Madrid, Spain, 2University Hospital Príncipe de Asturias, Immune System Diseases, Rheumatology department, Alcalá de Henares, Madrid, Spain, 3Laboratory of Immune System Diseases, Department of Medicine, University of Alcalá, Alcalá de Henares, Madrid, Spain

    Background/Purpose: Methotrexate (MTX) is the most commonly used DMARD in rheumatoid arthritis (RA) patients. Since the first reports of the efficacy of low-dose MTX in…
  • Abstract Number: 1607 • 2016 ACR/ARHP Annual Meeting

    The Development of a New Anti–Interleukin 6 Blocker for Rheumatoid Arthritis Patients

    Alan Glicklich1, Paul Grayson1, Christophe Blanchetot2, Qing Zhou3 and Anke Kretz-Rommel1, 1Bird Rock Bio, Inc, La Jolla, CA, 2Argenx, Ghent, Belgium, 3Genor BioPharma, Shanghai, China

    Background/Purpose: While interleukin-6 (IL-6) blockade with monoclonal antibodies is an established, clinically validated mechanism for the treatment of rheumatoid arthritis (RA), the need for significant…
  • Abstract Number: 1608 • 2016 ACR/ARHP Annual Meeting

    Lack of Early Change in Disease Activity Score Predicts the Likelihood of Achieving Low Disease Activity at Month 6: Tofacitinib Monotherapy Versus Methotrexate in Methotrexate-Naive Patients with Rheumatoid Arthritis

    Edward Keystone1, Ronald F van Vollenhoven2, Bethanie Wilkinson3, Lara Fallon4, Lie-Ju Hwang5, Douglass Chapman5, Ryan DeMasi5 and Eun Bong Lee6, 1Mount Sinai Hospital, Toronto, ON, Canada, 2Amsterdam Rheumatology and Immunology Center, Amsterdam, Netherlands, 3Pfizer Inc, Groton, CT, 4Pfizer Canada, Montreal, QC, Canada, 5Pfizer Inc, New York, NY, 6Seoul National University, Seoul, Korea, Republic of

    Background/Purpose: Tofacitinib is an oral JAK inhibitor for the treatment of rheumatoid arthritis (RA). Treatment guidelines recommend targeting remission or low disease activity (LDA), herein…
  • Abstract Number: 1609 • 2016 ACR/ARHP Annual Meeting

    Efficacy of Tofacitinib in Patients Who Are Inadequate Responders to Disease-Modifying Antirheumatic Drugs According to Early Versus Late Duration of Rheumatoid Arthritis: Post-Hoc Analysis of Data from Phase 3 Trials

    Stephen Hall1, Peter Nash2, Maureen Rischmueller3, Zirke Wiid4, David Witcombe5, David Gruben6, Ryan DeMasi7 and Tatjana Lukic7, 1Cabrini Medical Centre, Monash University, Melbourne, Australia, 2University of Queensland, Brisbane, Australia, 3The Queen Elizabeth Hospital, Adelaide, Australia, 4Pfizer Australia, Sydney, Australia, 5Pfizer Australia, Sydney, NSW, Australia, 6Pfizer Inc, Groton, CT, 7Pfizer Inc, New York, NY

    Background/Purpose: Tofacitinib is an oral Janus kinase inhibitor for the treatment of RA. This post-hoc analysis of data from Phase 3 studies investigated the efficacy…
  • Abstract Number: 1610 • 2016 ACR/ARHP Annual Meeting

    Safety, Tolerability, and Dose-Dependent Inhibition of T-Cell-Dependent Antibody Response with MEDI4920, a Novel, Engineered CD40L Antagonist: Results of a Single-Ascending Dose Study in Healthy Volunteers

    Marius Albulescu1, Jim Bush2, Firas Almazedi2, Ethan Grant3, Alex Godwood1, Robert Miday4, Krista Arbaugh4, Lisa H. Butler1, Michele Gunsior4, Jing Li5 and David Howe1, 1MedImmune, Cambridge, United Kingdom, 2Covance Clinical Research Unit, Leeds, United Kingdom, 3Translational Medicine, MedImmune, Gaithersburg, MD, 4MedImmune, Gaithersburg, MD, 5MedImmune, Mountain View, CA

    Background/Purpose: The CD40L/CD40 co-stimulatory pathway is important for T-cell-dependent antibody production. Previous clinical programs with intact monoclonal antibodies against CD40L have been discontinued due to…
  • Abstract Number: 1611 • 2016 ACR/ARHP Annual Meeting

    In Vitro Cellular Profiling of Sirukumab, an Anti–IL-6 Cytokine Monoclonal Antibody, Reveals a Distinct Phenotypic Signature Compared to Tocilizumab, an Anti–IL-6 Receptor Monoclonal Antibody

    Konstantia-Maria Chavele1, Debbie Gardner2, Matthew J Loza2, Bidisha Dasgupta2, Martin Sims1, David Shealy2, Juliet Reid1 and Ravi Rao1, 1GSK Medicines Research Centre, Stevenage, Hertfordshire, United Kingdom, 2Janssen Research & Development, LLC, Spring House, PA

    Background/Purpose:  IL-6 plays a central pathogenic role in rheumatoid arthritis (RA). IL-6 signals through a complex of transmembrane IL-6R or soluble IL-6R (sIL-6R) with gp130…
  • Abstract Number: 1612 • 2016 ACR/ARHP Annual Meeting

    Abatacept Targets T Follicular Helper Cells in Patients with Rheumatoid Arthritis

    Shingo Nakayamada1, Satoshi Kubo2, Maiko Yoshikawa2, Yusuke Miyazaki2, Ippei Miyagawa3, Shigeru Iwata4, Kazuhisa Nakano5, Kazuyoshi Saito6,7 and Yoshiya Tanaka8, 1First Department of Internal Medicine, University of Occupational and Environmental Health, Japan, Kitakyushu, Japan, 2The First Department of Internal Medicine, University of Occupational and Environmental Health, Japan, Kitakyushu, Japan, 3University of Occupational and Environmental Health, Japan, Kitakyushu, Japan, 4First Department of Internal Medicine, School of Medicine, University of Occupational and Environmental Health, Japan, Kitakyushu, Japan, 5The First department of Internal Medicine, University of Occupational and Environmental Health, Japan, Kitakyushu, Japan, 6The First Department of Internal Medicine, University of Occupational and Environmental Health, Kitakyushu, Japan, 7First Department of Internal Medicine, University of Occupational and Environmental Health, Japan, KItakyushu, Japan, 8University of Occupational and Environmental Health, Kitakyushu, Japan

    Background/Purpose:  In the pathogenesis of rheumatoid arthritis (RA), T cells can differentiate into functionally distinct subsets, leading to the persistent inflammation and immune abnormality associated…
  • 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…
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