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  • Abstract Number: 1305 • 2012 ACR/ARHP Annual Meeting

    Three-Year Follow-up of Rituximab in Rheumatoid Arthritis: Results From the Belgian MIRA (MabThera in Rheumatoid Arthritis) Registry

    Filip De Keyser1, Patrick Durez2, Rene Westhovens3, marie-Joelle Kaiser4 and Ilse Hoffman5, 1Department of Rheumatology, Ghent University Hospital, Ghent, Belgium, 2Pôle de Recherche en Rhumatologie, Institut de Recherche Expérimentale et Clinique, Université Catholique de Louvain, Brussels, Belgium, 3Rheumatology, University Hospital KU Leuven, Leuven, Belgium, 4Rheumatology, Dept Rheumatology, University Hospital Liege, Belgium, Belgium, 5Rheumatology, Dept Rheumatology, GZA St-Augustinus Hospital Antwerp, Belgium, Wilrijk, Belgium

    Background/Purpose: The MIRA registry was set up to collect safety, efficacy and (re)treatment practice data for Belgian RA patients treated with rituximab. Methods:  All rheumatologists…
  • Abstract Number: 1306 • 2012 ACR/ARHP Annual Meeting

    How well  Do Patients with Rheumatoid and Psoriatic Arthritis Tolerate Methotrexate? A Retrospective Review of Discontinuation Data From a Large UK Cohort

    Calum T. Goudie1, John D. Fitzpatrick1, Anshuman P. Malaviya2 and Andrew J. Ostor2, 1University of Cambridge Medical School, Cambridge, United Kingdom, 2Rheumatology Research Unit, Addenbrooke's Hospital, Cambridge, United Kingdom

    Background/Purpose: Due to its efficacy and safety, methotrexate (MTX) has become the first-line disease-modifying drug for rheumatoid (RA) and psoriatic arthritis (PsA). Although  deemed  safe,…
  • Abstract Number: 1307 • 2012 ACR/ARHP Annual Meeting

    Anti-IL-6 Receptor Nanobody (ALX-0061) Seamless “First-in-Human” Phase I/II POC Study in Patients with Active RA On Stable MTX Treatment

    Steven De Bruyn1, Béla Gachályi2, Bernadette Rojkovich3, Slavomir Bruk4, Petr Sramek5, Mariusz Korkosz6, Krzysztof Krause7, Pieter Schoen8, Laura Sargentini-Maier9, Joke D'Artois10, Katrien Verschueren10, Katelijne De Swert10, Gerhard Arold11 and Josefin-Beate Holz12, 1Clinical Development, Ablynx N.V., Zwijnaarde, Belgium, 2Fázis I-es Klinikai Farmakológiai Vizsgálóhely, Péterfy Sándor Utcai Kórház, Budapest, Hungary, 3II. sz. Reumatológiai Osztály, Budai Irgalmasrendi Kórház Kht., Budapest, Hungary, 4Interni oddeleni, Nemocnice Trinec, Trinec, Czech Republic, 5Pharmaceutical Research Associates CZ, Praha, Czech Republic, 6Malopolskie Centrum Medyczne, Krakow, Poland, 7Specjalistyczny im. J. Gromkowskiego, Wojewodzki Szpital, Wroclaw, Poland, 8Project Management, Ablynx N.V., Zwijnaarde, Belgium, 9Pharmacology, Ablynx N.V., Zwijnaarde, Belgium, 10Clinical Development, Ablynx nv, Zwijnaarde, Belgium, 11Medical Affairs, PRA International GmbH, Berlin, Germany, 12Chief Medical Officer, Ablynx N.V., Zwijnaarde, Belgium

    Background/Purpose: ALX-0061 is a 26kD bispecific IL-6R targeting Nanobody® with monovalent binding to IL-6R and serum albumin. It effectively neutralizes IL-6 pathway activity in-vitro and…
  • Abstract Number: 1308 • 2012 ACR/ARHP Annual Meeting

    Opportunistic Infections in Patients with Rheumatoid Arthritis Treated with Rituximab : Data From the Autoimmunity and Rituximab Registry

    Jacques-Eric Gottenberg1, Philippe Ravaud2, Thomas Bardin3, Patrice Cacoub4, Alain G. Cantagrel5, Bernard Combe6, Maxime Dougados7, Rene-Marc Flipo8, Bertrand Godeau9, Loic Guillevin10, Xavier X. Le Loet11, Eric Hachulla12, Thierry Schaeverbeke13, Jean Sibilia14, Isabelle Pane15, Gabriel Baron16 and Xavier Mariette17, 1Rheumatology, Strasbourg University Hospital, Strasbourg, France, 2Epidemiology, Hopital Hotel Dieu, Paris Descartes University, Paris, France, 3Rheumatology, Hôpital Lariboisière, Paris, France, 4Internal Medicine, Assistance Publique-Hôpitaux de Paris, Hopital Pitié-Salpétrière, Paris, France, 5Rheumatology, Place du Docteur Baylac, Toulouse, France, 6Rheumatology, Hopital Lapeyronie, Montpellier, France, 7Rheumatology B Department, Paris-Descartes University, Cochin Hospital, Paris, France, 8Rheumatology, Hopital R Salengro CHRU, Lille, France, 9Internal Medicine, University of Paris, AP-HP, Hôpital Mondor Créteil, Creteil, France, 10Department of Internal Medicine, Referral Center for Rare Autoimmune and Systemic Diseases, Hôpital Cochin, AP–HP, Université Paris Descartes, Paris, France, Paris, France, 11Rheumatology Department, CHU de ROUEN, Rouen, France, 12Department of Internal Medicine, Claude Huriez University Hospital, Lille, France, 13Service de Rhumatologie, Groupe Hospitalier Pellegrin, Bordeaux, France, 14Rheumatology, CHU Hautepierre, Strasbourg, France, 15Hotel Dieu University Hospital Paris, Hotel Dieu University Hospital Paris, Paris, France, 16Epidemiology, Strasbourg, France, 17Rheumatology, Université Paris-Sud, Le Kremlin Bicetre, France

    Background/Purpose: Therapy  with biological agents may be associated with opportunistic infections (OIs). Data on the occurrence of OIs in patients with RA treated with rituximab…
  • Abstract Number: 1309 • 2012 ACR/ARHP Annual Meeting

    Predictive Risk Factors of Serious Infections in RA Patients Treated with Abatacept in Real Life: Results in the Orencia and Rheumatoid Arthritis (ORA) Registry

    Jacques-Eric Gottenberg1, Philippe Ravaud2, Alain G. Cantagrel3, Bernard Combe4, René-Marc Flipo5, Thierry Schaeverbeke6, Eric Houvenagel7, Philippe Gaudin8, Damien Loeuille9, Stephanie Rist10, Maxime Dougados11, Jean Sibilia12, Xavier Le Loet13, Christian Marcelli14, Thomas Bardin15, Isabelle Pane16, Elodie Perrodeau17, Gabriel Baron18 and Xavier Mariette19, 1Rheumatology, Strasbourg University Hospital, Strasbourg, France, 2Epidemiology, Hopital Hotel Dieu, Paris Descartes University, Paris, France, 3Rheumatology, Place du Docteur Baylac, Toulouse, France, 4Rheumatology, Hopital Lapeyronie, Montpellier, France, 5Rheumatology Department, Lille University Hospital, Lille, France, 6Service de Rhumatologie, Groupe Hospitalier Pellegrin, Bordeaux, France, 7Service de Rhumatologie, St Philibert Hospital, Lomme 59462, France, 8Rheumatology Department, CHU Hôpital Sud, Grenoble Teaching Hospital, Echirolles, France, 9Rheumatology, CHU Brabois, Vandoeuvre les Nancy, France, 10Hospital University Orléans, France, 11Rheumatology B Department, Paris-Descartes University, APHP, Cochin Hospital, Paris, France, 12Rheumatology, CHU Hautepierre, Strasbourg, France, 13Rheumatology Department, CHU de ROUEN, Rouen, France, 14Rheumatology Department, Caen University Hospital, 15Rheumatology, Hôpital Lariboisière, Paris, France, 16Hotel Dieu University Hospital Paris, Hotel Dieu University Hospital Paris, Paris, France, 17Epidemiologist, Paris, France, 18Hotel Dieu University Hospital Paris, Epidemiology, Paris, France, 19Rheumatology, Université Paris-Sud, Le Kremlin Bicetre, France

    Background/Purpose: Little data is available regarding the rate and predicting factors of serious infections in patients with rheumatoid arthritis treated with abatacept (ABA) in daily…
  • Abstract Number: 1310 • 2012 ACR/ARHP Annual Meeting

    Analysis of Anti-JC Polyomavirus T-Cell Immune Response with JC-Feron in Patients with Rheumatoid Arthritis Treated with Rituximab or Anti-TNF

    Raphaèle Seror1, Houria Chavez2, anne-Aurélie Mazet3, Jeremie Sellam4, Bruno Fautrel5, Maxime Dougados6, Yassine Taoufik2 and Xavier Mariette7, 1Rheumatology, Bicetre university hospital, LE Kremlin-Bicetre, France, 2Biologic Immunology, Hopital Bicetre, Université Paris Sud, AP-HP, Kremlin Bicetre, France, 3Virology, Bicetre university hospital, LE Kremlin-Bicetre, France, 4Rheumatology, Hopital Saint-Antoine, Pierre et Marie Curie University Paris 6, AP-HP, 75012, France, 5Rheumatology / GRC08-EEMOIS, APHP-Pitie Salpetriere Hospital / UPMC, Paris, France, 6Rheumatology B Department, Paris-Descartes University, APHP, Cochin Hospital, Paris, France, 7Rheumatology, Université Paris-Sud, Le Kremlin Bicetre, France

    Background/Purpose: Some cases of progressive multifocal leukoencephalopathy (PML) have been described in patients with autoimmune diseases with profound immunosuppression, due to replication of JC polyomavirus…
  • Abstract Number: 1311 • 2012 ACR/ARHP Annual Meeting

    A Novel Individualized Treatment Approach in Open-Label Extension Study of Ozoralizumab (ATN-103) in Subjects with Rheumatoid Arthritis On a Background of Methotrexate

    Roy Fleischmann1, Steven De Bruyn2, Christian Duby2, Katrien Verschueren3, Judith Baumeister4, Laura Sargentini-Maier5, Cedric Ververken6 and Josefin-Beate Holz7, 1Southwestern Medical Center at Dallas, University of Texas, Dallas, TX, 2Clinical Development, Ablynx N.V., Zwijnaarde, Belgium, 3Clinical Development, Ablynx nv, Zwijnaarde, Belgium, 4Department of Pharmacology, Ablynx N.V., Zwijnaarde, Belgium, 5Pharmacology, Ablynx N.V., Zwijnaarde, Belgium, 6Project Management, Ablynx N.V., Zwijnaarde, Belgium, 7Chief Medical Officer, Ablynx N.V., Zwijnaarde, Belgium

    Background/Purpose: Ozoralizumab (ATN-103), a novel TNFα inhibitor, is a trivalent, bispecific Nanobody® that potently neutralises TNF and binds to human serum albumin to increase its…
  • Abstract Number: 1312 • 2012 ACR/ARHP Annual Meeting

    Clinical Response At 12 Weeks Predicts Long-Term Remission and the Extent of Radiographic Progression in Japanese Patients with Rheumatoid Arthritis Treated with Certolizumab Pegol with and without Methotrexate Coadministration

    Tsutomu Takeuchi1, Kazuhiko Yamamoto2, Hisashi Yamanaka3, Naoki Ishiguro4, Yoshiya Tanaka5, Katsumi Eguchi6, Akira Watanabe7, Hideki Origasa8, Toshiharu Shoji9, Nobuyuki Miyasaka10 and Takao Koike11, 1Keio University School of Medicine, Tokyo, Japan, 2Department of Allergy & Rheumatology, Graduate School of Medicine, The University of Tokyo, Bunkyo-ku, Tokyo, Japan, 3Institute of Rheumatology, Tokyo Women's Medical University, Tokyo, Japan, 4Department of Orthopedic Surgery, Nagoya University, Graduate School & Faculty of Medicine, Nagoya, Aichi, Japan, 5The First Department of Internal Medicine, University of Occupational and Environmental Health, Japan, Kitakyushu, Japan, 6Sasebo City General Hospital, Sasebo, Nagasaki, Japan, 7Research Division for Development of Anti-Infectious Agents, Institute of Development, Aging and Cancer, Tohoku University, Sendai, Miyagi, Japan, 8Division of Biostatistics and Clinical Epidemiology, University of Toyama School of Medicine, Toyama, Toyama, Japan, 9Department of Clinical Research and Development, Otsuka Pharmaceutical Co., Ltd, Shinagawa-ku, Tokyo, Japan, 10Department of Medicine and Rheumatology and Global Center of Excellence Program, Tokyo Medical and Dental University, Tokyo, Japan, 11Sapporo medical center NTT EC, Sapporo, Japan

    Background/Purpose: The majority of patients (pts) with active rheumatoid arthritis (RA) have previously been shown to respond during the first 12 weeks (wks)  of certolizumab…
  • Abstract Number: 1313 • 2012 ACR/ARHP Annual Meeting

    Tolerance of Rituximab in Patients with a History of Cancer : Data From the Registry Air

    Jacques-Eric Gottenberg1, Marie-Odile Duzanski2, Thomas Bardin3, Patrice Cacoub4, Alain G. Cantagrel5, Bernard Combe6, Maxime Dougados7, Rene-Marc Flipo8, Bertrand Godeau9, Loic Guillevin10, Eric Hachulla11, Xavier Le Loet12, Thierry Schaeverbeke13, Jean Sibilia14, Isabelle Pane15, Philippe Ravaud16, Gabriel Baron17 and Xavier Mariette18, 1Rheumatology, Strasbourg University Hospital, Strasbourg, France, 2Service Pharmacie - Hôpital de Hautepierre, Hôpitaux Universitaires de Strasbourg, Strasbourg, France, 3Rheumatology, Hôpital Lariboisière, Paris, France, 4Internal Medicine, Assistance Publique-Hôpitaux de Paris, Hopital Pitié-Salpétrière, Paris, France, 5Dept of Rheumatology, Hopital Purpan, Toulouse CEDEX 9, France, 6Rheumatology, Hopital Lapeyronie, Montpellier, France, 7Rheumatology B Department, Paris-Descartes University, APHP, Cochin Hospital, Paris, France, 8Rheumatology, Hopital R Salengro CHRU, Lille, France, 9Internal Medicine, University of Paris, AP-HP, Hôpital Mondor Créteil, Creteil, France, 10Department of Internal Medicine, Referral Center for Rare Autoimmune and Systemic Diseases, Hôpital Cochin, AP–HP, Université Paris Descartes, Paris, France, Paris, France, 11Department of Internal Medicine, Claude Huriez University Hospital, Lille, France, 12Rheumatology Department, CHU de ROUEN, Rouen, France, 13Service de Rhumatologie, Groupe Hospitalier Pellegrin, Bordeaux, France, 14Rheumatology, CHU Hautepierre, Strasbourg, France, 15Hotel Dieu University Hospital Paris, Hotel Dieu University Hospital Paris, Paris, France, 16Epidemiology, Hopital Hotel Dieu, Paris Descartes University, Paris, France, 17Hotel Dieu University Hospital Paris, Epidemiology, Paris, France, 18Rheumatology, Université Paris-Sud, Le Kremlin Bicetre, France

    Background/Purpose: Data regarding tolerance of biologics in patients with a history of cancer are very limited. We therefore analyzed tolerance of rituximab (RTX) in patients…
  • Abstract Number: 1314 • 2012 ACR/ARHP Annual Meeting

    Validation of Algorithms Using Genome-Wide SNP Analysis for Prediction of Remission or Low Disease Activity for Infliximab or Etanercept-Treated RA Patients

    Tsukasa Matsubara1, Satoru Koyano2, Keiko Funahashi2, James E. Middleton2, Takako Miura1, Kosuke Okuda1, Takeshi Nakamura1, Akira Sagawa3, Takeo Sakurai4, Hiroaki Matsuno5, Tomomaro Izumihara6, Eisuke Shono7, Kou Katayama8, Toyomitsu Tsuchida9, Mitsuyoshi Iwahashi10, Tomomi Tsuru11 and Motohiro Oribe12, 1Matsubara Mayflower Hospital, Kato, Japan, 2Research Institute of Joint Diseases, Kobe, Japan, 3Sagawa Akira Rheumatology Clinic, Sapporo, Japan, 4Inoue Hospital, Takasaki, Japan, 5Matsuno Clinic for Rheumatic Diseases, Toyama, Japan, 6Izumihara Rheumatic and Medical Clinic, Kagoshima, Japan, 7Shono Rheumatology Clinic, Fukuoka, Japan, 8Katayama Orthopedic Rheumatology Clinic, Asahikawa, Japan, 9Tsuchida Clinic, Chiba, Japan, 10Higashi-Hiroshima Memorial Hospital, Higashi-hiroshima, Japan, 11PS Clinic, Fukuoka, Japan, 12Oribe Rheumatism and Internal Medicine Clinic, Oita, Japan

    Background/Purpose: Achievement of remission or low disease activity with infliximab (IFX) and etanercept (ETN) treatment is currently one of the most important matters in RA…
  • Abstract Number: 1315 • 2012 ACR/ARHP Annual Meeting

    Gene Expression Profiling and Pathway Changes Associated with Clinical Response to Tabalumab Blockade of Membrane Bound and Soluble B Cell Activating Factor in Rheumatoid Arthritis

    Wendy J. Komocsar1, Mark C. Genovese2, Ernst R. Dow3, Poulabi Banerjee1, Michelle A. Penny3, Eric P. Nantz1, Sergey Stepaniants4, Anne Ho4, Pierre-Yves Berclaz1 and Robert W. Hoffman1, 1Eli Lilly and Company, Indianapolis, IN, 2Division of Rheumatology, Stanford University, Palo Alto, CA, 3Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN, 4Covance Genomics Laboratory LLC, Seattle, WA

    Background/Purpose: Tabalumab, a monoclonal antibody neutralizing membrane bound and soluble B cell activating Factor (BAFF), has been shown to reduce the signs and symptoms of…
  • Abstract Number: 1276 • 2012 ACR/ARHP Annual Meeting

    Changes in B Cell Populations and Serum Immunoglobulins and Their Relationship to Infections in a One Year, Uncontrolled Open Label Study of Tabalumab

    Maria W. Greenwald1, Melissa Veenhuizen2, Wendy Komocsar3, Rebecca Jones-Taha4, Chin H. Lee3 and Pierre-Yves Berclaz3, 1Desert Medical Advances, Palm Desert, CA, 2Eli Lilly and Company, Indianapolis, IN, 3Eli Lilly & Company, Indianapolis, IN, 4PharmaNet/i3, Blue Bell, PA

    Background/Purpose: B cell activating factor (BAFF) is an important modulator of B cell development and proliferation and is secreted by neutrophils, monocytes, macrophages and dendritic…
  • Abstract Number: 1277 • 2012 ACR/ARHP Annual Meeting

    Tofacitinib, an Oral Janus Kinase Inhibitor, in Combination with Methotrexate Reduced the Progression of Structural Damage in Patients with Rheumatoid Arthritis: Year 2 Efficacy and Safety Results From a 24-Month Phase 3 Study

    D. van der Heijde1, Y. Tanaka2, Roy Fleischmann3, Edward Keystone4, Joel M. Kremer5, C. Zerbini6, M. H. Cardiel7, S. B. Cohen8, P. T. Nash9, Y. Song10, D. Tegzova11, B. Wyman12, D. Gruben12, B. Benda13, G. Wallenstein14, S. Krishnaswami12, S. H. Zwillich12, J. Bradley15, C. A. Connell16 and ORAL Scan Investigators17, 1Rheumatology, Leiden University Medical Center, Leiden, Netherlands, 2University of Occupational and Environmental Health, Kitakyushu, Japan, 3Metroplex Clinical Research Center, Dallas, TX, 4Rebecca MacDonald Centre for Arthritis and Autoimmune Disease, Mount Sinai Hospital, Toronto, ON, Canada, 5The Center for Rheumatology, Albany Medical College, Albany, NY, 6CEPIC – Centro Paulista de Investigação Clínica, São Paulo-SP, Sao Paulo, Brazil, 7Centro de Investigacion Clinica de Morelia, Morelia, Mexico, 8Metroplex Clinical Research Centre, Dallas, TX, 9Rheumatology Research Unit, Nambour Hospital, Sunshine Coast, Australia, 10Department of Internal Medicine, Seoul National University Hospital, Seoul, South Korea, 11Institute of Rheumatology, Prague, Czech Republic, 12Pfizer Inc., Groton, CT, 13Clinical Development & Medical Affairs, Pfizer Inc., Collegeville, PA, 14Pfizer Inc, New York, NY, 15Worldwide Pharmaceutical Development, Pfizer Inc., Groton, CT, 16Pfizer Inc, Groton, CT, 17Groton

    Background/Purpose: Tofacitinib is a novel, oral Janus kinase inhibitor being investigated as a targeted immunomodulator and disease-modifying therapy for RA. This 24‑month (Mo) Phase 3…
  • Abstract Number: 1278 • 2012 ACR/ARHP Annual Meeting

    Tuberculosis and Tofacitinib Therapy in Patients with Rheumatoid Arthritis

    Kevin L. Winthrop1, S.-H. Park2, A. Gul3, M. Cardiel4, JJ Gomez-Reino5, D. Ponce de Leon6, R. Riese7, R. Chew7, T. Kawabata7, E. Mortensen6 and H. Valdez8, 1Dept of Infectious Disease, Oregon Health & Science University, Portland, OR, 2The Catholic University of Korea, Seoul, South Korea, 3Istanbul University, Istanbul, Turkey, 4Centro de Investigación Clínica de Morelia SC, Morelia, Mexico, 5Hospital Clinico Universitario de Santiago, Santiago de Compostela, Spain, 6Pfizer Inc., Collegeville, PA, 7Pfizer Inc., Groton, CT, 8Pfizer Inc., New York, NY

    Background/Purpose: Biologic therapies that block tumor necrosis factor-alpha (TNF) increase the risk of tuberculosis (TB), and screening for latent tuberculosis infection (LTBI) before their initiation…
  • Abstract Number: 1279 • 2012 ACR/ARHP Annual Meeting

    First in Human Study with Recombinant Anti-IL-21 Monoclonal Antibody in Healthy Subjects and Patients with Rheumatoid Arthritis

    Stanislav Ignatenko1, Birte K. Skrumsager2, Adam Steensberg3 and Ulrik Mouritzen3, 1Charité Research Organization GmbH, Berlin, Germany, 2Clinical Pharmacology Biopharm, Novo Nordisk A/S, Copenhagen, Denmark, 3Medical & Science, Inflammation, Novo Nordisk A/S, Copenhagen, Denmark

    Background/Purpose: Interleukin-21 (IL-21), a cytokine produced by activated T cells (especially T17 and TFH cells), has a proinflammatory and pleiotropic nature, and drives mainly activation…
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