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Abstracts tagged "Biologic drugs"

  • Abstract Number: 700 • 2018 ACR/ARHP Annual Meeting

    Immunogenicity of Originator and Biosimilar Infliximab: Anti-Drug Antibody Occurence, Cross-Reactivity and Epitope Specificities across Six Diseases. Analyses from a Norwegian Randomized Switching Trial

    Guro Løvik Goll1, Nils Bolstad2, Ines Iria3,4, Rolf Klaasen5, Kristin Kaasen Jørgensen6, Inge C Olsen7, Ana Valido8, Maria J Saavedra9, João E. Fonseca10, Merete Lorentzen11, Cato Mork12, Knut EA Lundin13, David J Warren14, Espen A. Haavardsholm15, Jorgen Jahnsen16, Tore Kvien15 and João Gonçalves17, 1Department of Rheumathology, Diakonhjemmet Hospital, Oslo, Norway, 2Department of Medical Biochemistry,, OUS-Radiumhospitalet, Oslo, Norway, 3Dept Pharmacology, Faculdade de Farmacia da Universidade de Lisboa, Lisbon, Portugal, 4iMed- Research Institute for medicines, Lisbon, Portugal, 5Dartment of Medical Biochemistry, OUS-Radiumhospitalet, Oslo, Norway, 6Dept Gastroenterology, Akershus University Hospital, Lørenskog, Norway, 7Department of Rheumatology, Diakonhjemmet Hospital, Oslo, Norway, 8Rheumatology, Centro Hospitalar Lisboa Norte, Lisbon, Portugal, 9Rheumatology and Metabolic Bone Diseases, Hospital de Santa Maria, CHLN, Lisbon, Portugal, 10Serviço de Reumatologia e Doenças Ósseas Metabólicas, Hospital de Santa Maria, CHLN, Instituto de Medicina Molecular, Faculdade de Medicina da Universidade de Lisboa, Lisbon, Portugal, 11Dept of Dermatology, Rikshospitalet, Oslo, Norway, 12Dept of Cancer Research and Molecular Medicine, Norwegian University of Science and Technology, Trondheim, Norway, 13Dept of gastroenterology, Oslo University Hospital, Oslo, Norway, 14Department of Medical Biochemistry, OUS-Radiumhospitalet, Oslo, Norway, 15Dept. of Rheumatology, Diakonhjemmet Hospital, Oslo, Norway, 16Dept of Gastroenterology, Akershus University Hospital, Lørenskog, Norway, 17Research Institute for Medicines (iMed.ULisboa), Faculty of Pharmacy, Universidade de Lisboa, Lisboa, Portugal

    Background/Purpose: The NOR-SWITCH study was funded by the Norwegian government to investigate switching from originator infliximab (INX) to biosimilar CT-P13, in spondyloarthritis (SpA), rheumatoid arthritis…
  • Abstract Number: 2385 • 2018 ACR/ARHP Annual Meeting

    The Childhood Arthritis and Rheumatology Research Alliance Start Time Optimization of Biologic Therapy in Polyarticular JIA Study: Updated Report of Baseline Patient Characteristics and Treatment Choices

    Sarah Ringold1, George A. Tomlinson2, Pamela F. Weiss3, Laura E. Schanberg4, Mary Ellen Riordan5, Anne C. Dennos6, Vincent Del Gaizo7, Katherine Murphy8, Brian M. Feldman9 and Yukiko Kimura5, 1Pediatric Rheumatology, Seattle Children's Hospital, Seattle, WA, 2Institute for Health Policy, Management and Evaluation, University of Toronto, Toronto, ON, Canada, 3Division of Rheumatology, Center for Pediatric Clinical Effectiveness, Children's Hospital of Philadelphia, Philadelphia, PA, 4Duke University Medical Center, Durham, NC, 5Hackensack University Medical Center, Hackensack, NJ, 6Duke Clinical Research Institute, Durham, NC, 7Parent Partner, Whitehouse Station, NJ, 8Parent Partner, San Francisco, CA, 9Rheumatology, The Hospital for Sick Children, Toronto, ON, Canada

    Background/Purpose: There is significant variation in the timing of when biologic medications are started during initial treatment for polyarticular juvenile idiopathic arthritis (P-JIA) in clinical…
  • Abstract Number: 703 • 2018 ACR/ARHP Annual Meeting

    Articular Manifestations in Patients with Inflammatory Bowel Disease Treated with Vedolizumab

    Anastasia Dupré1, Michael Collins2, Franck Carbonnel3, Xavier Mariette4,5 and Raphaele Seror1, 1Hopitaux Universitaires Paris Sud, Kremlin Bicetre, France, Rheumatology, Université Paris Sud, Le Kremlin Bicetre, France, 2Hopitaux Universitaires Paris Sud, Kremlin Bicetre, France, Gastro-Enterology, Université Paris Sud, Le Kremlin Bicêtre, France, 3Hopitaux Universitaires Paris Sud, Kremlin Bicetre, France, Gastro-enterology, Université Paris Sud, Le Kremlin Bicêtre, France, 4Rheumatology department, Center for Immunology of Viral Infections and Autoimmune Diseases, Assistance Publique- Hôpitaux de Paris, Hôpitaux Universitaires Paris-Sud, Le Kremlin-Bicêtre, Université Paris Sud, INSERM, Paris, Paris, France, 5Immunology of viral Infections and Autoimmune Diseases, IDMIT, CEA - Université Paris Sud - INSERM U1184, Le Kremlin Bicêtre & Fontenay aux Roses, France

    Background/Purpose: Vedolizumab is a humanised IgG1 monoclonal antibody anti-α4β7 integrin agent used in inflammatory bowel disease (IBD). It modulates gut inflammation by preventing leukocyte migration…
  • Abstract Number: 2509 • 2018 ACR/ARHP Annual Meeting

    Long-Term Treatment with Sarilumab Plus Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs): Pooled Safety and Efficacy with over 4 Years’ Treatment

    Mark C. Genovese1, Hubert van Hoogstraten2, Gregory St. John3, Qunming Dong2, Juan José Gómez-Reino4, José A. Maldonado-Cocco5, Juan Carlos Salazar6, Tom W.J. Huizinga7 and Gerd R. Burmester8, 1Stanford University Medical Center, Palo Alto, CA, 2Sanofi Genzyme, Bridgewater, NJ, 3Regeneron Pharmaceuticals, Inc., Tarrytown, NY, 4Complejo Hospitalario Universitario de Santiago de Compostela, Santiago, Spain, 5School of Medicine, Buenos Aires University, Buenos Aires, Argentina, 6Riesgo de Fractura S.A - CAYRE, Bogotá, Colombia, 7Leiden University Medical Center, Leiden, Netherlands, 8Charité – University Medicine Berlin, Berlin, Germany

    Background/Purpose: EXTEND (NCT01146652) is an ongoing open-label extension study enrolling patients completing five sarilumab originator studies (MOBILITY [NCT01061736]; TARGET [NCT01709578]; ASCERTAIN [NCT01768572]; ACT11575 [NCT01217814]; ONE…
  • Abstract Number: 960 • 2018 ACR/ARHP Annual Meeting

    The Risk of Gastrointestinal Perforations Associated with Biologic Disease-Modifying Anti-Rheumatic Drugs Used in Rheumatoid Arthritis: A Nationwide Swedish Cohort Study

    Andrei Barbulescu1, Thomas Frisell1, Johan Askling2 and Bénédicte Delcoigne1, 1Clinical Epidemiology Unit, Department of Medicine, Solna, Karolinska Institutet, Stockholm, Sweden, 2Unit of Clinical Epidemiology, Department of Medicine, Solna, Karolinska Institutet, Stockholm, Sweden

    Background/Purpose: Gastrointestinal (GI) perforations occur more often than expected in patients with RA. Reports indicate that tocilizumab may be associated with an increased risk of…
  • Abstract Number: 2527 • 2018 ACR/ARHP Annual Meeting

    Long-Term Safety with Sarilumab Plus Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) and Sarilumab Monotherapy in Rheumatoid Arthritis (RA): An Integrated Analysis with 9,000 Patient-Years (Pt-Yrs) of Follow-up

    Roy Fleischmann1, Yong Lin2, Gregory St. John3, Désirée van der Heijde4, Chunfu Qiu2, Juan José Gómez-Reino5, José A. Maldonado-Cocco6, Marina Stanislav7, Bruno Seriolo8 and Gerd R. Burmester9, 1University of Texas Southwestern Medical Center, Dallas, TX, 2Sanofi Genzyme, Bridgewater, NJ, 3Regeneron Pharmaceuticals, Inc., Tarrytown, NY, 4Leiden University Medical Centre, Leiden, Netherlands, 5IDIS, Complejo Hospitalario Universitario de Santiago, Santiago, Spain, 6School of Medicine, Buenos Aires University, Buenos Aires, Argentina, 7Research Rheumatology Institute n. a. V.A. Nassonova, Moscow, Russian Federation, 8Department of Internal Medicine, University of Genova, Genova, Italy, 9Charité – University Medicine Berlin, Berlin, Germany

    Background/Purpose: Sarilumab has shown efficacy in RA both as monotherapy and in combination with csDMARDs in Phase 3 trials. We assessed long-term safety from the…
  • Abstract Number: 978 • 2018 ACR/ARHP Annual Meeting

    Treat-to-Target Study for Improved Outcome in Polyarticular Juvenile Idiopathic Arthritis

    Gerd Horneff1, Ivan Foeldvari2, Ralf Trauzeddel3, Toni Hospach4, Kirsten Minden5, Hans-Iko Huppertz6,7 and Ariane Klein8, 1Asklepios Klinik Zentrum für Allgemeine Paediatrie und Neonatologie, Sankt Augustin, Germany, 2Hamburger Zentrum fur, Kinder-und Jugendrheumatologie, Hamburg, Germany, 3Helios Clinics, Berlin, Germany, 4Pediatrics, Olgahospital, Klinikum Stuttgart, Stuttgart, Germany, 5Charité–Universitätsmedizin Berlin, Berlin, Germany, 6Prof Hess Clinic, Bremen, Germany, 7Prof. Hess Childrens Hospital, Bremen, Germany, 8Center of Pediatrics and Neonatology, Asklepios Clinic Sankt Augustin, Sankt Augustin, Germany

    Background/Purpose: Juvenile idiopathic arthritis (JIA) is one of the most prevalent chronic diseases of childhood and adolescence. Evidence suggests that early effective treatment is important…
  • Abstract Number: 2529 • 2018 ACR/ARHP Annual Meeting

    Liver Function Test Levels with Sarilumab Treatment in Phase 3 Trials: Analysis By Baseline Liver Function Test (LFT) Level

    John Tesser1, Gregory St. John2, Toshio Kimura2, Stefano Fiore3, Maureen Rischmueller4, José A. Maldonado-Cocco5, Jürgen Braun6 and Jeffrey Kaine7, 1Arizona Arthritis & Rheumatology Associates, Glendale, AZ, 2Regeneron Pharmaceuticals, Inc., Tarrytown, NY, 3Clinical Science, Sanofi Genzyme, Bridgewater, NJ, 4The University of Adelaide, Adelaide, Australia, 5Buenos Aires University School of Medicine, Buenos Aires, Argentina, 6Ruhr-University Bochum, Bochum, Germany, 7Sarasota Arthritis Research Center, Sarasota, FL

    Background/Purpose: Sarilumab showed efficacy in RA and superiority to placebo and adalimumab in Phase 3 trials. This post hoc analysis investigated LFT levels in three…
  • Abstract Number: 1511 • 2018 ACR/ARHP Annual Meeting

    The Relationship between Lipid Profile Changes and Inflammation across the Phase 3 Sarilumab Rheumatoid Arthritis (RA) Developmental Program

    Christina Charles-Schoeman1, Gregory St. John2, Henry Leher2, Toshio Kimura2, Hubert van Hoogstraten3, Michael T. Nurmohamed4, Miguel Angel González-Gay5 and Edward C. Keystone6, 1Rheumatology, UCLA David Geffen School of Medicine, Los Angeles, CA, 2Regeneron Pharmaceuticals, Inc., Tarrytown, NY, 3Sanofi Genzyme, Bridgewater, NJ, 4VU University Medical Center, Amsterdam, Netherlands, 5University Hospital Marques de Valdecilla, Santander, Spain, 6University of Toronto and Mount Sinai Hospital, Toronto, ON, Canada

    Background/Purpose: Sarilumab showed superiority to placebo and adalimumab in Phase 3 trials. Serum lipids may be reduced in the setting of chronic inflammation associated with…
  • Abstract Number: 2530 • 2018 ACR/ARHP Annual Meeting

    Uncovering Clinicians’ Gaps and Attitudes Toward Biosimilars: Impact of a 2-Phase Educational Program

    Zachary Schwartz1, Jenny Schulz1, Angelique Vinther1, Alyce Kuklinski1 and Kenneth Saag2, 1Clinical Care Options, Reston, VA, 2University of Alabama at Birmingham, Birmingham, AL

    Background/Purpose: Biosimilar agents have changed the clinical landscape in rheumatology, gastroenterology, and dermatology. We sought to measure clinicians’ competence and knowledge of biosimilars and to…
  • Abstract Number: 1528 • 2018 ACR/ARHP Annual Meeting

    Unique Changes in Hemoglobin with Sarilumab Versus Adalimumab Are Independent of Better Disease Control in Patients with Rheumatoid Arthritis (RA)

    Gerd R. Burmester1, Owen Hagino2, Qunming Dong3, Marina Stanislav4, Antonio Gomez-Centeno5, Carlo Selmi6, Tom W.J. Huizinga7, Erin Mangan8, Cem Gabay9 and Mark C. Genovese10, 1Charité – University Medicine Berlin, Free University and Humboldt University Berlin, Berlin, Germany, 2Sanofi Genzyme, Bridgewater, NJ, 3Sanofi, Bridgewater, NJ, 4Scientific Research Institute of Rheumatology, Russian Academy of Medical Sciences, Moscow, Russian Federation, 5Corporació Sanitària Parc Taulí, Barcelona, Spain, 6Rheumatology and Clinical Immunology Unit, Humanitas Research Hospital, Rozzano (MI), Italy, 7Leiden University Medical Center, Leiden, Netherlands, 8Regeneron Pharmaceuticals, Inc., Tarrytown, NY, 9University Hospitals of Geneva, Geneva, Switzerland, 10Stanford University Medical Center, Palo Alto, CA

    Background/Purpose: Anemia (WHO criteria: Hemoglobin [Hb] levels <12.0 g/dL [females] or <13.0 g/dL [males]) is a common finding associated with increased joint inflammation in patients…
  • Abstract Number: 2539 • 2018 ACR/ARHP Annual Meeting

    SB4 Shows Comparable Short-Term Effectiveness to Its Etanercept Originator As First-Line Biologic Treatment for Patients with Rheumatoid Arthritis in Routine Clinical Care

    Diederik De Cock1, Lianne Kearsley-Fleet2, Rebecca Davies2, Kath Watson2 and Kimme L. Hyrich1,3, 1Arthritis Research UK Centre for Epidemiology, The University of Manchester, Manchester, United Kingdom, 2Arthritis Research UK Centre for Epidemiology, The University of Manchester, Manchester Academic Health Science Centre, Manchester, United Kingdom, 3National Institute of Health Research Manchester Biomedical Research Centre, Manchester University NHS Foundation Trust, Manchester Academic Health Science Centre, Manchester, United Kingdom

    Background/Purpose: In the United Kingdom (UK) since 2016, etanercept biosimilars (SB4) are since 2016 a first-line treatment option for the management of severe rheumatoid arthritis…
  • Abstract Number: 1533 • 2018 ACR/ARHP Annual Meeting

    Simulating Population Disability Outcomes for Alternative Treatment Pathways in Patients with Active Rheumatoid Arthritis

    Josephine Mauskopf1, Mahdi Gharaibeh2, David Wamble1, David H. Collier2, Bradley S. Stolshek2 and Eric L. Matteson3, 1RTI Health Solutions, Research Triangle Park, NC, 2Amgen Inc., Thousand Oaks, CA, 3Division of Rheumatology, Mayo Clinic College of Medicine and Science, Rochester, MN

    Background/Purpose:  Rheumatoid arthritis (RA) is a chronic, systemic inflammatory disorder that causes joint pain and swelling, bone erosions, and deformity.  This debilitating disease can severely…
  • Abstract Number: 2559 • 2018 ACR/ARHP Annual Meeting

    Efficacy and Safety of Ixekizumab in Patients with Active Psoriatic Arthritis and Previous Inadequate Response to TNF Inhibitors: Two-Year Follow-up from a Phase 3 Study

    Ana-Maria Orbai1, Amanda M. Gellett2, Lisa Kerr2 and Arnaud Constantin3, 1Johns Hopkins University School of Medicine, Baltimore, MD, 2Eli Lilly and Company, Indianapolis, IN, 3Hopital Pierre-Paul Riquet, Toulouse, France

    Background/Purpose: Ixekizumab (IXE), a high-affinity monoclonal antibody that selectively targets IL-17A, was superior to placebo (PBO) at Week (Wk) 24 for treating PsA signs and…
  • Abstract Number: 1534 • 2018 ACR/ARHP Annual Meeting

    Comparative Risk of Diabetes Mellitus in Rheumatoid Arthritis Patients Treated with Different Biologics- a Cohort Study

    Rishi J. Desai1, Sara Dejene2, Yinzhu Jin2, Jun Liu3 and Seoyoung C. Kim2, 1Division of Pharmacoepidemiology and Pharmacoeconimics, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, 2Brigham and Women's Hospital, Boston, MA, 3Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women's Hospital, Boston, MA

    Background/Purpose: Patients with rheumatoid arthritis (RA) often develop diabetes mellitus (DM), potentially due to aggravated systemic inflammation. Reducing inflammation with disease-modifying antirheumatic drugs (DMARD) may…
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