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 Iria^3,4, 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 Mariette^4,5 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 Huppertz^6,7 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. Hyrich^1,3, 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…