Abstracts tagged "Biologic drugs"

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…
Abstract Number: 2596 • 2018 ACR/ARHP Annual Meeting
Real-World Long-Term Effectiveness of Switching between Tumor Necrosis Factor Inhibitors in Psoriatic Arthritis Patients from the Rheumatic Diseases Portuguese Register
Elsa Vieira-Sousa^1,2, Mónica Eusébio³, Pedro Ávila-Ribeiro^1,2, Nikita Khmelinskii^1,2, Ana Rita Machado^1,2, Teresa Martins-Rocha^4,5, Miguel Bernardes^4,5, Daniela Santos Faria⁶, Joana Leite Silva⁶, Helena Santos⁷, Cláudia Miguel⁷, Pedro Carvalho^8,9, Tiago Costa¹⁰, Lídia Teixeira¹¹, Tiago Meirinhos¹², Patrícia Nero¹³ and Maria José Santos^11,14, ¹Serviço de Reumatologia e Doenças Ósseas Metabólicas, Hospital de Santa Maria, Centro Hospitalar Lisboa Norte, Lisboa, Portugal, Lisboa, Portugal, ²Unidade de Investigação em Reumatologia, Instituto de Medicina Molecular, Faculdade de Medicina, Universidade de Lisboa, Centro Académico de Medicina de Lisboa, Lisboa, Portugal, Lisboa, Portugal, ³Sociedade Portuguesa de Reumatologia, Lisboa, Portugal, LIsboa, Portugal, ⁴Serviços de Reumatologia do Centro Hospitalar São João do Porto, Porto, Portugal, Porto, Portugal, ⁵Faculdade de Medicina da Universidade do Porto (FMUP), Porto, Portugal, Porto, Portugal, ⁶Serviço de Reumatologia da Unidade Local de Saúde do Alto Minho, Ponte de Lima, Portugal, Ponte de Lima, Portugal, ⁷Instituto Português de Reumatologia Lisboa, Portugal, Lisboa, Portugal, ⁸Serviço de Reumatologia, Hospitais Universitários de Coimbra, Coimbra, Portugal, Coimbra, Portugal, ⁹Serviço de Reumatologia, Centro Hospitalar e Universitário do Algarve, Faro, Portugal, Faro, Portugal, ¹⁰Serviço de Reumatologia do Hospital Egas Moniz, Lisboa, Portugal, Lisboa, Portugal, ¹¹Serviço de Reumatologia do Hospital Garcia de Orta, Almada, Portugal, Almada, Portugal, ¹²Serviço de Reumatologia, Centro Hospitalar do Baixo Vouga, Aveiro, Portugal, Aveiro, Portugal, ¹³Hospital CUF Descobertas, Lisboa, Portugal, Lisboa, Portugal, ¹⁴Sociedade Portuguesa de Reumatologia, Lisboa, Portugal, Lisboa, Portugal
Background/Purpose: Tumor necrosis factor inhibitors (TNFi) lead to a dramatic improvement in the management of psoriatic arthritis (PsA). Nevertheless, a significant proportion of patients…
Abstract Number: 3L • 2017 ACR/ARHP Annual Meeting
Secukinumab Demonstrates Low Radiographic Progression and Sustained Efficacy through 4 Years in Patients with Active Ankylosing Spondylitis
Jürgen Braun¹, Xenofon Baraliakos¹, Atul A. Deodhar², Denis Poddubnyy³, Paul Emery⁴, Evie Maria Delicha⁵, Zsolt Talloczy⁶ and Brian Porter⁶, ¹Rheumazentrum Ruhrgebiet, Herne, and Ruhr University Bochum, Herne, Germany, ²Division of Arthritis & Rheumatic Diseases, Oregon Health & Science University, Portland, OR, ³Department of Rheumatology, Charité Universitätsmedizin Berlin, Berlin, Germany, ⁴Leeds Musculoskeletal Biomedical Research Unit/Institute Rheumatic and Musculoskeletal Medicine, Leeds, United Kingdom, ⁵Novartis Pharma AG, Basel, Switzerland, ⁶Novartis Pharmaceuticals Corporation, East Hanover, NJ

Background/Purpose: Secukinumab, a fully human anti–interleukin-17A monoclonal antibody, reported improved signs and symptoms of ankylosing spondylitis (AS) in the MEASURE 1 trial.1 Here, we report…
Abstract Number: 842 • 2017 ACR/ARHP Annual Meeting
Risk of Serious Infection in Patients with Rheumatoid Arthritis Treated with Biologic Vs. Non-Biologic Dmards
Gulsen Ozen¹, Sofia Pedro², Bryant R. England³, Bella Mehta⁴, Frederick Wolfe² and Kaleb Michaud¹, ¹Rheumatology, University of Nebraska Medical Center, Omaha, NE, ²National Data Bank for Rheumatic Diseases, Wichita, KS, ³Division of Rheumatology & Immunology, Department of Internal Medicine, Nebraska-Western IA VA Health Care System & University of Nebraska Medical Center, Omaha, NE, ⁴Rheumatology, Hospital for Special Surgery/Weill Cornell Medical College, New York, NY
Background/Purpose: Serious infections (SIs) are a major concern in RA patients, significantly contributing to increased mortality. We examined the SI risk associated with bDMARDs compared…
Abstract Number: 2592 • 2017 ACR/ARHP Annual Meeting
Safety, Tolerability, and Pharmacokinetics of Subcutaneous and Intravenous Anifrolumab in Healthy Volunteers
Raj Tummala¹, Tomas Rouse², Anna Berglind² and Linda Santiago³, ¹AstraZeneca, Gaithersburg, MD, ²AstraZeneca, Gothenberg, Sweden, ³MedImmune, LLC, Mountain View, CA
Background/Purpose: Anifrolumab is a fully human anti–interferon-ɑ receptor 1 monoclonal antibody in Phase III development as an intravenous (IV) therapeutic for systemic lupus erythematosus (SLE).…
Abstract Number: 1451 • 2017 ACR/ARHP Annual Meeting
Starting of Biological Dmards May be Postponed in RA Patients with Multimorbidity: Single Centre Real Life Results
Berkan Armagan¹, Alper Sari¹, Abdulsamet Erden¹, Levent Kilic¹, Efe Cem Erdat², Omer Karadag³, Ali Akdogan¹, Sule Apras Bilgen³, Ihsan Ertenli³, Sedat Kiraz¹ and Umut Kalyoncu^1,3, ¹Rheumatology, Hacettepe University Faculty of Medicine, Ankara, Turkey, ²Internal Medicine, Hacettepe University Faculty of Medicine, Ankara, Turkey, ³Department of Internal Medicine, Divison of Rheumatology, Hacettepe University Faculty of Medicine, Ankara, Turkey
Background/Purpose: RA is a burdensome for most of the patients, comorbidities usually provide additional disadvantags the course of RA. The possible effects of comorbidities on…

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