Abstracts tagged "Biologicals"

Abstract Number: 0573 • ACR Convergence 2021
Biosimilar to Biosimilar Infliximab Switching in Real-world Patients with Inflammatory Arthritis Followed in the Danish DANBIO Registry: Switch from Originator Infliximab to CT-P13 and Then to GP1111
Hafsah Nabi¹, Bente Glintborg², Anne Gitte Loft³, Oliver Hendricks⁴, Jens Kristian Pedersen⁵, Søren Andreas Just⁶, Rabiah Ahmed⁷, Kamilla Danebod⁷, Heidi Munk⁸, Ada Colic⁹, Asta Linauskas¹⁰, Dorte Vendelbo Jensen¹¹, Johnny Raun¹², Jolanta Grydehøj¹³, Louise Brot Christensen¹⁴, Natalia Manilo¹⁵, Niels Lomborg¹⁶, Salome Kristensen¹⁷, Frank Mehnert¹⁸, Niels Steen Krogh¹⁹ and Merete Hetland²⁰, ¹DANBIO and Copenhagen Center for Arthritis Research (COPECARE), Center for Rheumatology and Spine Diseases, Centre of Head and Orthopedics, Rigshospitalet, Copenhagen, Denmark, ²COPECARE, Centre for Rheumatology and Spine Diseases, Rigshospitalet, Glostrup, Denmark, Glostrup, Denmark, ³Department of Rheumatology, Aarhus University Hospital, Aarhus, Denmark, ⁴Danish Hospital for Rheumatic Diseases, University Hospital of Southern Denmark, Snderborg, Denmark, ⁵Section of Rheumatology, Department of Medicine, Svendborg Hospital – Odense University Hospital, Svendborg, Denmark, ⁶Section of Rheumatology, Dept. of Medicine, Svendborg Hospital, Svendborg, Denmark, ⁷Department of Rheumatology, Center for Rheumatology and Spine Diseases, Centre of Head and Orthopedics, Rigshospitalet, Copenhagen University Hospital, Glostrup, Copenhagen, Denmark, ⁸Department of Rheumatology, Odense University Hospital, Odense, Denmark, ⁹Department of Rheumatology, Zealand University Hospital, Køge, Denmark, ¹⁰Department of Rheumatology, North Denmark Regional Hospital, Hjoerring, Denmark, ¹¹Department of Internal Medicine, Rønne Hospital, Rønne, Denmark, ¹²Department of Rheumatology, Sygehus Lillebælt, Fredericia, Denmark, ¹³Department of Rheumatology, Holstebro Hospital, Holstebro, Denmark, ¹⁴Department of Rheumatology, Gentofte and Herlev Hospital, Copenhagen University Hospital, Gentofte, Denmark, ¹⁵Department of Rheumatology, Frederiksberg Hospital, Frederiksberg, Denmark, ¹⁶Department of Rheumatology, Vejle Hospital Lillebælt, Vejle, Odense C, Denmark, ¹⁷Department of Rheumatology, Aalborg University Hospital, Aalborg, Denmark, ¹⁸Department of Clinical Epidemiology, Aarhus University Hospital, Aarhus, Denmark, ¹⁹ZiteLab ApS, Copenhagen, Denmark, Frederiksberg, Denmark, ²⁰DANBIO and COPECARE, Centre for Rheumatology and Spine Diseases, Rigshospitalet, Glostrup, Denmark
Background/Purpose: In routine care, biosimilar to biosimilar infliximab switching may occur to save costs (=non-medical switching). Previous studies have investigated the efficacy and safety of…
Abstract Number: 0963 • ACR Convergence 2021
Immunogenicity of COVID-19 Vaccines in Patients with Autoimmune and Inflammatory Rheumatic Diseases (AIIRDs)
Gordon Lam¹, Andrew Laster², Sarah McCarter², Heather Gladue³, Ahmad Kashif², Erin Siceloff², Victoria Lackey³, Cheryl Robertson³, Ashley Toci² and Leonard Calabrese⁴, ¹Arthritis and Osteoporosis Consultants of the Carolinas, Cornelius, NC, ²Arthritis and Osteoporosis Consultants of the Carolinas, Charlotte, NC, ³Arthritis & Osteoporosis Consultants of the Carolinas, Charlotte, NC, ⁴Cleveland Clinic, Cleveland, OH
Background/Purpose: AIIRD patients may have a blunted immune response to the COVID-19 vaccines, but this is largely uncharacterized as these individuals were not included in…
Abstract Number: 1329 • ACR Convergence 2021
Guselkumab (TREMFYA®) Maintains Resolution of Dactylitis and Enthesitis in Patients with Active Psoriatic Arthritis: Results Through 2 Years from a Phase 3 Study
Proton Rahman¹, Iain McInnes², Atul Deodhar³, Georg Schett⁴, Philip Mease⁵, May Shawi⁶, Daniel Cua⁷, Jonathan Sherlock⁸, Alexa Kollmeier⁹, Xie Xu⁷, Yusang Jiang⁷, Shihong Sheng⁷, Christopher Ritchlin¹⁰ and Dennis McGonagle¹¹, ¹Department of Medicine, Eastern Health and Memorial University of Newfoundland, St John's, NL, Canada, ²University of Glasgow, School of Medicine, Glasgow, Scotland, United Kingdom, ³Oregon Health & Science University, Portland, OR, ⁴Universitätsklinikum Erlangen, Department of Internal Medicine 3 – Rheumatology and Immunology, Erlangen, Germany, Erlangen, Germany, ⁵Swedish Medical Center/Providence St. Joseph Health and University of Washington, Seattle, WA, ⁶Janssen Immunology Global Commercial Strategy Organization, Toronto, ON, Canada, ⁷Janssen Research & Development, LLC, Spring House, PA, ⁸Janssen Research & Development, LLC and University of Oxford, Spring House, PA, ⁹Janssen Research & Development, LLC, La Jolla, CA, ¹⁰Division of Allergy, Immunology, and Rheumatology, School of Medicine and Dentistry, University of Rochester Medical Center, Rochester, NY, ¹¹University of Leeds, Leeds, United Kingdom
Background/Purpose: Guselkumab (GUS), a selective inhibitor of IL-23, significantly improved the diverse manifestations of active psoriatic arthritis (PsA), including dactylitis and enthesitis, in the DISCOVER…
Abstract Number: 1363 • ACR Convergence 2021
Identification of PsA Phenotypes with Machine Learning Analytics Using Data from a Phase 3 Clinical Trial Program of Guselkumab in a Bio-naïve Population of Patients with PsA
Pascal Richette¹, Marijn Vis², Sarah Ohrndorf³, William Tillett⁴, Marlies Neuhold⁵, Michel van Speybroeck⁶, Elke Theander⁷, Wim Noel⁸, May Shawi⁹, Alexa Kollmeier¹⁰ and Alen Zabotti¹¹, ¹Lariboisiere Hospital, Paris, France, ²Erasmus MC, Badhoevedorp, Netherlands, ³Charité University Medicine Berlin, Berlin, Germany, ⁴Royal National Hospital for Rheumatic Diseases, Bath, United Kingdom, ⁵Janssen-Cilag, Zug, Switzerland, ⁶Janssen Pharmaceutica, Belgium, Belgium, ⁷Janssen Cilag, Lund, Sweden, ⁸Janssen Pharmaceutica, Vilvoorde, Belgium, ⁹Janssen Immunology Global Commercial Strategy Organization, Toronto, ON, Canada, ¹⁰Janssen Research & Development, LLC, La Jolla, CA, ¹¹University of Udine, Udine, Italy
Background/Purpose: Psoriatic arthritis (PsA) is mainly described based on the individual domains or clinical components of the disease.1,2 The aim of this post hoc analysis…
Abstract Number: 1713 • ACR Convergence 2021
Risk of Serious Infections in Offspring Exposed in Utero to Ustekinumab or Vedolizumab
Jonah Gorodensky¹, Sasha Bernatsky¹, Waqqas Afif¹, Yvan St-Pierre², Kristian Filion¹ and Evelyne Vinet³, ¹McGill University, Montréal, QC, Canada, ²Research Institute of the McGill University Health Centre, Montréal, QC, Canada, ³McGill University Health Centre, Mont Royal, QC, Canada
Background/Purpose: Ustekinumab, an IL-12/23 inhibitor, is indicated in adult patients with inflammatory bowel disease (IBD), psoriasis (PsO), and psoriatic arthritis (PsA) and vedolizumab, an α4β7…
Abstract Number: 1806 • ACR Convergence 2021
Designing a Phase 3b, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Investigate the Effect of Guselkumab (TREMFYA®/sup>) Dosing Interval in Psoriatic Arthritis Patients with Inadequate Response to Tumor Necrosis Factor Inhibition
Alexis Ogdie-Beatty¹, Joseph Merola², Philip Mease³, Christopher Ritchlin⁴, Jose Scher⁵, Daphne Chan⁶, Soumya Chakravarty⁷, Wayne Langholff⁸, Olivia Choi⁹, Yevgeniy Krol⁹, Katelyn Rowland⁹ and Alice Gottlieb¹⁰, ¹University of Pennsylvania, Philadelphia, PA, ²Harvard Medical School, Brigham and Women’s Hospital, Boston, MA, ³Swedish Medical Center/Providence St. Joseph Health and University of Washington, Seattle, WA, ⁴Division of Allergy, Immunology, and Rheumatology, School of Medicine and Dentistry, University of Rochester Medical Center, Rochester, NY, ⁵New York University School of Medicine, New York, NY, ⁶Janssen Scientific Affairs, LLC, Spring House, PA, ⁷Janssen Scientific Affairs, LLC and Drexel University College of Medicine, Horsham, PA, ⁸Janssen Research & Development, LLC, Spring House, PA, ⁹Janssen Scientific Affairs, LLC, Horsham, PA, ¹⁰Icahn School of Medicine at Mount Sinai, New York, NY
Background/Purpose: Tumor necrosis factor inhibitors (TNFi) are frequently chosen as the first biologic therapy for patients (pts) with PsA, though a sizeable proportion of pts…
Abstract Number: 0004 • ACR Convergence 2021
Unappreciated Systemic Metabolic Functions of the Canonical B Cell Cytokines, BAFF and APRIL: Regulation of Lipolysis and Non-shivering Thermogenesis and Protection from Obesogenic Diet Induced Weight Gain
Isaac Harley¹, Calvin Chan², Paul Pfluger³, Trompette Aurelien⁴, Traci Stankiewicz⁵, Jessica Allen⁵, Maria Moreno-Fernandez⁵, Michelle Damen⁵, Jarren Oates⁵, Pablo Alarcon⁵, Jessica Doll⁶, Matthew Flick⁷, Leah Flick⁸, Juan Sanchez-Gurmaches⁹, Rajib Mukherjee⁹, Rebekah Karns¹⁰, Michael Helmrath¹¹, Thomas Inge¹², Stuart Weisberg¹³, Sunje Pamp¹⁴, David Relman¹⁵, Randy Seeley¹⁶, Matthias Tschoep¹⁷, Chris Karp¹⁸ and Senad Divanovic⁸, ¹University of Colorado Anschutz Medical Campus, Aurora, CO, ²University of Cincinnati, Cincinnati, OH, ³Technical University of Munich, Munich, Germany, ⁴Le Centre hospitalier universitaire vaudois, Lausanne, Switzerland, ⁵Cincinnati Children's Hospital Medical Center, Division of Immunobiology, Cincinnati, OH, ⁶Cincinnati Children's Hospital Medical Center, Division of Immunobiology, Cincinn, OH, ⁷Division of Experimental Hematology, Cincinnati Children’s Hospital Medical Center, Cincinnati, OH, ⁸Division of Immunobiology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, ⁹Division of Endocrinology, Cincinnati Children’s Hospital Medical Center, Cincinnati, OH, ¹⁰Division of Gastroenterology, Hepatology and Nutrition, Cincinnati Children’s Hospital Medical Center, Cincinnati, OH, ¹¹Pediatric General and Thoracic Surgery, Cincinnati Children’s Hospital Medical Center, Cincinnati, OH, ¹²Department of Surgery, Children’s Hospital Colorado, Aurora, CO, ¹³Columbia University Medical Center, New York, NY, USA, New York, NY, ¹⁴Danmarks Tekniske Universitet, Lyngby, Denmark, ¹⁵Department: Medicine - Med/Infectious Diseases - Stanford University, Stanford, ¹⁶Department of Surgery, Internal Medicine and Nutritional Sciences, University of Michigan, Ann Arbor, MI, ¹⁷Division of Metabolic Diseases, Technische Universität München, Munich, Germany, ¹⁸Division of Molecular Immunology, Cincinnati Children’s Hospital Medical Center, Cincinnati
Background/Purpose: The impact of immune mediators on weight homeostasis and systemic metabolism remains underdefined. Interrogation of resistance to diet-induced obesity in mice lacking a negative…
Abstract Number: 0581 • ACR Convergence 2021
Rheumatoid Arthritis Treatment Patterns in Massachusetts: Informative Findings from Insurance Claims Data
Mark Matza¹, D. Steven Fox², Kay Larholt³, David Fritsche³, Elizabeth Apgar³, Mitesh Puthran³, Gigi Hirsch³ and Marcy Bolster¹, ¹Massachusetts General Hospital, Boston, MA, ²University of Southern California, School of Pharmacy, Los Angeles, CA, ³Massachusetts Institute of Technology (MIT) Center for Biomedical Innovation, Cambridge, MA
Background/Purpose: A real-world current state of RA patients in Massachusetts (MA) is analyzed to provide a novel assessment of demographics, treatment patterns, and clinical settings…
Abstract Number: 0986 • ACR Convergence 2021
Ianalumab (VAY736) Safety and Efficacy in Patients with Sjögren’s Syndrome: 52 Week Results from a Randomized, Placebo-controlled, Phase 2b Dose-ranging Trial
Thomas Dörner¹, Simon J Bowman², Robert Fox³, Xavier Mariette⁴, Athena Papas⁵, Thomas Grader-Beck⁶, Ben A Fisher², Filipe Barcelos⁷, Salvatore De Vita⁸, Hendrik Schulze-Koops⁹, Robert Moots¹⁰, Guido Junge¹¹, Janice Woznicki¹², Monika Sopala¹¹, Wen-Lin Luo¹² and Wolfgang Hueber¹¹, ¹Charite Universitätsmedizin Berlin and Deutsches Rheumaforschungszentrum (DRFZ), Berlin, Germany, ²Department of Rheumatology, University Hospitals Birmingham NHS Foundation Trust, Birmingham, United Kingdom, ³Scripps Memorial Hospital and Research Institute, San Diego, CA, ⁴Université Paris- Saclay, Rheumatology, Paris, France, ⁵Division of Oral Medicine, Tufts School of Dental Medicine, Boston, MA, ⁶Johns Hopkins University, Baltimore, MD, ⁷Instituto Português de Reumatologia, Lisbon, Portugal, ⁸Division of Rheumatology, DAME, University Hospital of Udine, Udine, Italy, ⁹Division of Rheumatology and Clinical Immunology, Department of Internal Medicine IV, University of Munich, Munich, Germany, ¹⁰Academic Rheumatology Department, Aintree University Hospital, Liverpool, United Kingdom, ¹¹Novartis Pharma AG, Basel, Switzerland, ¹²Novartis Pharmaceuticals Corporation, East Hanover, NJ
Background/Purpose: Sjögren’s syndrome (SS) is an autoimmune disease affecting excretory glands and characterized by B-cell hyperactivity. Ianalumab (VAY736) is a human monoclonal antibody to B-cell…
Abstract Number: 1330 • ACR Convergence 2021
Effect of Guselkumab (TREMFYA®), a Selective IL-23p19 Inhibitor, on Axial-Related Endpoints in Patients with Active PsA: Results from a Phase 3, Randomized, Double-blind, Placebo-controlled Study Through 2 Years
Philip Mease¹, Philip S Helliwell², Dafna Gladman³, Denis Poddubnyy⁴, Xenofon Baraliakos⁵, Soumya Chakravarty⁶, Alexa Kollmeier⁷, Xie Xu⁸, Shihong Sheng⁸, Stephen Xu⁸, May Shawi⁹, Désirée van der Heijde¹⁰ and Atul Deodhar¹¹, ¹Swedish Medical Center/Providence St. Joseph Health and University of Washington, Seattle, WA, ²Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, United Kingdom, ³Schroeder Arthritis Institute, Krembil Research Institute, Toronto Western Hospital, Toronto, ON, Canada, ⁴Department of Rheumatology, Charité – Universitätsmedizin, Berlin, Germany, ⁵Rheumazentrum Ruhrgebiet Herne, Ruhr-Universität Bochum, Herne, Germany, ⁶Janssen Scientific Affairs, LLC and Drexel University College of Medicine, Horsham, PA, ⁷Janssen Research & Development, LLC, La Jolla, CA, ⁸Janssen Research & Development, LLC, Spring House, PA, ⁹Janssen Immunology Global Commercial Strategy Organization, Toronto, ON, Canada, ¹⁰Department of Rheumatology, Leiden University Medical Center, Meerssen, Netherlands, ¹¹Oregon Health & Science University, Portland, OR
Background/Purpose: Guselkumab (GUS), a selective IL-23p19 inhibitor, resulted in greater mean improvements in BASDAI scores vs placebo (PBO) at W24 among patients (pts) with active…
Abstract Number: 1391 • ACR Convergence 2021
Rituximab Is Superior to Placebo in Polymyalgia Rheumatica Patients: A Double Blind Randomized Controlled Proof of Principle Trial
Diane Marsman¹, Nathan den Broeder², Frank van den Hoogen³, Alfons den Broeder¹ and Aatke van der Maas⁴, ¹Sint Maartenskliniek, Nijmegen, Gelderland, Netherlands, ²Radboud University Medical Centre, Nijmegen, Gelderland, Netherlands, ³Sint Maartenskliniek, Ubbergen, Gelderland, Netherlands, ⁴St Maartenskliniek, Nijmegen, Gelderland, Netherlands
Background/Purpose: Corticosteroids remain the cornerstone of polymyalgia rheumatica treatment, but their use has several disadvantages such as long treatment duration and glucocorticoid-related adverse events.1,2 Data…
Abstract Number: 1730 • ACR Convergence 2021
Disease Activity and Outcome in Pregnancies of Patients with SpA – Data from the German Pregnancy Register RHEKISS
Anja Weiß¹, Christina Bungartz¹, Jutta Richter², Susanna Späthling-Mestekemper³, Xenofon Baraliakos⁴, Peer Aries⁵, Rebecca Fischer-Betz⁶ and Anja Strangfeld⁷, ¹DRFZ, Berlin, Germany, ²Rheumatology and Hiller Research Unit, Heinrich-Heine-University Duesseldorf, Medical Faculty, Duesseldorf, Germany, ³Rheumapraxis München, München, Germany, ⁴Rheumazentrum Ruhrgebiet Herne, Ruhr-Universität Bochum, Herne, Germany, ⁵Rheumatologie in Hamburg, Hamburg, Germany, ⁶Uniklinik Dsseldorf, Dsseldorf, Germany, ⁷Deutsches Rheuma-Forschungszentrum Berlin, Berlin, Germany
Background/Purpose: SpA is a severe chronic inflammatory disease, which affects quality of life and functional status. It frequently occurs in women of childbearing age. Active…
Abstract Number: 1807 • ACR Convergence 2021
Relationships Between Fatigue and Hemoglobin/C-Reactive Protein Levels and Associations Between Fatigue and Clinical Response in Patients with Active Psoriatic Arthritis: Results from Two Randomized Controlled Trials of Guselkumab (TREMFYA®)
Proton Rahman¹, Philip Mease², Atul Deodhar³, Laure Gossec⁴, Arthur Kavanaugh⁵, Soumya Chakravarty⁶, Alexa Kollmeier⁷, Yan Liu⁸, Xiwu Lin⁸, May Shawi⁹ and Chenglong Han⁸, ¹Department of Medicine, Eastern Health and Memorial University of Newfoundland, St John's, NL, Canada, ²Swedish Medical Center/Providence St. Joseph Health and University of Washington, Seattle, WA, ³Oregon Health & Science University, Portland, OR, ⁴Sorbonne Université; APHP, Rheumatology Department, Pitié-Salpêtrière Hospital, Paris, France, ⁵University of California San Diego, La Jolla, CA, ⁶Janssen Scientific Affairs, LLC and Drexel University College of Medicine, Horsham, PA, ⁷Janssen Research & Development, LLC, La Jolla, CA, ⁸Janssen Research & Development, LLC, Spring House, PA, ⁹Janssen Immunology Global Commercial Strategy Organization, Toronto, ON, Canada
Background/Purpose: Fatigue is a key patient (pt)-reported symptom of psoriatic arthritis (PsA).1,2 Utilizing data from the Phase 3 DISCOVER-1 (D1) and -2 (D2) studies, these…
Abstract Number: 0014 • ACR Convergence 2021
Low Baseline Expression of Pyruvate Kinase and Succinate Dehydrogenase Genes in the Peripheral Blood of Rheumatoid Arthritis Patients Treated with Tofacitinib Is Associated with Clinical Remission at the End of Follow-up
Elena Tchetina¹, Azamat Satybaldyev², Galina Markova¹ and Alexander Lila², ¹Nasonova Research Institute of Rheumatology, Moscow, Russia, ²V.A. Nasonova Reseach Institute of Rheumatology, Moscow, Russia
Background/Purpose: Rheumatoid arthritis (RA) is an autoimmune disease of unknown etiology, which is characterized by erosive arthritis and systemic inflammation. Tofacitinib (TFCN) is a Janus…
Abstract Number: 0638 • ACR Convergence 2021
Improving Safety in Rheumatology Patients by Closing Pre-screening Laboratory Care Gaps
P. Daniel Nicholas¹, Jonida Cote², Dante Grassi¹, Swana Thomas³, Joseph Chronowski¹, David Pugliese⁴ and Eric Newman¹, ¹Geisinger Medical Center, Danville, PA, ²Geisinger Medical Center, Orefield, PA, ³Geisinger Medical Center, Wilkes-Barre, PA, ⁴Geisinger Medical Center, Wilkes Barre, PA
Background/Purpose: The Centers for Disease Control and Prevention and expert rheumatologists recommend screening for HBV and HCV prior to DMARD initiation and the ACR recommends…

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