Abstracts tagged "Biologicals"

Abstract Number: 1701 • ACR Convergence 2021
Evaluation of Cardiovascular Risk Factors and Atherosclerosis in Rheumatoid Arthritis Patients, Treated with Biological Agents: 6-month Follow-up
Georgios Papamichail¹, Theodora Markatseli², Athanasios Georgiadis³, Vasileios Xydis⁴, Haralampos Milionis¹, Alexandros Drosos² and Paraskevi Voulgari², ¹Internal Medicine, Department of Internal Medicine, Medical School, University of Ioannina, Ioannina, Greece, ²Rheumatology Clinic, Department of Internal Medicine, Medical School, University of Ioannina, Ioannina, Greece, ³Private Practice, Ioannina, Greece, Athens, Greece, ⁴Radiology, Department of Radiology, Medical School, University of Ioannina, Ioannina, Greece, Ioannina, Greece
Background/Purpose: Despite new therapeutic approaches in RA, the mortality gap between RA patients and the general population persists, and may even be increasing. Cardiovascular (CV)…
Abstract Number: 1805 • ACR Convergence 2021
Low Rates of Radiographic Progression with 2 Years of Guselkumab (TREMFYA®), a Selective Inhibitor of the Interleukin-23p19 Subunit: Results from a Phase 3, Randomized, Double-blind, Placebo-controlled Study of Biologic-naïve Patients with Active Psoriatic Arthritis
Philip Mease¹, Alice Gottlieb², Iain McInnes³, Proton Rahman⁴, Alexa Kollmeier⁵, Xie Xu⁶, Yusang Jiang⁶, Shihong Sheng⁶, May Shawi⁷, Soumya Chakravarty⁸, Frederic Lavie⁹ and Désirée van der Heijde¹⁰, ¹Swedish Medical Center/Providence St. Joseph Health and University of Washington, Seattle, WA, ²Icahn School of Medicine at Mount Sinai, New York, NY, ³University of Glasgow, School of Medicine, Glasgow, Scotland, United Kingdom, ⁴Department of Medicine, Eastern Health and Memorial University of Newfoundland, St John's, NL, Canada, ⁵Janssen Research & Development, LLC, La Jolla, CA, ⁶Janssen Research & Development, LLC, Spring House, PA, ⁷Janssen Immunology Global Commercial Strategy Organization, Toronto, ON, Canada, ⁸Janssen Scientific Affairs, LLC and Drexel University College of Medicine, Horsham, PA, ⁹Janssen Global Services, LLC, Horsham, PA, ¹⁰Department of Rheumatology, Leiden University Medical Center, Meerssen, Netherlands
Background/Purpose: Guselkumab (GUS), an IL-23p19-subunit inhibitor, is efficacious in treating patients (pts) with psoriasis and psoriatic arthritis (PsA). In the Phase 3, double-blind, placebo (PBO)-controlled…
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…

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