Abstracts tagged "Biologicals"

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: 0225 • ACR Convergence 2020
Prevalence and Probability Assessment of Adverse Drug Reactions in Rheumatoid Arthritis Patients Receiving Intravenous Originator Biologics in Saudi Arabia: A Longitudinal Five Years Follow-up Study
Hawazin Alhazzani¹, Reem Tashkandi¹, Lamia Alzamel¹, Haya Almalag¹, Shiekha Alaujan¹, Abdurhman Alarfaj¹, Hussain Alarfaj¹ and Mohammed Omair¹, ¹King Saud University, Riyadh, Saudi Arabia
Background/Purpose: Biologics have been advocated by guidelines as effective therapies for rheumatoid arthritis (RA)1. Limited longitudinal studies investigated the prevalence and risk factors for developing…
Abstract Number: 0355 • ACR Convergence 2020
Collagen Turnover Markers Are Associated with Active Psoriatic Arthritis and Decrease with Guselkumab Treatment in a Phase-3 Clinical Trial
Georg Schett¹, Matthew J. Loza², Arumugam Palanichamy², Oliver FitzGerald³, Christopher Ritchlin⁴, Frédéric Baribaud⁵ and Kristen Sweet⁵, ¹Friedrich-Alexander-Universität Erlangen- Nuremberg, Erlangen, Germany, ²Janssen Research & Development, LLC, Spring House, ³Conway Institute for Biomolecular Research, University College Dublin, Dublin, Ireland, ⁴Department of Medicine, University of Rochester Medical Center, Rochester, NY, ⁵Janssen Research & Development, LLC, Spring House, PA
Background/Purpose: Guselkumab (GUS), an interleukin-23p19-subunit monoclonal antibody, demonstrated efficacy compared to placebo (PBO) in reducing skin and musculoskeletal signs and symptoms in patients with active…
Abstract Number: 0513 • ACR Convergence 2020
Mass Spectrometry Identifies Novel Biomarkers in Giant Cell Arteritis, Useful in Patients on Interleukin-6 Receptor Blockade
Sebastian Unizony¹, Robert Morris², Johannes Kreuzer², Wilhelm Haas² and John H. Stone¹, ¹Massachusetts General Hospital Rheumatology Unit, Harvard Medical School, Boston, MA, ²Massachusetts General Hospital, Boston, MA
Background/Purpose: We aimed to identify biomarkers of disease activity in giant cell arteritis (GCA) patients treated with prednisone monotherapy and with prednisone in combination with…
Abstract Number: 0714 • ACR Convergence 2020
Response to Abatacept in JIA Categories: Results from the PRCSG/PRINTO JIA Abatacept Phase IV Registry
Daniel J Lovell¹, Nikolay Tzaribachev², Esi Morgan³, Gabriele Simonini⁴, Thomas Griffin⁵, Ekaterina Alexeeva⁶, John Bohnsack⁷, Andrew Zeft⁸, Gerd Horneff⁹, Richard Vehe¹⁰, Valda Stanevicha¹¹, Stacey Tarvin¹², Maria Trachana¹³, Adam Huber¹⁴, Daniel Kietz¹⁵, Ilonka Orban¹⁶, Jason Dare¹⁷, Ivan Foeldvari¹⁸, Pierre Quartier¹⁹, Alyssa Dominique²⁰, Tzuyung Douglas Kou²⁰, Robert Wong²⁰, Alberto Martini²¹, Hermine Brunner³ and Nicolino Ruperto²², ¹PRCSG, Cincinnati Children’s Hospital Medical Center, Cincinnati, OH, ²Pediatric Rheumatology Research Institute, Bad Bramstedt, Germany, ³Cincinnati Children’s Hospital Medical Center, Cincinnati, OH, ⁴Anna Meyer Children's Hospital, Firenze, Italy, ⁵Levine Children's Hospital, Charlotte, NC, ⁶Scientific Center of Children’s Health of RAMS, Moscow, Russia, ⁷University of Utah and Primary Children's Hospital, Cincinnati, OH, ⁸Cleveland Clinic, Cleveland, OH, ⁹Asklepios Clinic Sankt Augustin, Sankt Augustin, Germany, ¹⁰University of Minnesota, Minneapolis, MN, ¹¹Riga Stradins University, Riga, Latvia, ¹²Riley Children’s Health, Indianapolis, IN, ¹³Aristotle University of Thessaloniki, Thessaloníki, Greece, ¹⁴Dalhousie University, Halifax, NS, Canada, ¹⁵Children’s Hospital of Pittsburgh, Pittsburgh, PA, ¹⁶National Institute of Rheumatology and Physiotherapy, Budapest, Hungary, ¹⁷University of Arkansas for Medical Sciences, Little Rock, AR, ¹⁸Hamburg Centre for Pediatric and Adolescent Rheumatology, Hamburg, Germany, ¹⁹Necker-Enfants Malades University Hospital, Assistance Publique-Hopitaux de Paris, Paris, France, ²⁰Bristol-Myers Squibb Company, Princeton, NJ, ²¹PRINTO, Istituto Giannina Gaslini, Genova, Italy, ²²Istituto Giannina Gaslini, Genova, Italy
Background/Purpose: Abatacept, a selective T-cell co-stimulation modulator, has been demonstrated to be well tolerated and effective in JIA in 2 Phase III studies.1,2 The ongoing…
Abstract Number: 0826 • ACR Convergence 2020
Clinical Responses and Patient Flow over 2 Years of Treatment with Abatacept, Including Dose De-Escalation, in Patients with Early, MTX-Naïve, ACPA+ RA: Results from a Phase IIIb Study
Paul Emery¹, Yoshiya Tanaka², Vivian Bykerk³, Clifton Bingham III⁴, Thomas Huizinga⁵, Gustavo Citera⁶, Kuan-Hsiang Gary Huang⁷, Sean Connolly⁸, Yedid Elbez⁹, Robert Wong⁸, Karissa Lozenski⁸ and Roy Fleischmann¹⁰, ¹Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds and NIHR Leeds Biomedical Research Centre, Leeds Teaching Hospitals NHS Trust, Leeds, UK, Leeds, United Kingdom, ²The First Department of Internal Medicine, University of Occupational and Environmental Health, Kitakyushu, Japan, ³Hospital for Special Surgery, New York, NY, ⁴Johns Hopkins University, Baltimore, MD, ⁵Leiden University Medical Center, Leiden, Netherlands, ⁶Instituto de Rehabilitación Psicofísica, Buenos Aires, Argentina, ⁷Bristol-Myers Squibb Company (at time of analysis), Princeton, NJ, ⁸Bristol-Myers Squibb Company, Princeton, NJ, ⁹Excelya, Boulogne-Billancourt, France, ¹⁰Southwestern Medical Center, Metroplex Clinical Research Center, Dallas, TX
Background/Purpose: In the 56-week (wk) induction period (IP) of the Phase IIIb Assessing Very Early RA Treatment (AVERT)-2 trial (NCT02504268), a greater proportion of patients…

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