Abstracts tagged "Biologicals"

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…
Abstract Number: 0993 • ACR Convergence 2021
The Mechanistic Basis of anti-CD6 as a Novel Form for the Treatment of Autoimmune Diseases and Cancer
Mikel Gurrea-Rubio¹, Jeffrey Ruth¹, Qi Wu¹, Eliza Pei-Suen Tsou¹, Phillip Campbell¹, Peggy Randon¹, M.Asif Amin¹, Nora Singer², Feng Lin³ and David Fox¹, ¹University of Michigan, Ann Arbor, MI, ²The MetroHealth System, Cleveland, OH, ³Cleveland Clinic, Cleveland, OH
Background/Purpose: The use of Immune Checkpoint Inhibitors (ICIs) is limited by the induction of immune-related adverse events. CD6 is expressed by most T lymphocytes and…
Abstract Number: 1331 • ACR Convergence 2021
Guselkumab (TREMFYA®) Improves Anemia in Patients with Active Psoriatic Arthritis: Results from Two Phase 3 Randomized Controlled Clinical Trials
Arthur Kavanaugh¹, Yan Liu², Proton Rahman³, Philip Mease⁴, Laure Gossec⁵, Xie Xu², Elizabeth Hsia², May Shawi⁶, Chenglong Han², Marlies Neuhold⁷ and Atul Deodhar⁸, ¹University of California San Diego, La Jolla, CA, ²Janssen Research & Development, LLC, Spring House, PA, ³Department of Medicine, Eastern Health and Memorial University of Newfoundland, St John's, NL, Canada, ⁴Swedish Medical Center/Providence St. Joseph Health and University of Washington, Seattle, WA, ⁵Sorbonne Université; APHP, Rheumatology Department, Pitié-Salpêtrière Hospital, Paris, France, ⁶Janssen Immunology Global Commercial Strategy Organization, Toronto, ON, Canada, ⁷Janssen-Cilag, Zug, Switzerland, ⁸Oregon Health & Science University, Portland, OR
Background/Purpose: Anemia related to systemic inflammation can be an important feature of psoriatic arthritis (PsA). Hemoglobin (Hgb) levels have been shown to be inversely related…
Abstract Number: 1405 • ACR Convergence 2021
Effectiveness of Tocilizumab in Cranial and Extracranial Phenotypes of Giant Cell Arteritis: Multicenter Study of 471 Cases
Lara Sánchez-Bilbao¹, Javier Loricera¹, Santos Castañeda², Clara Moriano³, Javier Narvaez⁴, Vicente Aldasoro⁵, Olga Maíz⁶, Rafael Melero⁷, Juan Ignacio Villa⁸, Paloma Vela⁹, Susana Romero-Yuste¹⁰, José Luis Callejas¹¹, Eugenio De Miguel¹², Eva Galindez-Agirregoikoa¹³, Francisca Sivera¹⁴, Jesús Carlos Fernández-López¹⁵, Carles Galisteo¹⁶, Iván Ferraz-Amaro¹⁷, Juan Carlos Nieto¹⁸, Juan Ramón de Dios¹⁹, Julio Sánchez²⁰, Esther Fernández²¹, Isabel de la Morena²², Patricia Moya²³, Roser Solans-Laqué²⁴, Jose Luis Andreu²⁵, Marcelino Revenga²⁶, Eztizen Labrador²⁷, Andrea García-Valle²⁸, Adela Gallego²⁹, Carlota Iñíguez³⁰, Cristina Hidalgo³¹, Noemí Garrido-Puñal³², Ruth López-González³³, José Andrés Román-Ivorra³⁴, Sara Manrique Arija³⁵, Paz Collado³⁶, Enrique Raya¹¹, Francisco Navarro³⁷, Antoni Juan Mas³⁸, Carmen Ordas³⁹, Maria Dolors Boquet⁴⁰, Noelia Álvarez-Rivas⁴¹, Maria Luisa Velloso-Feijoo⁴², Cristina Campos-Fernández⁴³, Íñigo Rúa-Figueroa⁴⁴, Arantxa Conesa⁴⁵, Eva Salgado⁴⁶, Miguel Ángel gonzalez-Gay⁴⁷ and Ricardo Blanco⁴⁸, ¹Hospital Universitario Marqués de Valdecilla, Santander, Spain, ²Hospital Universitario de la Princesa, Madrid, Spain, ³Hospital Universitario de León, León, Spain, ⁴Division of Rheumatology, Hospital Universitario de Bellvitge, Barcelona, Spain, ⁵Complejo Hospitalario de Navarra, Pamplona, Spain, ⁶Hospital Universitario de Donostia, San Sebastián, Spain, ⁷Complexo Hospitalario Universitario de Vigo, Vigo, Galicia, Spain, ⁸Hospital Sierrallana, Torrelavega, Spain, ⁹Hospital General Universitario de Alicante, Alicante, Spain, ¹⁰Complejo Hospitalario Universitario de Pontevedra, Pontevedra, Spain, ¹¹Hospital San Cecilio, Granada, Spain, ¹²Hospital Universitario La Paz, Madrid, Spain, ¹³Hospital Universitario de Basurto, Bilbao, Spain, ¹⁴Hospital Universitario de Elda, Alicante, Spain, ¹⁵Hospital Universitario Juan Canalejo, A Coruña, Spain, ¹⁶Hospital Universitari Parc Tauli, Saadell, Spain, ¹⁷Hospital Universitario de Canarias, Santa Cruz de Tenerife, Spain, ¹⁸Hospital General Universitario Gregorio Marañón, Madrid, Spain, ¹⁹Hospital Universitario de Araba, Mondragón, Spain, ²⁰Hospital Universitario 12 de Octubre, Madrid, Spain, ²¹Hospital Clínico Universitario Virgen de la Arrixaca, Murcia, Spain, ²²Hospital Clínico Universitario de Valencia, Valencia, Spain, ²³Hospital Sant Pau, Barcelona, Spain, ²⁴Hospital Vall d'Hebron, Barcelona, Spain, ²⁵Hospital Universitario Puerta de Hierro, Madrid, Spain, ²⁶Hospital Universitario Ramón y Cajal, Madrid, Spain, ²⁷Hospital San Pedro, Logroño, La Rioja, Spain, ²⁸Complejo Asistencial Universitario de Palencia, Palencia. Spain, Palencia, Spain, ²⁹Complejo Hospitalario Universitario de Badajoz, Badajoz, Spain, ³⁰Hospital Universitario Lucus Augusti, Lugo, Galicia, Spain, ³¹Hospital Universitario Salamanca, Salamanca, Spain, ³²Hospital Universitario Virgen del Rocío, Sevilla, Spain, ³³Complejo Hospitalario de Zamora, Zamora, Spain, ³⁴Hospital Universitario y Politécnico La Fe, Valencia, Spain, ³⁵Hospital Regional de Málaga, Málaga. Spain., Malaga, Spain, ³⁶Hospital Universitario Severo Ochoa, Madrid, Spain, ³⁷Hospital General Universitario de Elche, Elche, Spain, ³⁸Hospital Universitario Son Llàtzer, Palma de Mallorca, Spain, ³⁹Hospital de Cabueñes, Gijón, Spain, ⁴⁰Hospital Arnau de Vilanova, Lleida. Spain., Lleida, Spain, ⁴¹Hospital San Agustín, Aviles, Spain, ⁴²Hospital Universitario de Valme, Sevilla, Spain, ⁴³Consorci Hospital General Universitari de Valencia, Valencia, Spain, ⁴⁴Hospital Universitario Doctor Negrín, Gran Canaria, Spain, ⁴⁵Hospital Universitario de Castellón, Castellón, Spain, ⁴⁶Complejo Hospitalario Universitario de Ourense, Ourense, Spain, ⁴⁷Research group on Genetic Epidemiology and Atherosclerosis in Systemic Diseases and in Metabolic Bone Diseases of the Musculoskeletal System, IDIVAL, Division of Rheumatology, Hospital Universitario Marqués de Valdecilla; School of Medicine, Universidad de Cantabria, Santander, Spain. Cardiovascular Pathophysiology and Genomics Research Unit, School of Physiology, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa, ⁴⁸Hospital Universitario Marqués de Valdecilla, IDIVAL, Santander, Spain
Background/Purpose: Giant cell arteritis (GCA) may be divided into cranial, and extracranial GCA phenotypes. Tocilizumab (TCZ) has shown efficacy and safety in GCA.Our aim was…
Abstract Number: 1734 • ACR Convergence 2021
Efavaleukin Alfa, a Novel IL-2 Mutein, Selectively Expands Regulatory T Cells in Patients with SLE: Interim Results of a Phase 1b Multiple Ascending Dose Study
Nadia Tchao¹, Hamid Amouzadeh², Nandita Sarkar¹, Vincent Chow², Xuguang Hu¹, Mark Kroenke², Hui Wang², Rong Zhang², Kevin Gorski¹, Richard Furie³, Alan Kivitz⁴ and Stanley Cohen⁵, ¹Amgen Inc., South San Francisco, CA, ²Amgen Inc., Thousand Oaks, CA, ³Zucker School of Medicine at Hofstra/Northwell, Great Neck, NY, ⁴Altoona Center for Clinical Research, Duncansville, PA, ⁵Metroplex Clinical Research Center, Dallas, TX
Background/Purpose: Diminished IL-2 as well as both quantitative and qualitative abnormalities in regulatory T cells (Treg) are associated with autoimmune diseases including SLE. Efavaleukin alfa…
Abstract Number: 1824 • ACR Convergence 2021
Secukinumab Treatment Provides Sustained Resolution of Enthesitis at Individual Joints Through 52 Weeks in a Phase 3b, Double-Blind, Randomized, Active-Controlled Study
Gurjit Kaeley¹, Georg Schett², Philip Conaghan³, Dennis McGonagle⁴, Frank Behrens⁵, Philippe Goupille⁶, Corine Gaillez⁷, Bhumik Parikh⁸, Xiangyi Meng⁸ and Catherine Bakewell⁹, ¹University of Florida, Jacksonville, FL, ²Universitätsklinikum Erlangen, Department of Internal Medicine 3 – Rheumatology and Immunology, Erlangen, Germany, Erlangen, Germany, ³Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, United Kingdom, ⁴University of Leeds, Leeds, United Kingdom, ⁵Rheumatology and Fraunhofer ITMP - Translational Medicine and Pharmacology, Goethe University, Frankfurt, Germany, ⁶University hospital of Tours, Rheumatology department, Tours, France, ⁷Novartis Pharma AG, Basel, Switzerland, ⁸Novartis Pharmaceuticals Corporation, East Hanover, NJ, ⁹Intermountain Healthcare Medical Group, Salt Lake City, UT
Background/Purpose: Enthesitis is a key musculoskeletal manifestation of psoriatic arthritis (PsA). In the double-blind, head-to-head EXCEED study (NCT02745080), although the primary endpoint of superiority of…
Abstract Number: 0085 • ACR Convergence 2021
Association of CD20 Inhibitor Use with Severe COVID-19 Outcomes
Naomi Patel¹, Kristin D'Silva¹, Tiffany Hsu², Michael Di Iorio³, Xiaoqing Fu¹, Claire Cook⁴, Lauren Prisco⁵, Lily Martin⁶, Kathleen Vanni⁶, Alessandra Zaccardelli⁶, Yuqing Zhang⁷, Jeffrey Sparks⁶ and Zachary Wallace⁸, ¹Massachusetts General Hospital, Boston, MA, ²Brigham and Women's Hospital, Jamaica Plain, MA, ³Brigham and Women's Hospital, Brookline, MA, ⁴Division of Rheumatology, Allergy, and Immunology, Mass General Hospital, Boston, MA, ⁵Brigham and Women's Hospital, Pound Ridge, MA, ⁶Brigham and Women's Hospital, Boston, MA, ⁷Massachusetts General Hospital, Quincy, MA, ⁸Massachusetts General Hospital, Newton, MA
Background/Purpose: Patients with immune-mediated diseases have similar risk of severe COVID-19 versus the general population but CD20 inhibitor users may be at increased risk of…
Abstract Number: 0639 • ACR Convergence 2021
Improving Pre-biologic Infection Screening Using a Best Practice Alert in Electronic Health Records
Hailey Baker¹, Rebecca Fine¹, Betty Hsiao², Vaidehi Chowdhary³, Lisa Suter⁴ and Abhijeet Danve⁵, ¹Yale University, New Haven, CT, ²Yale-New Haven Medical Center, New Haven, CT, ³Yale University, East Haven, CT, ⁴Yale School of Medicine, New Haven, CT, ⁵Yale University, Rocky Hill, CT
Background/Purpose: Biologics and small molecules (bDMARDs) are important immunomodulatory medications for management of patients with rheumatic diseases. Use of a bDMARD in patients with infection…

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