Abstracts tagged "Biologicals"

Abstract Number: L19 • ACR Convergence 2021
Secukinumab in Giant Cell Arteritis: A Randomized, Parallel-group, Double-blind, Placebo-controlled, Multicenter Phase 2 Trial
Nils Venhoff¹, Wolfgang Schmidt², Raoul Bergner³, Jürgen Rech⁴, Leonore Unger⁵, Hans-Peter Tony⁶, Meryl Mendelson⁷, Christian Sieder⁸, Meron Maricos⁸ and Jens Thiel⁹, ¹Department of Rheumatology and Clinical Immunology, Vasculitis Center Freiburg, Medical Center - University of Freiburg, University of Freiburg, Freiburg, Germany, ²Immanuel Krankenhaus Berlin, Medical Center for Rheumatology Berlin-Buch, Lindenberger Weg 19, 13125 Berlin, Germany, Berlin, Germany, ³Medizinische Klinik A, Klinikum der Stadt Ludwigshafen, Ludwigshafen, Germany, ⁴Department of Internal Medicine 3 - Rheumatology and Immunology, Friedrich-Alexander University (FAU) Erlangen-Nürnberg and Universitätsklinikum Erlangen, 91054,, Erlangen, Germany, ⁵Medical Department 1, Städtisches Klinikum Dresden, Dresden, Germany, ⁶Department of Medicine 2, Rheumatology and Clinical Immunology Oberduerrbachertstr. 697080, Wuerzburg, Germany, ⁷Novartis Pharmaceuticals Corporation, East Hanover, NJ, ⁸Novartis Pharma GmbH, Nuremberg, Germany, ⁹Department of Rheumatology and Clinical Immunology, Vasculitis Center Freiburg, Medical Center - University of Freiburg, University of Freiburg, Freiburg, Germany; Division of Rheumatology and Immunology, Department of Internal Medicine, Medical University of Graz, Graz, Austria
Background/Purpose: Little is known about glucocorticoid-sparing agents in giant cell arteritis (GCA) except for IL-6 inhibition. Secukinumab (SEC) has shown significant improvements in the signs…
Abstract Number: L18 • ACR Convergence 2021
Humoral and Cellular Immune Responses to a Second Dose of COVID-19 Vaccine BNT162b2 in People Receiving Methotrexate or Targeted Immunosuppression: A Cohort Study
Satveer K Mahil¹, Katie Bechman², Antony Raharja¹, Clara Domingo-Vila³, David Baudry¹, Matt Brown², Andrew Cope², Tejus Dasandi¹, Hataf Khan⁴, Thomas Lechmere⁴, Michael Malim⁴, Freya Meynell¹, Emily Pollock³, Kamila Sychowska³, Jonathan Barker¹, Sam Norton⁵, James Galloway², Katie Doores⁴, Timothy Tree³ and Catherine Smith¹, ¹St John’s Institute of Dermatology, Guy’s and St Thomas’ NHS Foundation Trust and King’s College London, London, ²Centre for Rheumatic Diseases, King's College London, London, ³Department of Immunobiology, Faculty of Life Sciences & Medicine, King's College London, London, United Kingdom, ⁴Department of Infectious Diseases, School of Immunology & Microbial Sciences, King's College London, London, United Kingdom, ⁵Psychology Department, Institute for Psychiatry Psychology & Neuroscience, King’s College London, London
Background/Purpose: COVID-19 vaccines have robust immunogenicity in the general population. Data on individuals with immune-mediated inflammatory diseases who are taking immunosuppressants remains limited. Our cohort…
Abstract Number: L12 • ACR Convergence 2021
Neither Add-on nor Withdrawal of Methotrexate Impacts Efficacy of IL12/23 Inhibition in Active PsA: Data from a Multicenter Investigator-initiated Randomized Placebo-controlled Clinical Trial on Arthritis, Dactylitis, Enthesitis, Psoriasis, QoL and Function
Michaela Koehm¹, Tanja Rossmanith², Ann Christina Foldenauer², Eva Herrmann³, Herbert Kellner⁴, Uta Kiltz⁵, Jürgen Rech⁶, Gerd Burmester⁷, David Kofler⁸, Jan Brandt-Jürgens⁹, Christin Jonetzko¹⁰, Harald Burkhardt¹ and Frank Behrens¹, ¹Rheumatology Goethe-University Frankfurt and Fraunhofer Institute for Translational Medicine and Pharmacology ITMP, Frankfurt, Germany, ²Fraunhofer Institute for Translational Medicine and Pharmacology ITMP, Frankfurt, Germany, ³Institute for Biostatistics and Mathematical Modeling, Goethe-Universität Frankfurt, Frankfurt, Germany, ⁴Praxis Prof. Dr. Kellner, München, Germany, ⁵Rheumazentrum Ruhrgebiet, Herne, Germany, ⁶Department of Internal Medicine 3 - Rheumatology and Immunology, Friedrich-Alexander University (FAU) Erlangen-Nürnberg and Universitätsklinikum Erlangen, 91054,, Erlangen, Germany, ⁷Charite Universitaetsmedizin Berlin, Germany and DRFZ, Berlin, Germany, ⁸Universitätsklinikum Köln, Med. Klinik I f. Innere Medizin Immunologische Ambulanz, Köln, Germany, ⁹Rheumatologische Schwerpunktpraxis im Ärztehaus am Walter-Schreiber-Platz, Berlin, Germany, ¹⁰Fraunhofer Insitute for Translational Medicine and Pharmacology ITMP, Frankfurt, Germany
Background/Purpose: Methotrexate (MTX) is often used as first-line DMARD-therapy in active psoriatic arthritis (PsA). Randomized clinical trials usually require treatment failure or intolerance of csDMARD/MTX…
Abstract Number: L07 • ACR Convergence 2021
Depletion of KLRG1+ T Cells in a First-in-human Clinical Trial of ABC008 in Inclusion Body Myositis (IBM)
Niti Goel¹, Dulce Soler-Ferran², Monette Coutreau², Jorge Escobar³, Kate Courtemanche², Merrilee Needham⁴ and Steven Greenberg⁵, ¹Abcuro, Inc.; Duke University, Durham, NC, ²Abcuro, Inc., Newton, MA, ³Abcuro, Inc., Hayward, CA, ⁴Perron Institute, Murdoch University, Perth, Australia, ⁵Brigham and Women's Hospital, Harvard Medical School, Boston, MA
Background/Purpose: Inclusion body myositis (IBM), a relentlessly progressive autoimmune skeletal muscle disease, has no effective available pharmacological therapy. A prominent feature of IBM on microscopy…
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…
Abstract Number: 1153 • ACR Convergence 2021
The Influence of Companions on a Patient’s Decision to Transition to a Biosimilar: A Randomized Controlled Trial
Chiara Gasteiger¹, Katie Groom¹, Maria Lobo², Urte Scholz³, Keith Petrie¹ and Nicola Dalbeth¹, ¹University of Auckland, Auckland, New Zealand, ²Auckland District Health Board, Auckland, New Zealand, ³University of Zurich, Zurich, Switzerland
Background/Purpose: Involving patients in treatment decisions is commonplace in healthcare, but patients are frequently accompanied by a support person (companion). Companions are often actively involved…
Abstract Number: 1332 • ACR Convergence 2021
Validation of the PROMIS-29 Profile in Patients with Active Psoriatic Arthritis Using Data from a Phase 3, Randomized, Placebo-Controlled Study Evaluating Guselkumab (TREMFYA®)
Ana-Maria Orbai¹, Laura Coates², Atul Deodhar³, Christopher Ritchlin⁴, Alexa Kollmeier⁵, Marlies Neuhold⁶, Yi-Hsuan Liu⁷, Yan Liu⁷ and Chenglong Han⁷, ¹Division of Rheumatology, Johns Hopkins University School of Medicine, Baltimore, MD, ²Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, United Kingdom, ³Oregon Health & Science University, Portland, OR, ⁴Division of Allergy, Immunology, and Rheumatology, School of Medicine and Dentistry, University of Rochester Medical Center, Rochester, NY, ⁵Janssen Research & Development, LLC, La Jolla, CA, ⁶Janssen-Cilag, Zug, Switzerland, ⁷Janssen Research & Development, LLC, Spring House, PA
Background/Purpose: It is important to assess symptoms of pain, fatigue, anxiety, depression, sleep disturbance, and impaired physical function in patients (pts) with psoriatic arthritis (PsA),…
Abstract Number: 1424 • ACR Convergence 2021
Secukinumab Treatment in Children and Adolescents with Enthesitis-related Arthritis and Juvenile Psoriatic Arthritis: Efficacy and Safety Results from a Phase 3 Study
Hermine Brunner¹, Ivan Foeldvari², Ekaterina Alexeeva³, Nuray Ayaz⁴, Inmaculada Calvo Penads⁵, Ozgur Kasapcopur⁶, Vyacheslav Chasnyk⁷, Markus Hufnagel⁸, Zbigniew Zuber⁹, Grant Schulert¹, Seza Ozen¹⁰, Artem Popov¹¹, Athimalaipet Ramanan¹², Christiaan Scott¹³, Betul Sozeri¹⁴, Elena Zholobova¹⁵, Xuan Zhu¹⁶, Sarah Whelan¹⁷, Luminita Pricop¹⁸, Angelo Ravelli¹⁹, Alberto Martini²⁰, Daniel Lovell²¹ and Nicolino Ruperto²², ¹Cincinnati Children's Hospital Medical Center, Cincinnati, OH, ²Hamburger Zentrum fuer Kinder- und Jugendrheumatologie, Hamburg, Germany, ³Scientific Center of Children Health of RAMS, Moscow, Russia, ⁴Istanbul University, İstanbul, Turkey, ⁵Hospital Universitario y Politécnico La Fe, Valencia, Spain, ⁶Istanbul University-Cerrahpasa, İstanbul, Turkey, ⁷Saint-Petersburg State Pediatric Medical Academy, Saint Petersburg, Russia, ⁸Division of Pediatric Infectious Diseases and Rheumatology, Department of Pediatrics and Adolescent Medicine, University Hospital Medical Center Freiburg, Medical Faculty, University of Freiburg, Freiburg, Germany, ⁹Paediatric Rheumatology International Trials Organisation (PRINTO), Lodz, Poland, ¹⁰Hacettepe University Medical Faculty, Ankara, Turkey, ¹¹Ural State Medical University, Yekaterinburg, Russia, ¹²University of Bristol, Bristol, United Kingdom, ¹³Paediatric Rheumatology, University of Cape Town, Cape Town, South Africa, ¹⁴University of Health Sciences, Umraniye Tranining and Research Hospital Division of Pediatric Rheumatology, Istanbul, Turkey, ¹⁵First Moscow State Medical University n.a. I.M.Sechenov, Moscow, Russia, ¹⁶Novartis Pharmaceuticals Corporation, East Hanover, NJ, ¹⁷Novartis, Dublin, Ireland, ¹⁸Novartis Pharmaceutical Corporation, East Hanover, NJ, ¹⁹Istituto Giannina Gaslini, Genoa, Italy, ²⁰IRCCS Istituto G. Gaslini, Università di Genova Pediatria II, Genova, Italy, ²¹Cincinnati Children’s Hospital Medical Center, University of Cincinnati, Cincinnati, OH, ²²IRCCS Istituto Giannina Gaslini; PRINTO, Clinica Pediatrica e Reumatologia, Genova, Italy
Background/Purpose: Enthesitis-related arthritis (ERA) and juvenile psoriatic arthritis (JPsA) are two conditions that represent pediatric correlates of axial spondyloarthritis (axSpA) and adult psoriatic arthritis (PsA),…
Abstract Number: 1736 • ACR Convergence 2021
Treatment of Lupus Nephritis with Belimumab Is Associated with Reduction in Urinary CD23
Emma Weeding¹, Andrea Fava², Chandra Mohan³, Daniel Goldman⁴ and Michelle Petri⁴, ¹Johns Hopkins Hospital, Baltimore, MD, ²Johns Hopkins University, Baltimore, MD, ³University of Houston, Houston, TX, ⁴Johns Hopkins University School of Medicine, Baltimore, MD
Background/Purpose: Urine proteomic approaches have shown promise in identifying dynamic biological pathways in lupus nephritis (LN) which are not captured on renal histopathology or by…
Abstract Number: 1827 • ACR Convergence 2021
Psoriatic Arthritis, Female Sex and Increased Baseline Skin Severity Are Associated with Drug Persistence in Ustekinumab-Treated Patients with Psoriasis in the BADBIR Cohort
Alexis Ogdie¹, William Tillett², Alun Passey³ and Patricia Gorecki⁴, ¹University of Pennsylvania, Philadelphia, PA, ²Royal National Hospital for Rheumatic Diseases, Bath, United Kingdom, ³Janssen Real World Evidence, HEMAR EMEA, High Wycombe, United Kingdom, ⁴Janssen Medical Affairs, London, United Kingdom
Background/Purpose: Skin and joint symptoms both contribute to the burden of disease in psoriatic arthritis (PsA).1 More severe skin symptoms in patients with both skin…
Abstract Number: 0090 • ACR Convergence 2021
Subcutaneous Sarilumab in Hospitalized Patients with Moderate-severe COVID-19 Infection Compared to the Standard Care: An Open-label Randomized Clinical Trial
Sebastián C Rodriguez-García¹, Isidoro Gonzalez-Alvaro¹, Francisco Abad-Santos², Azucena Bautista-Hernández³, Lucio García-Fraile³, Juan Pablo Baldivieso-Achá⁴, Jesús Sanz-Sanz³ and Rosario Garcia de Vicuña¹, ¹Rheumatology Service. La Princesa University Hospital, Madrid, Spain, ²Clinical Pharmacology Service. Clinical Research and Clinical Trials Unit. La Princesa University Hospital, Madrid, Spain, ³Division of Infectious Diseases, Internal Medicine Service. La Princesa University Hospital, Madrid, Spain, ⁴Rheumatology Department. La Princesa University Hospital, Madrid, Spain
Background/Purpose: Many uncertainties remain for IL-6 blockers on the management of COVID-19 such as the optimal time of intervention, the schedule of administration and predictors…
Abstract Number: 0665 • ACR Convergence 2021
Pegloticase Treatment for Uncontrolled Gout in Kidney Transplanted Patients: Results of an On-going Multicenter, Open-Label, Efficacy and Safety Study
Abdul Abdellatif¹, Lin Zhao², Paul M. Peloso³, Katya Cherny², Brad Marder², John D. Scandling⁴ and Kenneth Saag⁵, ¹Kidney Hypertension Transplant Clinic Clear Lake Specialties, Webster, TX, ²Horizon Therapeutics plc, Deerfield, IL, ³Horizon Therapeutics plc, Gurnee, IL, ⁴Stanford Medicine, Department of Nephrology, Stanford, CA, ⁵University of Alabama at Birmingham, Birmingham, AL
Background/Purpose: Gout in kidney transplant (KT) recipients can be severe and particularly challenging to manage. Pegloticase (pegylated recombinant uricase) rapidly metabolizes urate and is a…
Abstract Number: 1154 • ACR Convergence 2021
What Do Patients Know About Biosimilars and How Satisfied Are They with the Educational Process? – A Systematic Comparison Between Rheumatologists and Nurse Specialists, Including Effects of Multiswitching
Sabina Gall, Uta Kiltz, Tanja Kobylinski, Ioana Andreica, Kristina Vaupel, Xenofon Baraliakos and Jürgen Braun, Rheumazentrum Ruhrgebiet Herne, Ruhr-Universität Bochum, Herne, Germany
Background/Purpose: The market share of biosimilars (bsDMARDs) is steadily growing, not only in rheumatologic care. Although data on efficacy, efficiency and safety have been generated…
Abstract Number: 1333 • ACR Convergence 2021
Guselkumab (TREMFYA®) Provides Consistent and Durable Pain Improvement in Patients with Active Psoriatic Arthritis: Results of 2 Phase 3, Randomized, Controlled Clinical Trials
Peter Nash¹, Lai-Shan Tam², Wen-Chan Tsai³, Ying-Ying Leung⁴, Daniel Furtner⁵, Shihong Sheng⁶, Yanli Wang⁶, May Shawi⁷, Alexa Kollmeier⁸, Jonathan Sherlock⁹ and Daniel Cua⁶, ¹Griffith University, Brisbane, Australia, ²Department of Medicine & Therapeutics, The Prince of Wales Hospital, The Chinese University of Hong Kong, Hong Kong, China (People's Republic), ³Janssen Research & Development, LLC, Kaohsiung City, Taiwan (Republic of China), ⁴Singapore General Hospital and Duke-NUS Medical School, Singapore, Singapore, ⁵Janssen, a division of Johnson & Johnson Pte. Ltd., Singapore, Singapore, ⁶Janssen Research & Development, LLC, Spring House, PA, ⁷Janssen Immunology Global Commercial Strategy Organization, Toronto, ON, Canada, ⁸Janssen Research & Development, LLC, La Jolla, CA, ⁹Janssen Research & Development, LLC and University of Oxford, Spring House, PA
Background/Purpose: Guselkumab (GUS), a targeted inhibitor of IL-23p19, demonstrated significant efficacy v placebo (PBO) in achieving ACR20 response at week (W) 24 in patients (pts)…

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