Abstracts tagged "Biologicals"

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…
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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