Abstracts tagged "Biologicals"

Abstract Number: 1303 • ACR Convergence 2021
Associations Between Early Changes in Circulating B Cell Subsets and Severe Flare in Systemic Lupus Erythematosus – Results from Three Phase III Trials of Belimumab
Ioannis Parodis¹, Alvaro Gomez², Julius Lindblom², Alexander Borg², Sharzad Emamikia² and Mariele gatto³, ¹Division of Rheumatology, Department of Medicine Solna, Karolinska Institutet, Karolinska University Hospital, Stockholm, Sweden and Department of Rheumatology, Faculty of Medicine and Health, Örebro University, Örebro, Sweden, ²Division of Rheumatology, Department of Medicine Solna, Karolinska Institutet, Karolinska University Hospital, Stockholm, Sweden, ³Department of Rheumatology, University of Padua, Padua, Italy
Background/Purpose: Belimumab is the only approved targeted treatment for systemic lupus erythematosus (SLE). Identification of early predictors of response or non-response to therapy is imperative…
Abstract Number: 1360 • ACR Convergence 2021
Ultrasound Demonstrates Continued Improvement in Psoriatic Arthritis Synovitis and Enthesitis with Secukinumab: 52-week Results from a Phase III Study
Maria Antonietta D'Agostino¹, Georg Schett², Corine Gaillez³, Carlos Guerrero⁴, PETRA HANOVA⁵, Tomas Cazenave⁶, Maria S. Stoenoiu⁷, Marina Backhaus⁸, Gael Mouterde⁹, Maarten Boers¹⁰, Anne-Marie Duggan¹¹, Punit Goyanka¹² and Philip Conaghan¹³, ¹Rheumatology, Fondazione Policlinico Universitario “Gemelli”, IRCCS, Rome, Italy, ²Universitätsklinikum Erlangen, Department of Internal Medicine 3 – Rheumatology and Immunology, Erlangen, Germany, Erlangen, Germany, ³Novartis Pharma AG, Basel, Switzerland, ⁴Dermatologico Country, Jalisco, Mexico, ⁵Department of Rheumatology, Institute of Rheumatology, Prague, Czech Republic, ⁶Instituto de Rehabilitación Psicofisica, Buenos Aires, Argentina, Buenos Aires, Argentina, ⁷Rheumatology department, Cliniques Universitaires Saint-Luc, Institut de Recherche Expérimentale et Clinique (IREC), Brussels, Belgium, ⁸Department of Internal Medicine, Rheumatology and Clinical Immunology, Park-Klinik Weissensee Academic Hospital of the Charité, Berlin, Germany, Berlin, Germany, ⁹Rheumatology department, CHU Montpellier, Montpellier, France, ¹⁰Department of Epidemiology and Data Science, and Amsterdam Rheumatology and Immunology Center, Amsterdam UMC, Vrije Universiteit, Amsterdam, Netherlands, ¹¹Novartis Ireland Limited, Dublin, Ireland, Dublin, Ireland, ¹²Novartis Healthcare Pvt Ltd, Hyderabad, India, Hyderabad, India, ¹³Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, United Kingdom
Background/Purpose: Power Doppler ultrasound (PDUS) is a sensitive non-invasive imaging tool to visualize a wide range of articular and periarticular inflammation in psoriatic arthritis (PsA).1,2…
Abstract Number: 1686 • ACR Convergence 2021
Efficacy and Safety of Olokizumab in a Phase III Trial of Patients with Moderately to Severely Active Rheumatoid Arthritis Inadequately Controlled by TNF-α Inhibitor Therapy
Eugen Feist¹, Saeed Fatenejad², Sergey Grishin³, Elena Korneva³, Michael Luggen⁴, Evgeniy Nasonov⁵, Mikhail Samsonov⁶ and Roy Fleischmann⁷, ¹Helios Department of Rheumatology, Vogelsang-Gommern, Germany, ²SFC Medica, LLC, Charlotte, NC, ³R-Pharm, Moscow, Russia, ⁴Cincinnati Rheumatic Disease Study Group, Inc., and University Hospital/University of Cincinnati College of Medicine, Cincinnati, OH, ⁵V.A. Nasonova Reseach Institute of Rheumatology, Moscow, Russia, ⁶RPharm, Moscow, Russia, ⁷Metroplex Clinical Research Center and University of Texas Southwestern Medical Center, Dallas, TX
Background/Purpose: Olokizumab (OKZ), a humanized monoclonal antibody targeting IL-6, was studied in patients with active Rheumatoid Arthritis (RA) despite methotrexate (MTX) (NCT02760368, NCT02760407) [1]. Here…
Abstract Number: 1804 • ACR Convergence 2021
Targeted Safety Analyses of Guselkumab (TREMFYA®): Long-term Results from Randomized Clinical Trials in Patients with Active Psoriatic Arthritis and Moderate to Severe Psoriasis
Philip Mease¹, Peter Foley², Kristian Reich³, Soumya Chakravarty⁴, May Shawi⁵, Ya-Wen Yang⁶, Megan Miller⁷, Alexa Kollmeier⁸, Xie Xu⁷, Jenny Yu⁷, Yanli Wang⁷, Shihong Sheng⁷, Yin You⁷ and Iain McInnes⁹, ¹Swedish Medical Center/Providence St. Joseph Health and University of Washington, Seattle, WA, ²University of Melbourne, Carlton, Australia, ³University Medical Center Hamburg-Eppendorf, Hamburg, Germany, ⁴Janssen Scientific Affairs, LLC and Drexel University College of Medicine, Horsham, PA, ⁵Janssen Immunology Global Commercial Strategy Organization, Toronto, ON, Canada, ⁶Janssen Global Services, LLC, Horsham, PA, ⁷Janssen Research & Development, LLC, Spring House, PA, ⁸Janssen Research & Development, LLC, La Jolla, CA, ⁹University of Glasgow, School of Medicine, Glasgow, Scotland, United Kingdom
Background/Purpose: Guselkumab (GUS), a human monoclonal antibody that specifically binds to the p19 subunit of IL-23, demonstrated efficacy and a favorable safety profile in active…
Abstract Number: 0469 • ACR Convergence 2021
Imaging Characteristics in Patients with Spondyloarthritis Using a Novel Heel Enthesitis Magnetic Resonance Imaging Scoring (HEMRIS) System: Post-hoc Analysis of a Phase 3 Secukinumab Trial
Xenofon Baraliakos¹, Philipp Sewerin², Eugenio De Miguel³, Effie Pournara⁴, Christine Kleinmond⁵, Ankita Shekhawat⁶, Annette Wiedon⁷ and Frank Behrens⁸, ¹Rheumazentrum Ruhrgebiet Herne, Ruhr-Universität Bochum, Herne, Germany, ²Department and Hiller Research Unit of Rheumatology, Heinrich Heine University Duesseldorf, Duesseldorf, Germany, ³Hospital Universitario La Paz, Madrid, Spain, ⁴Novartis Pharma AG, Basel, Switzerland, ⁵ClinProject GmbH, Eurasburg, Germany, ⁶Novartis Healthcare Private Limited, Hyderabad, India, ⁷Novartis Pharma GmbH, Nürnberg, Germany, ⁸Rheumatology & Fraunhofer Institute for Translational Medicine and Pharmacology ITMP, Fraunhofer Cluster Immune-Mediated Diseases (CIMD), Fraunhofer Cluster Immune-Mediated Diseases (CIMD), Frankfurt/Main, Germany
Background/Purpose: The heel is a frequently affected anatomical site for enthesitis in spondyloarthritis (SpA).1 Recently, the Outcome Measures in Rheumatology (OMERACT) group developed and validated…
Abstract Number: 0937 • ACR Convergence 2021
Evaluation of the Safety of Vedolizumab in Combination with Other Immunosuppression Biological Therapy in Patients with Inflammatory Bowel Disease
Gino Chesini¹, Elizabeth Parrott¹, Lauren Fox¹, Jenna Beatty¹, Cassandra Effken¹, Na Yu¹, Florence Hosseini-Aslinia¹ and Megan Krause², ¹University of Kansas Medical Center, Kansas City, KS, ²University of Kansas, Kansas City, KS
Background/Purpose: Inflammatory bowel disease (IBD) causes a wide range of symptomology frequently leading to co-management of disease activity between gastroenterologist and rheumatologists. Recently in efforts…
Abstract Number: 1318 • ACR Convergence 2021
Interplay Between Covid-19 and Spondyloarthritis or Its Treatment
Richard Howard¹, Michael Weisman², Hedley Hamilton³, Cassie Shafer¹, Elin Aslanyan¹, John Reveille⁴, Kevin Winthrop⁵, Dongseok Choi⁵, Kimbery Ogle⁵, Sarah Siegel⁵, Emily Papaspyru³, Donna Grims¹ and James T. Rosenbaum⁶, ¹Spondylitis Association of America, Encino, CA, ²Adjunct Professor of Medicine, Stanford University; Distinguished Professor of Medicine Emeritus, David Geffen School of Medicine at UCLA, Los Angeles, CA, ³Any-3, London, United Kingdom, ⁴Division of Rheumatology, The University of Texas Health Science Center at Houston, Houston, TX, ⁵Oregon Health & Science University, Portland, OR, ⁶Departments of Ophthalmology, Medicine, and Cell Biology, Oregon Health & Sciences University and Chair Emeritus, Legacy Devers Eye Institute, Portland, OR
Background/Purpose: The Covid-19 pandemic has been especially challenging for patients with inflammatory diseases including spondyloarthritis (SpA). Patients with rheumatic and musculoskeletal diseases (RMDs) remain at…
Abstract Number: 1361 • ACR Convergence 2021
Impact of Intermediate Treatment Interruption on Secukinumab Efficacy in Patients with Active Psoriatic Arthritis and Ankylosing Spondylitis: Interim Analysis Results from the SERENA Study
Uta Kiltz¹, Petros Sfikakis², Nicola Gullick³, Gkikas Katsifis⁴, Anna Kandyli⁵, Jan Brandt-Jrgens⁶, Philippe Goupille⁷, Nicola Maiden⁸, Karl Gaffney⁹, Maher Aassi¹⁰, Barbara Schulz¹⁰, Effie Pournara¹⁰ and Piotr Jagiello¹⁰, ¹Rheumazentrum Ruhrgebiet Herne, Ruhr-Universität Bochum, Herne, Germany, ²National Kapodistrian University of Athens Medical School, Athens, Greece, Athens, Greece, ³University Hospitals Coventry & Warwickshire, Coventry, United Kingdom, ⁴Rheumatology Clinic Naval Hospital of Athens, Athens, Greece, ⁵Rheumatology Outpatient Clinic, Iaso General Hospital, Athens, Greece, ⁶Rheumatologische Schwerpunktpraxis, Berlin, Germany, ⁷University hospital of Tours, Rheumatology department, Tours, France, ⁸Craigavon Area Hospital, Southern Health & Social Care Trust, Portadown, Craigavon BT63 5QQ, Craigavon, United Kingdom, ⁹Norfolk and Norwich University Hospital NHS Trust, Norwich, United Kingdom, ¹⁰Novartis Pharma AG, Basel, Switzerland
Background/Purpose: Secukinumab (SEC) has demonstrated long-lasting efficacy and a favorable safety profile in patients (pts) with psoriatic arthritis (PsA) and ankylosing spondylitis (AS) across Phase…
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…

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